Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

e1. for cohort 1 only: patient currently receiving therapy with an anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti-c5ar. e3. patient presents a contraindication to monalizumab treatment (cohort 1 only) or to avdoralimab (cohort 2 only) as per respective ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. for cohort 1 only: patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may received corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : * major surgery * live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) \< 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen \[hbsag\] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

e1. for cohort 1 only: patient currently receiving therapy with an anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti-c5ar. e3. patient presents a contraindication to monalizumab treatment (cohort 1 only) or to avdoralimab (cohort 2 only) as per respective ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. for cohort 1 only: patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may received corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : * major surgery * live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) \< 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen \[hbsag\] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

Dec. 7, 2020, 12:31 a.m. usa

e1. for cohort 1 only: patient currently receiving therapy with an anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti-c5ar. e3. patient presents a contraindication to monalizumab treatment (cohort 1 only) or to avdoralimab (cohort 2 only) as per respective ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. for cohort 1 only: patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may received corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : - major surgery - live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) < 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen [hbsag] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

e1. for cohort 1 only: patient currently receiving therapy with an anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti-c5ar. e3. patient presents a contraindication to monalizumab treatment (cohort 1 only) or to avdoralimab (cohort 2 only) as per respective ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. for cohort 1 only: patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may received corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : - major surgery - live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) < 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen [hbsag] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

Oct. 26, 2020, 11:31 p.m. usa

e1. for cohort 1 only : patient currently receiving therapy with an anti- pd-1, anti- pd-l1, anti-ctla4 or anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti- il-6 or anti-il-6r or with an anti-c5ar. e3. contraindication to treatment with nivolumab or monalizumab (cohort 1 only) or to tocilizumab or avdoralimab (cohort 2 only) as per respective spc and ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may receive corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : - major surgery. - azithromycine and chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine) - live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) < 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen [hbsag] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

e1. for cohort 1 only : patient currently receiving therapy with an anti- pd-1, anti- pd-l1, anti-ctla4 or anti-nkg2a. e2. for cohort 2 only: patient currently receiving therapy with an anti- il-6 or anti-il-6r or with an anti-c5ar. e3. contraindication to treatment with nivolumab or monalizumab (cohort 1 only) or to tocilizumab or avdoralimab (cohort 2 only) as per respective spc and ib, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. e4. patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine). patients previously exposed to cq, hcq or other quinoline derivates should have interrupted their treatment at least 72h prior to randomization. e5. patient has active autoimmune disease that has required systemic treatment in the past 3 months before the date of randomisation or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents. note 1: patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. patients with hypothyroidism stable on hormone replacement or sjögren's syndrome will not be excluded from the study. note 2: patients may receive corticosteroids as required for the management of sars-cov-2-related symptoms. e6. patient requires the use of one of the following forbidden treatment during the study treatment period, including but not limited to : - major surgery. - azithromycine and chloroquine or any quinoline derivatives (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine) - live vaccines. examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and bcg. seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. flu-mist®) are live attenuated vaccines, and are not allowed. e7. significant cardiovascular disease, such as new york heart association cardiac disease (class ii or greater), myocardial infarction within 3 months prior to the date of randomisation unstable arrhythmias or unstable angina, known left ventricular ejection fraction (lvef) < 50%. note: patients with known coronary artery disease, congestive heart failure not meeting the above criteria must be on a stable medical regimen that is optimized in the opinion of the treating physician and in consultation with a cardiologist if appropriate. e8. patient has known active hepatitis b (chronic or acute; defined as having a positive hepatitis b surface antigen [hbsag] test at screening), known active hepatitis c (patients positive for hepatitis c virus (hcv) antibody are eligible only if pcr is negative for hcv rna at screening) or known human immunodeficiency virus (hiv) infection (hiv 1/2 antibodies). e9. prior allogeneic bone marrow transplantation or solid organ transplant in the past. e10. has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. e11. has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. e12. pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.