Created at Source Raw Value Validated value
June 25, 2024, noon usa

* inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: * histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (pd1)/programmed death-ligand 1 (pdl1) inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma participants receiving pd1/pdl1 inhibitors as standard of care therapy) * confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia * confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) * be post allogeneic stem cell transplantation (for any indication) * be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories * age \>=18 years. * history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: * absolute lymphocyte count-minimum value of 200 cells per mcl * absolute neutrophil count-minimum value of 500 cells per mcl * platelets-minimum value of 25,000 cells per mcl * total bilirubin-maximum value of 3.0 x upper limit of normal * aspartate aminotransferase (ast) serum glutamic oxaloacetic transaminase (sgot)/alanine transaminase alt serum glutamic-pyruvic transaminase (sgpt)-maximum value of 5.0 x upper limit of normal * creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) * creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: \>30 ml/min/1.73 m\^2 for participants with creatinine levels above institutional normal. * participants with history of human immunodeficiency virus (hiv) may enroll * participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. * participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. * a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: * intrauterine device. * stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. * hormonal contraceptive tablets. * injectable hormonal contraceptives. * implanted hormonal contraceptives. * cutaneous contraceptive patches. * intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: * male or female condom. * diaphragm. * creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. * ability to understand and the willingness to sign a written informed consent document. * cll participants undergoing bruton tyrosine kinases inhibitors (btki) treatment interruption: must be receiving treatment with a btki for 6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

* inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: * histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (pd1)/programmed death-ligand 1 (pdl1) inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma participants receiving pd1/pdl1 inhibitors as standard of care therapy) * confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia * confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) * be post allogeneic stem cell transplantation (for any indication) * be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories * age \>=18 years. * history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: * absolute lymphocyte count-minimum value of 200 cells per mcl * absolute neutrophil count-minimum value of 500 cells per mcl * platelets-minimum value of 25,000 cells per mcl * total bilirubin-maximum value of 3.0 x upper limit of normal * aspartate aminotransferase (ast) serum glutamic oxaloacetic transaminase (sgot)/alanine transaminase alt serum glutamic-pyruvic transaminase (sgpt)-maximum value of 5.0 x upper limit of normal * creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) * creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: \>30 ml/min/1.73 m\^2 for participants with creatinine levels above institutional normal. * participants with history of human immunodeficiency virus (hiv) may enroll * participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. * participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. * a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: * intrauterine device. * stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. * hormonal contraceptive tablets. * injectable hormonal contraceptives. * implanted hormonal contraceptives. * cutaneous contraceptive patches. * intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: * male or female condom. * diaphragm. * creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. * ability to understand and the willingness to sign a written informed consent document. * cll participants undergoing bruton tyrosine kinases inhibitors (btki) treatment interruption: must be receiving treatment with a btki for 6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

June 11, 2024, 4 p.m. usa

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (pd1)/programmed death-ligand 1 (pdl1) inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma participants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal aspartate aminotransferase (ast) serum glutamic oxaloacetic transaminase (sgot)/alanine transaminase alt serum glutamic-pyruvic transaminase (sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m^2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing bruton tyrosine kinases inhibitors (btki) treatment interruption: must be receiving treatment with a btki for 6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care programmed cell death protein 1 (pd1)/programmed death-ligand 1 (pdl1) inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma participants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal aspartate aminotransferase (ast) serum glutamic oxaloacetic transaminase (sgot)/alanine transaminase alt serum glutamic-pyruvic transaminase (sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m^2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing bruton tyrosine kinases inhibitors (btki) treatment interruption: must be receiving treatment with a btki for 6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

June 10, 2022, 4:30 p.m. usa

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma particpants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma particpants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

June 9, 2022, 4 p.m. usa

None

None

Feb. 19, 2022, 5 p.m. usa

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma particpants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma particpants receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) creatinine clearance (only necessary for participants with elevated creatinine)-for participants with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male participant who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

Dec. 10, 2021, 12:30 a.m. usa

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-minimum value of 200 cells per mcl absolute neutrophil count-minimum value of 500 cells per mcl platelets-minimum value of 25,000 cells per mcl total bilirubin-maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-maximum value of 5.0 x upper limit of normal creatinine-maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

Nov. 17, 2021, 7 p.m. usa

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 200 cells per mcl absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl platelets-grade 3 or lower, corresponding to a minimum value of 25,000 cells per mcl total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) be post allogeneic stem cell transplantation (for any indication) be an adult patient (aged 18 or older) with any malignancy who does not fit any of the above categories age >=18 years. history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 200 cells per mcl absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl platelets-grade 3 or lower, corresponding to a minimum value of 25,000 cells per mcl total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. participants with history of human immunodeficiency virus (hiv) may enroll participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: intrauterine device. stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. hormonal contraceptive tablets. injectable hormonal contraceptives. implanted hormonal contraceptives. cutaneous contraceptive patches. intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: male or female condom. diaphragm. creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. ability to understand and the willingness to sign a written informed consent document. cll participants undergoing btki treatment interruption: must be receiving treatment with a btki for (bullet)6 months prior to vaccination and be willing to hold their treatment for up to 3 weeks around the time of vaccination.

June 11, 2021, 12:32 a.m. usa

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age >=18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary mediastinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age >=18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.

April 23, 2021, 12:31 a.m. usa

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary medistinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age >=18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary medistinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age >=18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.

April 22, 2021, 12:31 a.m. usa

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary medistinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age greater than or equal to 18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.

- inclusion criteria: participants must meet all the inclusion criteria in order to be eligible to participate in the study. participants must have one of the following: - histologically or cytologically confirmed solid tumor receiving a standard of care pd1/pdl1 inhibitor for treatment of their solid tumor (inclusive of hodgkin lymphoma and primary medistinal b-cell lymphoma patients receiving pd1/pdl1 inhibitors as standard of care therapy) - confirmed diagnosis of acute leukemia (myeloid (aml) or lymphoid (all) or other acute leukemia; multiple myeloma; waldenstrom macroglobulinemia - confirmed diagnosis of lymphoma, including small lymphoblastic lymphoma (i.e.,chronic lymphocytic leukemia) - be post allogeneic stem cell transplantation (for any indication) - age greater than or equal to 18 years. - ecog performance status less than or equal to 2 (karnofsky greater than or equal to 50%). - history of adequate organ and marrow function on a recent laboratory assessment (within 4 weeks of administration of vaccine), as defined below: - absolute lymphocyte count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - absolute neutrophil count-grade 3 or lower, corresponding to a minimum value of 500 cells per mcl - platelets-grade 3 or lower, corresponding to a minimum value of 50,000 cells per mcl - total bilirubin-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal - ast(sgot)/alt(sgpt)-grade 2 or lower, corresponding to a maximum value of 5.0 x upper limit of normal - creatinine-grade 2 or lower, corresponding to a maximum value of 3.0 x upper limit of normal (if elevated, use of creatinine calculated clearance will be necessary, as below) --creatinine clearance (only necessary for patients with elevated creatinine)-for patients with chronic kidney disease, a calculated glomerular filtration rate minimum will be required as follows: >30 ml/min/1.73 m2 for participants with creatinine levels above institutional normal. - participants with hematologic malignancies with history of treated central nervous disease, must have had at least 2 consecutive lumbar punctures with no evidence of clinically active central nervous system disease. - participants with history of human immunodeficiency virus (hiv) must be on effective anti-retroviral therapy - participants with history of chronic hepatitis b virus (hbv) must be on suppressive therapy (if indicated) with undetectable viral load. - participants with a known history of hepatitis c virus (hcv) infection must have been treated and cured with an undetectable hcv viral load. for participants with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. - a negative urine/serum pregnancy test for females of childbearing potential. the effects of mrna-1273 vaccine on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for 30 days after the last study treatment. note: a female is considered to be of childbearing potential if she has experienced menarche and is not permanently sterile (i.e., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal (postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause and with a serum follicle-stimulating hormone test result in the postmenopausal range). effective methods of contraception: - intrauterine device. - stable dose of hormonal birth control, such as those listed below, for at least 3 months prior to enrollment. - hormonal contraceptive tablets. - injectable hormonal contraceptives. - implanted hormonal contraceptives. - cutaneous contraceptive patches. - intravaginal hormonal contraceptive rings. at least 1 barrier method. effective barrier methods for use in this study are: - male or female condom. - diaphragm. - creams or gels that contain a chemical to kill sperm if a female patient has a male partner who has had surgery to prevent pregnancy (vasectomy), that will be considered evidence of effective contraception. -ability to understand and the willingness to sign a written informed consent document.