Non-small Cell Lung Cancer
Conditions
Brief summary
* The study is evaluating the safety and tolerability of Nivolumab (BMS-936558) when combined with three platinum-based doublet chemotherapy regimens (Cisplatin/Gemcitabine; Cisplatin/Pemetrexed; and Carboplatin/Paclitaxel) in subjects with NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as maintenance therapy in combination with Bevacizumab/Avastin that will be given after at least 4 cycles of platinum doublet chemotherapy. * The study is evaluating the safety and tolerability of Nivolumab in combination with Erlotinib among epidermal growth factor receptor (EGFR) mutation positive non-squamous NSCLC subjects and as monotherapy in subjects with NSCLC. * The study is evaluating the safety and tolerability of Nivolumab in combination with Ipilimumab in subjects with squamous and non-squamous NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as switch maintenance therapy in subjects with squamous and non-squamous NSCLC. * The study is evaluating the safety and tolerability of Nivolumab as monotherapy among subjects with untreated, asymptomatic brain metastases and no evidence of cerebral edema.
Interventions
BIOLOGICALNivolumab
DRUGGemcitabine
DRUGCisplatin
DRUGPemetrexed
DRUGPaclitaxel
DRUGCarboplatin
DRUGBevacizumab
DRUGErlotinib
BIOLOGICALIpilimumab
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Newly diagnosed and confirmed Stage IIIB/IV NSCLC * Previously treated NSCLC with asymptomatic brain metastases (eligible for Arm M) See additional details below * Men and women aged ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Subject must be chemotherapy naive (except Arm D, K, L and M). Prior use of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) is acceptable. For Arms D, K, and L, subjects must be non-progressors within 42 days after completion of first-line treatment with ≥4 cycles of Platinum Doublet chemotherapy with or without Bevacizumab. See below for Arm M * Either a formalin fixed tissue block or a minimum of 10 slides of tumor sample (archived or fresh) must be available for biomarker evaluation (a local pathologist must review for adequacy of sampling) * Life expectancy of at least 3 months * Prior radiotherapy must have been completed at least 2 weeks prior to study entry For Arm M: * No more than 4 brain metastases * Each brain metastases ≤3 cm in size * No evidence of cerebral edema * Subjects must be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroids for ≥10 days prior to initiation of study treatment * At least 1 measurable target brain lesion \>0.5 cm and no larger than 3 cm in diameter and/or 2 measurable brain target lesions \>0.3 cm * No prior radiation therapy, surgery, or other local therapy for target brain lesions * Must have received at least one prior systemic anticancer therapy for NSCLC
Exclusion criteria
* Subjects with symptomatic brain metastases, spinal cord compression, or intractable back pain due to a compressive or destructive mass * Subjects who require emergent use of systemic steroids, emergent surgery and/or radiotherapy * Any active or history of a known autoimmune disease * Subjects with previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, gastric, or colon cancers or cervical cancers/dysplasia, or breast carcinoma in situ) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period * History of Grade ≥2 neuropathy * Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. |
| Number of Participants Who Experienced Selected Adverse Events | From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and Hypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles: * AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies * AEs that may require immunosuppression (eg, corticosteroids) as part of their management * AEs whose early recognition and management may mitigate severe toxicity * AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization. |
| Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of subjects with selected hepatic laboratory abnormalities is reported. AST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal. |
| Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months) | The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date. TSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months) | ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression. |
| Progression-Free Survival Rate (PFSR) at Week 24 | 24 weeks | Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy). PFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage. |
Countries
Canada, United States
Participant flow
Pre-assignment details
472 participants were enrolled; 376 participants received at least one dose of study treatment
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin Chemotherapy-naive SQ subjects; GEM 1250 mg/m2 Days 1 and 8 with CIS 75 mg/m2 on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 | 12 |
| Arm B: Nivolumab + Pemetrexed + Cisplatin Chemotherapy-naive NSQ subjects; dose de-escalation design; PEM 500 mg/m2 with CIS 75 mg/m2, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 | 15 |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 10 mg/kg Q3W until progression after cycle 4 | 15 |
| Arm D: Nivolumab + Bevacizumab Maintenance NSQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; BEV 15 mg/kg + Nivo 5 mg/kg Q3W until progression | 12 |
| Arm E: Nivolumab + Erlotinib Chemotherapy-naive, subjects with EGFR mutations; ERL 150 mg PO, daily + Nivo 3 mg/kg Q2W until progression | 21 |
| Arm F: Nivolumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W until progression | 52 |
| Arm GH: Nivolumab + Ipilimumab Chemotherapy-naive SQ and NSQ subjects; Nivo 1 mg/kg + Ipi 3 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression | 24 |
| Arm IJ: Nivolumab + Ipilimumab Chemotherapy-naive SQ and NSQ subjects; Nivo 3 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression | 25 |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) SQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression | 13 |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) NSQ subjects who completed \>= 4 cycles of chemotherapy and are nonprogressors; Nivo 3 mg/kg Q2W as switch maintenance therapy until progression | 13 |
| Arm M: Nivolumab Subjects with any histology and untreated, asymptomatic brain metastases; Nivo 3 mg/kg Q2W until progression | 12 |
| Arm N: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg + Ipi 1 mg/kg Q3W for 4 cycles followed by Nivo 3 mg/kg Q2W until progression | 31 |
| Arm O: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 1 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity | 40 |
| Arm P: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q12W until progression or unacceptable toxicity | 38 |
| Arm Q: Nivolumab + Ipilimumab Chemotherapy-naive subjects with any histology; Nivo 3 mg/kg Q2W + Ipi 1 mg/kg Q6W until progression or unacceptable toxicity | 39 |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin Chemotherapy-naive subjects with any histology; dose de-escalation design; PAC 200 mg/m2 with CAR AUC 6, both on Day 1 of a Q3W cycle for up to 4 cycles + Nivo 5 mg/kg Q3W until progression after cycle 4 | 14 |
| Total | 376 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Continuing in the treatment period | 0 | 0 | 0 | 0 | 3 | 3 | 2 | 0 | 1 | 0 | 0 | 4 | 7 | 4 | 3 | 1 |
Baseline characteristics
| Characteristic | Arm A: Nivolumab + Gemcitabine + Cisplatin | Arm B: Nivolumab + Pemetrexed + Cisplatin | Arm C10: Nivolumab + Paclitaxel + Carboplatin | Arm D: Nivolumab + Bevacizumab Maintenance | Arm E: Nivolumab + Erlotinib | Arm F: Nivolumab | Arm GH: Nivolumab + Ipilimumab | Arm IJ: Nivolumab + Ipilimumab | Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Arm M: Nivolumab | Arm N: Nivolumab + Ipilimumab | Arm O: Nivolumab + Ipilimumab | Arm P: Nivolumab + Ipilimumab | Arm Q: Nivolumab + Ipilimumab | Arm C5: Nivolumab + Paclitaxel + Carboplatin | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 6.82 | 60.2 years STANDARD_DEVIATION 11.2 | 58.7 years STANDARD_DEVIATION 8.81 | 62.9 years STANDARD_DEVIATION 9.53 | 62.8 years STANDARD_DEVIATION 9.41 | 67.0 years STANDARD_DEVIATION 9.96 | 60.5 years STANDARD_DEVIATION 6.99 | 63.1 years STANDARD_DEVIATION 8.31 | 63.6 years STANDARD_DEVIATION 10.15 | 68.7 years STANDARD_DEVIATION 12.64 | 62.6 years STANDARD_DEVIATION 12.65 | 61.5 years STANDARD_DEVIATION 10.85 | 64.9 years STANDARD_DEVIATION 11.25 | 65.9 years STANDARD_DEVIATION 9.36 | 64.4 years STANDARD_DEVIATION 9.95 | 64.9 years STANDARD_DEVIATION 9.79 | 64.0 years STANDARD_DEVIATION 9.95 |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 8 Participants | 5 Participants | 13 Participants | 26 Participants | 10 Participants | 12 Participants | 5 Participants | 5 Participants | 8 Participants | 16 Participants | 22 Participants | 21 Participants | 15 Participants | 8 Participants | 188 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 7 Participants | 7 Participants | 8 Participants | 26 Participants | 14 Participants | 13 Participants | 8 Participants | 8 Participants | 4 Participants | 15 Participants | 18 Participants | 17 Participants | 24 Participants | 6 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 16 / 16 | 11 / 13 | 13 / 13 | 11 / 12 | 30 / 31 | 33 / 40 | 35 / 38 | 33 / 39 | 15 / 15 | 29 / 29 | 11 / 12 | 21 / 21 | 50 / 52 | 9 / 9 | 15 / 15 | 9 / 9 |
| serious Total, serious adverse events | 4 / 12 | 12 / 16 | 3 / 13 | 4 / 13 | 4 / 12 | 12 / 31 | 21 / 40 | 25 / 38 | 25 / 39 | 10 / 15 | 17 / 29 | 3 / 12 | 11 / 21 | 23 / 52 | 6 / 9 | 12 / 15 | 5 / 9 |
Outcome results
Primary
Number of Participants Who Experienced Selected Adverse Events
The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and Hypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles: * AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies * AEs that may require immunosuppression (eg, corticosteroids) as part of their management * AEs whose early recognition and management may mitigate severe toxicity * AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization.
Time frame: From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Renal | 1 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 2 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Skin | 3 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 4 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 3 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 6 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Renal | 6 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Skin | 9 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 6 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Skin | 7 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Renal | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 7 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 8 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 2 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 2 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Skin | 5 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Renal | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 2 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 1 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Renal | 2 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 4 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Skin | 16 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 4 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 10 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 2 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 3 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 16 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 4 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 5 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 8 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 27 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 0 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 15 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 3 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 2 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 8 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 15 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 7 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 3 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 6 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 2 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 2 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 12 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 14 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 1 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 2 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 5 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Renal | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Skin | 4 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 2 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Renal | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Skin | 2 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 2 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 1 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 2 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 2 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 0 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 0 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 0 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 0 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 0 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 4 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 4 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 12 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 20 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 2 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 3 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 2 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 15 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 20 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 3 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 13 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 13 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 21 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 3 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 6 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 11 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 8 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 5 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 3 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Skin | 20 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 13 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Renal | 4 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 2 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 12 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Gastrointestinal | 6 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Skin | 7 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Renal | 4 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Pulmonary | 1 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Hepatic | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Endorcrine | 1 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Selected Adverse Events | Hypersensitivity/Infusion Reactions | 1 Participants |
Primary
Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
Time frame: From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)
Population: All treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 4 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 5 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 10 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 8 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 3 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 3 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 11 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 3 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 2 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 23 Participants |
| Arm F: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 9 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 18 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 11 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 2 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 13 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 3 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 17 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 1 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 4 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 4 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 4 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 1 Participants |
| Arm M: Nivolumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 12 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 3 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 4 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 21 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 25 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 10 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 4 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 25 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 2 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 8 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | AEs leading to discontinuation | 2 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | SAEs | 9 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death | Death | 0 Participants |
Primary
Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests
The number of subjects with selected hepatic laboratory abnormalities is reported. AST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal.
Time frame: From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)
Population: All treated participants with baseline and post-baseline measurements
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 2 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 1 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 2 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 1 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 4 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 1 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 2 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 1 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 1 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 2 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 4 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 2 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 1 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 6 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 2 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 3XULN | 2 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 20XULN | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 1 day | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | AST or ALT>3XULN with Bilirubin>2XULN within 30day | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 5XULN | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | TOTAL BILIRUBIN > 2XULN | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests | ALT OR AST > 10XULN | 0 Participants |
Primary
Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests
The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date. TSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal
Time frame: From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)
Population: All treated participants with baseline and post-baseline measurements
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 2 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 2 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 1 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 3 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 3 Participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 7 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 5 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 8 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 7 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 2 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 7 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 8 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 7 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 4 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 12 Participants |
| Arm E: Nivolumab + Erlotinib | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 7 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 4 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 4 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 9 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 21 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 13 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 3 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 14 Participants |
| Arm F: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 6 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 10 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 5 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 3 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 12 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 12 Participants |
| Arm GH: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 10 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 5 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 7 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 5 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 9 Participants |
| Arm IJ: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 6 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 5 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 3 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 2 Participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 3 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 1 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 5 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 6 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 2 Participants |
| Arm M: Nivolumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 2 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 10 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 7 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 6 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 9 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 6 Participants |
| Arm N: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 10 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 12 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 7 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 9 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 7 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 2 Participants |
| Arm O: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 6 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 6 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 6 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 5 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 5 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 11 Participants |
| Arm P: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 4 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 9 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 4 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 8 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 9 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 11 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 7 Participants |
| Arm Q: Nivolumab + Ipilimumab | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH FT3/FT4 TEST MISSING | 3 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN | 5 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH ALL FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH >=1 FT3/FT4 TEST VALUE < LLN | 2 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN | 7 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH >=1 FT3/FT4 TEST VALUE > ULN | 2 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH TSH <= ULN AT BASELINE | 4 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH < LLN WITH TSH >= LLN AT BASELINE | 5 Participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests | TSH > ULN WITH ALL FT3/FT4 TEST VALUES >= LLN | 0 Participants |
Secondary
Objective Response Rate (ORR)
ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression.
Time frame: From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months)
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Objective Response Rate (ORR) | 41.7 Percentage of participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Objective Response Rate (ORR) | 46.7 Percentage of participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Objective Response Rate (ORR) | 46.7 Percentage of participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Objective Response Rate (ORR) | 16.7 Percentage of participants |
| Arm E: Nivolumab + Erlotinib | Objective Response Rate (ORR) | 19.0 Percentage of participants |
| Arm F: Nivolumab | Objective Response Rate (ORR) | 23.1 Percentage of participants |
| Arm GH: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 20.8 Percentage of participants |
| Arm IJ: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 24.0 Percentage of participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Objective Response Rate (ORR) | 0 Percentage of participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Objective Response Rate (ORR) | 15.4 Percentage of participants |
| Arm M: Nivolumab | Objective Response Rate (ORR) | 8.3 Percentage of participants |
| Arm N: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 22.6 Percentage of participants |
| Arm O: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 32.5 Percentage of participants |
| Arm P: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 47.4 Percentage of participants |
| Arm Q: Nivolumab + Ipilimumab | Objective Response Rate (ORR) | 38.5 Percentage of participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Objective Response Rate (ORR) | 50.0 Percentage of participants |
Secondary
Progression-Free Survival Rate (PFSR) at Week 24
Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy). PFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage.
Time frame: 24 weeks
Population: All treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Nivolumab + Gemcitabine + Cisplatin | Progression-Free Survival Rate (PFSR) at Week 24 | 50.5 Percentage of participants |
| Arm B: Nivolumab + Pemetrexed + Cisplatin | Progression-Free Survival Rate (PFSR) at Week 24 | 68.4 Percentage of participants |
| Arm C10: Nivolumab + Paclitaxel + Carboplatin | Progression-Free Survival Rate (PFSR) at Week 24 | 34.3 Percentage of participants |
| Arm D: Nivolumab + Bevacizumab Maintenance | Progression-Free Survival Rate (PFSR) at Week 24 | 58.3 Percentage of participants |
| Arm E: Nivolumab + Erlotinib | Progression-Free Survival Rate (PFSR) at Week 24 | 50.6 Percentage of participants |
| Arm F: Nivolumab | Progression-Free Survival Rate (PFSR) at Week 24 | 39.7 Percentage of participants |
| Arm GH: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 42.8 Percentage of participants |
| Arm IJ: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 37.3 Percentage of participants |
| Arm K: Nivolumab in Squamous Histology Subjects (NSCLC) | Progression-Free Survival Rate (PFSR) at Week 24 | 50.0 Percentage of participants |
| Arm L: Nivolumab in Non-squamous Histology Subjects (NSCLC) | Progression-Free Survival Rate (PFSR) at Week 24 | 20.5 Percentage of participants |
| Arm M: Nivolumab | Progression-Free Survival Rate (PFSR) at Week 24 | 8.3 Percentage of participants |
| Arm N: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 49.1 Percentage of participants |
| Arm O: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 48.0 Percentage of participants |
| Arm P: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 72.4 Percentage of participants |
| Arm Q: Nivolumab + Ipilimumab | Progression-Free Survival Rate (PFSR) at Week 24 | 39.5 Percentage of participants |
| Arm C5: Nivolumab + Paclitaxel + Carboplatin | Progression-Free Survival Rate (PFSR) at Week 24 | 59.3 Percentage of participants |