Clinical Trials (PDQ®)
|Phase I||Treatment||Active||18 and over||Pharmaceutical / Industry||CA209-012|
There is no formal research hypothesis to be statistically tested in this protocol.
- 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.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Trial Lead Organizations/Sponsors
Bristol-Myers Squibb Company - New York
|Bristol-Myers Squibb||Study Director|
|Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:|
|Santa Monica UCLA Medical Center|
|Jonathan Goldman, Site 005||Ph: 310-633-8400|
|Yale Cancer Center|
|Scott Gettinger, Site 014||Ph: 203-737-4156|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Scott Antonia, Site 013||Ph: 813-745-3905|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Julie Brahmer, Site 001||Ph: 443-287-4114|
|Memorial Sloan-Kettering Cancer Center|
|Naiyer Rizvi, Site 010||Ph: 646-888-4204|
|Duke Cancer Institute|
|Neal Ready, Site 004||Ph: 919-681-4768|
|Fox Chase Cancer Center - Philadelphia|
|Hossein Borghaei, Site 016||Ph: 215-214-1472|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|David E Gerber, Site 006||Ph: 214-648-6551|
|Seattle Cancer Care Alliance|
|Laura Chow, Site 007||Ph: 206-288-7445|
|Margaret and Charles Juravinski Cancer Centre|
|Rosalyn Juergens, Site 008||Ph: 905-387-9711 Ext.64423|
|Princess Margaret Hospital|
|Frances A Shepherd, Site 003||Ph: 416-946-4501 Ext.5132|
|The Ottawa Hospital Cancer Centre|
|Scott Laurie, Site 002||Ph: 613-737-7700 Ext.70550|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01454102
ClinicalTrials.gov processed this data on September 29, 2014
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