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

Phase 4

Completed

Conditions: Lung Cancer

Interventions: Drug: Nivolumab in combination with Ipilimumab

Registration Number: NCT02869789

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1041

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab in combination with Ipilimumab	Nivolumab in combination with Ipilimumab	Specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)	From first dose to 100 days post last dose (Up to approximately 29 months)	imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)	From first dose to 30 days post last dose (Up to approximately 27 months)	Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	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)	DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)	From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)	FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale. Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.
Overall Survival (OS)	From first dosing date to the date of death (Up to approximately 67 months)	OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.
Objective Response Rate (ORR)	From first dosing date up to approximately 67 months	ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progression Free Survival (PFS)	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)	PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.

Trial Locations

Locations (136): Local Institution - 0121
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Birmingham, Alabama, United States
Local Institution - 0148
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Phoenix, Arizona, United States
Local Institution - 0085
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Tucson, Arizona, United States
Local Institution - 0164
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Little Rock, Arkansas, United States
Local Institution - 0146
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Bakersfield, California, United States
Marin Cancer Care, Inc
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Greenbrae, California, United States
Los Angeles Hematology/Oncology Medical Group
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Los Angeles, California, United States
Local Institution - 0115
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Los Angeles, California, United States
Torrance Health Association
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Redondo Beach, California, United States
Va San Diego Healthcare System
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San Diego, California, United States
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Local Institution - 0121
🇺🇸Birmingham, Alabama, United States