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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002543-41 | EudraCT Number | ||
| 64041757LUC2002 | Other Identifier | Janssen Research & Development, LLC |
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Development of JNJ-64041757 in combination with nivolumab discontinued due to lack of clinical benefit observed in the Phase 1b portion of the study
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The purpose of this study is to evaluate whether the efficacy of JNJ-757 combined with nivolumab is better than the efficacy of nivolumab monotherapy for participants with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung. The open-label study comprises of two parts i.e. Phase 1b (safety run-in) and Phase 2. Phase1b consists of 1 arm whereas Phase 2 is randomized into 2 groups i.e. Group A and Group B.
This study evaluates safety and efficacy of JNJ-64041757 with nivolumab. The total study duration will be up to 3 years. It will consist of safety run-in and randomized phase which will comprise of Screening phase(Day(D) -28 to D -1),Treatment Phase,End of Adverse Event Evaluation Period (100 D after last dose of nivolumab)and Post-treatment Follow-up Phase(Every 3 Months). The primary hypothesis is that addition of JNJ-640417577 to nivolumab will result in higher objective response rate compared with nivolumab monotherapy in at least one of programmed death receptor ligand 1 subgroups in participants with relapsed or refractory StageIIIB or StageIV adenocarcinoma of lung. The study procedures include blood culture bacterial shedding assessments, pharmacokinetics, immunogenicity, and biomarkers. Safety will be monitored throughout study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + JNJ-64041757 | Experimental | Phase 1b and Phase 2 Group A/Arm 1: Participants will receive separate intravenous (IV) infusions of nivolumab and JNJ-64041757 over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study. |
|
| Nivolumab | Active Comparator | Phase 2 Group B/Arm 2: Participants will receive intravenous (IV) infusions of nivolumab over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64041757 | Biological | Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Percentage of Participants With Objective Response | Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). RECIST for CR - disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions. | Up to 6.8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Duration of Objective Response (DOR) | Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States | ||
The trial consisted of two parts (Phase 1 b and Phase 2). However, Phase 2 was not conducted due to early termination of the study. All analyses were performed on Phase 1b data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b: JNJ-64041757+ Nivolumab | Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2018 |
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|
| Nivolumab | Drug | Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle. |
|
| Up to 6.8 months |
| Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression) | Number of participants with PFS event (progressed or died before progression) were reported. PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. | Up to 6.8 months |
| Phase 1b: Number of Participants With Overall Survival (OS) Event (Died) | Number of participants with OS event (died) were reported. Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause. | Up to 6.8 months |
| Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment. | Up to 6.8 months |
| Phase 1b: Number of Participants With Positive Blood Culture | Number of participants with surveillance cultures positive for listeriosis were reported. | Up to 6.8 months |
| Phase 1b: Number of Participants With Bacterial Shedding | Number of participants with bacterial shedding were reported. The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva. | Up to 6.8 months |
| Phase 1b: Serum Concentrations of Nivolumab | Nivolumab serum concentrations were reported. | Up to 6.8 months |
| Phase 1b: Number of Participants With Anti-nivolumab Antibodies | Number of participants with antibodies to nivolumab were reported. | Up to 6.8 months |
| Tennessee Oncology, PLLC |
| Nashville |
| Tennessee |
| 37201 |
| United States |
| Medical Oncology Associates, PS | Spokane | Washington | 99208-1129 | United States |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Hosp. Univ. Quiron Dexeus | Barcelona | 08028 | Spain |
| Hosp. Gral. Univ. de Elche | Elche | 03203 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hosp Regional Univ de Malaga | Málaga | 29010 | Spain |
| Hosp. Son Llatzer | Palma de Mallorca | 07198 | Spain |
| Hosp. Arnau de Vilanova de Valencia | Valencia | 46015 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The all treated analysis population consisted of participants who received at least 1 dose of study agent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: JNJ-64041757+ Nivolumab | Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | 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 | Phase 1b: Percentage of Participants With Objective Response | Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). RECIST for CR - disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Number | Percentage of participants | Up to 6.8 Months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Phase 1b: Duration of Objective Response (DOR) | Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. Overall number of participants analyzed is zero, since none of the participants had objective response. | Posted | Up to 6.8 months |
| ||||||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression) | Number of participants with PFS event (progressed or died before progression) were reported. PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Count of Participants | Participants | Up to 6.8 months |
| ||||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Overall Survival (OS) Event (Died) | Number of participants with OS event (died) were reported. Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Count of Participants | Participants | Up to 6.8 months |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment. | Safety analysis set included participants who received at least 1 administration of any study medication. | Posted | Count of Participants | Participants | Up to 6.8 months |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Positive Blood Culture | Number of participants with surveillance cultures positive for listeriosis were reported. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Count of Participants | Participants | Up to 6.8 months |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Bacterial Shedding | Number of participants with bacterial shedding were reported. The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Count of Participants | Participants | Up to 6.8 months |
|
| |||||||||||||||||||||||||||
| Secondary | Phase 1b: Serum Concentrations of Nivolumab | Nivolumab serum concentrations were reported. | Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of study agent and had one PK blood sample available. Although PK samples were collected, but assays were not run due to no longer development of compound. | Posted | Up to 6.8 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Phase 1b: Number of Participants With Anti-nivolumab Antibodies | Number of participants with antibodies to nivolumab were reported. | The all treated analysis population consisted of participants who received at least 1 dose of study agent. | Posted | Count of Participants | Participants | Up to 6.8 months |
|
|
Up to 6.8 months
Safety analysis set included participants who received at least 1 administration of any study medication.
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 | Phase 1b: JNJ-64041757+ Nivolumab | Participants received nivolumab 240 milligram (mg) intravenous (IV) infusion followed by JNJ-64041757 (1*10^9 colony-forming units [CFUs]) IV infusion on Day 1 and nivolumab 240 mg IV infusion on Day 15 of each 28-day cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study. | 5 | 12 | 5 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatic Failure | Hepatobiliary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Limb Discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Inferior Vena Caval Occlusion | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
Sponsor did not proceed to Randomized phase 2 of study or enroll additional participants in phase 1b as study was stopped early, that resulted in limited evaluation of planned participant-related outcomes, PK, immunogenicity and biomarker analyses.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Nov 23, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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|
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