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)
NCT ID: NCT01454102
Last Updated: 2021-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
472 participants
INTERVENTIONAL
2011-12-16
2021-07-23
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Nivolumab + Gemcitabine + Cisplatin
Nivolumab solution intravenously every 3 weeks until progressive disease (PD) or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Gemcitabine solution intravenously on Day 1 and Day 8 of every cycle for 4 cycles
Cisplatin solution intravenously on Day 1 of each cycle for 4 cycles
Nivolumab
Gemcitabine
Cisplatin
Arm B: Nivolumab + Pemetrexed + Cisplatin
Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Pemetrexed solution intravenously on Day 1 of every cycle for 4 cycles
Cisplatin solution intravenously on Day 1 of each cycle for 4 cycles
Nivolumab
Cisplatin
Pemetrexed
Arm C: Nivolumab + Paclitaxel + Carboplatin
Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Paclitaxel solution intravenously on Day 1 of every cycle for 4 cycles
Carboplatin area under curve (AUC) 6 solution intravenously on Day 1 of every cycle for 4 cycles
Nivolumab
Paclitaxel
Carboplatin
Arm D: Nivolumab + Bevacizumab maintenance
Nivolumab solution intravenously every 3 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Bevacizumab administered prior to intravenous infusion on Cycle 1 Day 1 followed by intravenous infusion every 3 weeks on Cycle 2 onwards and until PD or discontinuation due to toxicity
Nivolumab
Bevacizumab
Arm E: Nivolumab + Erlotinib
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered prior to chemotherapy on Day 1 of each cycle
Erlotinib tablet by mouth daily until PD or discontinuation due to toxicity
Nivolumab
Erlotinib
Arm F: Nivolumab
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes
Nivolumab
Arm G: Nivolumab + Ipilimumab
In Squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm H: Nivolumab + Ipilimumab
In non-squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm I: Nivolumab + Ipilimumab
In squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm J: Nivolumab + Ipilimumab
In non-squamous histology subjects (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm K: Nivolumab
In squamous histology subjects (NSCLC)
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered as switch maintenance therapy. A cycle is 2 weeks
Nivolumab
Arm L: Nivolumab
In non-squamous histology subjects (NSCLC)
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered over 60 minutes as switch maintenance therapy. A cycle is 2 weeks
Nivolumab
Arm M: Nivolumab
NSCLC subjects with untreated, asymptomatic brain metastases and have no evidence of cerebral edema
Nivolumab solution intravenously every 2 weeks until PD or discontinuation due to toxicity. Administered for up to an hour as monotherapy. A cycle is 2 weeks
Nivolumab
Arm N: Nivolumab + Ipilimumab
In subjects with any histology (NSCLC)
Nivolumab solution administered intravenously prior to Ipilimumab on Day 1 of each cycle. Combination regimen will be provided for 4 cycles
Ipilimumab solution administered intravenously on Day 1 of each cycle, for 4 cycles
Followed by Nivolumab administered every 2 weeks until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm O: Nivolumab + Ipilimumab
Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm P: Nivolumab + Ipilimumab
Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm Q: Nivolumab + Ipilimumab
Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm R: Nivolumab + Ipilimumab
Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Arm S: Nivolumab + Ipilimumab
Nivolumab at specified dose/schedule until PD or discontinuation due to toxicity
Ipilimumab at specified dose/schedule until PD or discontinuation due to toxicity
Nivolumab
Ipilimumab
Interventions
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Nivolumab
Gemcitabine
Cisplatin
Pemetrexed
Paclitaxel
Carboplatin
Bevacizumab
Erlotinib
Ipilimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Ucla
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Ut Southwestern Medical Center At Dallas
Dallas, Texas, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Local Institution
Hamilton, Ontario, Canada
Local Institution
Ottawa, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Countries
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References
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Gettinger S, Rizvi NA, Chow LQ, Borghaei H, Brahmer J, Ready N, Gerber DE, Shepherd FA, Antonia S, Goldman JW, Juergens RA, Laurie SA, Nathan FE, Shen Y, Harbison CT, Hellmann MD. Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Sep 1;34(25):2980-7. doi: 10.1200/JCO.2016.66.9929. Epub 2016 Jun 27.
Rizvi NA, Hellmann MD, Brahmer JR, Juergens RA, Borghaei H, Gettinger S, Chow LQ, Gerber DE, Laurie SA, Goldman JW, Shepherd FA, Chen AC, Shen Y, Nathan FE, Harbison CT, Antonia S. Nivolumab in Combination With Platinum-Based Doublet Chemotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Sep 1;34(25):2969-79. doi: 10.1200/JCO.2016.66.9861. Epub 2016 Jun 27.
Hellmann MD, Rizvi NA, Goldman JW, Gettinger SN, Borghaei H, Brahmer JR, Ready NE, Gerber DE, Chow LQ, Juergens RA, Shepherd FA, Laurie SA, Geese WJ, Agrawal S, Young TC, Li X, Antonia SJ. Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study. Lancet Oncol. 2017 Jan;18(1):31-41. doi: 10.1016/S1470-2045(16)30624-6. Epub 2016 Dec 5.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-012
Identifier Type: -
Identifier Source: org_study_id
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