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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT02869789
• Date of registration: 12/08/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
• Scientific title: A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
• Date of first enrolment: October 5, 2016
• Target sample size: 1041
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02869789
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina, Belgium, Brazil, Canada, Chile, Czech Republic, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Spain, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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 apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: Nivolumab in combination with Ipilimumab

Primary Outcome(s)

Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) [Time Frame: From first dose to 100 days post last dose (Up to approximately 29 months)]

Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) [Time Frame: From first dose to 30 days post last dose (Up to approximately 27 months)]

Secondary Outcome(s)

Progression Free Survival (PFS) [Time Frame: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)]

Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) [Time Frame: From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)]

Duration of Response (DoR) [Time Frame: From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)]

Objective Response Rate (ORR) [Time Frame: From first dosing date up to approximately 67 months]

Overall Survival (OS) [Time Frame: From first dosing date to the date of death (Up to approximately 67 months)]

Secondary ID(s)

2016-002621-10

CA209-817

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/06/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02869789