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A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

NCT01928394

Description:

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Gastric Carcinoma
  • Pancreatic Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With <span class="go-doc-concept go-doc-intervention">Ipilimumab</span> in Subjects With Advanced or Metastatic Solid Tumors

Title

  • Brief Title: A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT01928394

    ORG ID: CA209-032

    NCI ID: 2013-002844-10

    Trial Conditions

    Advanced or Metastatic Solid Tumors

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    To investigate the safety and efficacy of Nivolumab as a single agent or in combination with
    Ipilimumab in 4 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC),
    pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC) and Bladder Cancer (BC).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm N - Nivolumab Experimental Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Arm N-I: Nivolumab+Ipilimumab Experimental Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

    Eligibility Criteria

    For more information regarding BMS clinical trial participation, please visit
    www.BMSStudyConnect.com

    Inclusion Criteria:

    - Subjects with histologically confirmed locally advanced or metastatic disease of the
    following tumor types:

    - Triple Negative Breast Cancer

    - Gastric Cancer

    - Pancreatic Cancer

    - Small Cell Lung Cancer

    - Bladder Cancer

    - Subjects must have measurable disease

    - Eastern Cooperative Oncology Group (ECOG) of 0 or 1

    Exclusion Criteria:

    - Active brain metastases or leptomeningeal metastases

    - Subjects with active, known or suspected autoimmune disease

    - Subjects with a condition requiring systemic treatment with either corticosteroids
    (>10 mg daily prednisone equivalents) or other immunosuppressive medications within
    14 days of treatment

    - Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or
    checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
    anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting
    T cell is also prohibited

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective response rate (ORR) in all assigned subjects as determined by the investigators

    Secondary Outcome Measures

    Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment

    Trial Keywords