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A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in First-Line or in Switch Maintenance in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

A Multi-arm Phase I Safety Study of Nivolumab in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in First-Line or in Switch Maintenance in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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 pneumonia or pulmonary fibrosis by imaging diagnosis of
the chest or clinical symptoms

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of Nivolumab in combination with chemotherapy measured by frequency of drug related adverse events

Outcome Time Frame:

Up to 100 days after the last dose of study drug (approximately 36 weeks)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Canada: Health Canada

Study ID:

CA209-012

NCT ID:

NCT01454102

Start Date:

December 2011

Completion Date:

September 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Yale Cancer Center New Haven, Connecticut  06520-8028
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Seattle Cancer Care Alliance Seattle, Washington  98109
Duke University Medical Center Durham, North Carolina  27710
The Johns Hopkins University Baltimore, Maryland  21287
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
UCLA Los Angeles, California  90095