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Active, Not Recruiting

Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012) - CA209-012

Updated: 3 March, 2020   |   ClinicalTrials.gov

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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Nivolumab + Gemcitabine + Cisplatin
Drug: Gemcitabine Biological: Nivolumab Drug: Cisplatin
Experimental: Arm B: Nivolumab + Pemetrexed + Cisplatin
Drug: Cisplatin Biological: Nivolumab Drug: Pemetrexed
Experimental: Arm C: Nivolumab + Paclitaxel + Carboplatin
Biological: Nivolumab Drug: Carboplatin Drug: Paclitaxel
Experimental: Arm D: Nivolumab + Bevacizumab maintenance
Drug: Bevacizumab Biological: Nivolumab
Experimental: Arm E: Nivolumab + Erlotinib
Biological: Nivolumab Drug: Erlotinib
Experimental: Arm F: Nivolumab
Biological: Nivolumab
Experimental: Arm G: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm H: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm I: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm J: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm K: Nivolumab
Biological: Nivolumab
Experimental: Arm L: Nivolumab
Biological: Nivolumab
Experimental: Arm M: Nivolumab
Biological: Nivolumab
Experimental: Arm N: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm O: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm P: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm Q: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm R: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab
Experimental: Arm S: Nivolumab + Ipilimumab
Biological: Nivolumab Biological: Ipilimumab

Key Eligibility 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

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Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com