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.
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
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab in combination with Ipilimumab | BMS-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
Name | Type | Description | Interventions |
---|
Nivolumab in combination with Ipilimumab | Experimental | Specified 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: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 20, 2021