Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
