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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with < 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG4010/Chemotherapy/Nivolumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG4010 | Biological | 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval. |
Not provided
Principal Inclusion Criteria:
Principal Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte | Charlotte | North Carolina | 28204 | United States | ||
| Nashville |
A total of 44 participants were enrolled and treated with at least one administration of each study drug.
The study was conducted at 2 study sites in United States, 4 sites in France, 2 sites in Hungary and 1 site in Belgium.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TG4010/Chemotherapy/Nivolumab | TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2018 | Oct 26, 2021 |
Not provided
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Not provided
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Not provided
| Chemotherapy | Drug | Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance |
|
| Nivolumab | Drug | 360 mg IV administration every 3 weeks |
|
| 28 months |
| Disease Control Rate (DCR) | Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). | 15 months |
| Overall Survival | Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause. The Kaplan-Meier estimator was used to estimate median OS and its confidence interval. | 28 months |
| Duration of Overall Response (DoR) | Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer. | 28 months |
| Number of Participants With Adverse Events or Abnormalities | The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities. | 28 months |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Libramont | Libramont | Belgium |
| Créteil | Créteil | France |
| Mulhouse | Mulhouse | France |
| Rennes | Rennes | France |
| Strasbourg | Strasbourg | France |
| Budapest | Budapest | Hungary |
| Szekesfehervar | Székesfehérvár | Hungary |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TG4010/Chemotherapy/Nivolumab | TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS 0: Fully active, able to carry on all pre-disease performance without restriction ECOG PS 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature | Number | participants |
| |||||||||||||||||
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
| |||||||||||||||||
| PD-L1 percentage of stained cells | Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay (method Dako PD-L1 IHC 22C3 pharmDx assay kit) using tumor tissue from an archival or newly obtained biopsy. Participants with PD-L1 expression ≤50% of tumor cells were eligible to the study. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions. | The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer. | Posted | Number | 90% Confidence Interval | percentage of participants | 15 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | Time from the date of the first study drug administration to the date of first documented tumor progression or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Kaplan-Meier estimator was used to estimate median PFS and its confidence interval. | The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer. | Posted | Median | Inter-Quartile Range | Months | 28 months |
|
| ||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Percentage of participants whose best overall response is either complete response, partial response or stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and no measurable non-target lesions; Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). | The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer. | Posted | Number | 90% Confidence Interval | percentage of participants | 15 months |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival (OS) is defined as the time from the first study drug administration to the date of death due to any cause. The Kaplan-Meier estimator was used to estimate median OS and its confidence interval. | The Evaluable Patient's Population is the primary population for efficacy analyses. Evaluable Patient's Population consists of all participants without major protocol deviation and have at least one baseline and one post-baseline evaluable CT-scan after study treatment start except early disease progression and death due to lung cancer. | Posted | Median | 95% Confidence Interval | Months | 28 months |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Overall Response (DoR) | Time from first documented response (complete response or partial response) until documented disease progression or death due to lung cancer. | Responders: all evaluable participants with complete response or partial response. The start date was the date of first documented response (complete response or partial response) and the end date was the date of first documented disease progression. If no progression has been observed at the cut-off date of analysis or at the date when a subsequent cancer therapy was started, duration of response was censored at the date of the last evaluable tumor assessment. | Posted | Median | Inter-Quartile Range | Weeks | 28 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events or Abnormalities | The assessment of safety of the combination was based mainly on the frequency of adverse events, serious adverse events, adverse events of special interest (Injection site reaction, fatigue, pyrexia, infusion-related reactions and diarrhea), immune-mediated adverse events and laboratories abnormalities. | Safety population (all treated participants) | Posted | Count of Participants | Participants | 28 months |
|
|
Collection of adverse events / serious adverse events starts from the date of signature of the informed consent form up to the safety follow-up visits (100 days after the last administration of any study treatment administration). Timeframe was approximately 28 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TG4010/Chemotherapy/Nivolumab | TG4010: 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks Chemotherapy: Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance Nivolumab: 360 mg IV administration every 3 weeks | 28 | 44 | 28 | 44 | 43 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| AUTOIMMUNE COLITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DUODENITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CONDITION AGGRAVATED | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CHOLANGITIS ACUTE | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BARTHOLINITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BRAIN ABSCESS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Transgene | + 33 (0)3 88 27 91 00 | clinical.trials@transgene.fr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2019 | Oct 26, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C518275 | TG4010 |
| D004358 | Drug Therapy |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| >=65 years |
|
|
| United States |
|
|
| France |
|
|
| ECOG PS 1 |
|
|
| 1 - <50 |
|
| ≥50 |
|
|
|
|
|
|
|