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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

NCT02869789

Description:

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
  • Official Title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA209-817
  • SECONDARY ID: 2016-002621-10
  • NCT ID: NCT02869789

Conditions

  • Lung Cancer

Interventions

DrugSynonymsArms
Nivolumab in combination with IpilimumabBMS-936558 (Nivolumab), Opdivo (Nivolumab), BMS-734016 (Ipilimumab), Yervoy (Ipilimumab)Nivolumab in combination with Ipilimumab

Purpose

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab in combination with IpilimumabExperimentalSpecified dose on specified days
  • Nivolumab in combination with Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed Stage 4 or recurrent non-small cell lung cancer

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out
             light housework or office work through to being fully active as you were before
             cancer)

          -  No prior systemic anticancer therapy (including EGFR and ALK inhibitors)

          -  Tissue or Programmed death-ligand 1 (PD-L1) results available

        Cohort 1A Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) score 2 or

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria
             as listed in the protocol

        Cohort C Inclusion Criteria:

          -  High Tumor Mutation Burden

        Exclusion Criteria:

          -  Untreated brain metastases

          -  An active malignancy that requires concurrent intervention

          -  Active, known or suspected autoimmune disease

          -  Carcinomatous meningitis, which means there is inflammation of the covering of the
             brain, caused by cancer

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants who experience high grade AEs (Adverse Events)
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, B, and C

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, B, and C
Measure:ORR
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, B, and C
Measure:Duration of Response (DOR)
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, B, and C
Measure:Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, A1, B, and C
Measure:Overall Survival (OS)
Time Frame:Up to 40 months
Safety Issue:
Description:Cohorts A, B, and C

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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