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)

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase ITreatment18 and overCA209-012
NCI-2012-00350, NCT01454102

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

Must have received at least one prior systemic anticancer therapy for NSCLC

No prior radiation therapy, surgery, or other local therapy for target brain lesions

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

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

No evidence of cerebral edema

Each brain metastases ≤3 cm in size

No more than 4 brain metastases

Prior radiotherapy must have been completed at least 2 weeks prior to study entry

For Arm M:

Life expectancy of at least 3 months

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)

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Men and women aged ≥18 years

Previously treated NSCLC with asymptomatic brain metastases (eligible for Arm M) See

additional details below

Newly diagnosed and confirmed Stage IIIB/IV NSCLC

Exclusion Criteria:

Subjects with interstitial lung disease that is symptomatic or may interfere with the

detection or management of suspected drug-related pulmonary toxicity

History of Grade ≥2 neuropathy

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

Any active or history of a known autoimmune disease

Subjects who require emergent use of systemic steroids, emergent surgery and/or

radiotherapy

Subjects with symptomatic brain metastases, spinal cord compression, or intractable

back pain due to a compressive or destructive mass

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Bristol-Myers Squibb

    Trial Sites

    U.S.A.

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Jonathan W Goldman
    Principal Investigator

    Connecticut
    New Haven

    Yale University

    Scott Nicholas Gettinger
    Principal Investigator

    Maryland
    Baltimore

    Johns Hopkins University/Sidney Kimmel Cancer Center

    Julie R. Brahmer
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Naiyer Abbas Rizvi
    Principal Investigator

    North Carolina
    Durham

    Duke University Medical Center

    Neal E. Ready
    Principal Investigator

    Washington
    Seattle

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Laura Q.M. Chow
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01454102

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.