Clinical Trials/NCT02574078

NCT02574078

Completed

Phase 1

A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)

Bristol-Myers Squibb122 sites in 1 country341 target enrollmentNovember 23, 2015

Overview

Phase: Phase 1
Intervention: Bevacizumab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 341
Locations: 122
Primary Endpoint: Overall Survival (OS), Groups A-C Only
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Detailed Description

Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) \*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.

Registry

clinicaltrials.gov

Start Date

November 23, 2015

End Date

April 15, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed locally advanced or stage IV NSCLC
•Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
•Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria

•Untreated or active/progressing Central Nervous system (CNS) metastases
•Active, known or suspected autoimmune disease
•Known history of testing positive for HIV or AIDS
•Active or chronic infection of hepatitis B virus or hepatitis C

Arms & Interventions

Group A SOC maintenance therapy

Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days

Intervention: Bevacizumab

Group A Nivolumab

Opdivo specified dose on specified days

Intervention: Nivolumab

Group A Nivolumab + SOC maintenance therapy

Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days

Intervention: Nivolumab

Group A Nivolumab + SOC maintenance therapy

Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days

Intervention: Bevacizumab

Group A Nivolumab + SOC maintenance therapy

Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days

Intervention: Pemetrexed

Group A SOC maintenance therapy

Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days

Intervention: Pemetrexed

Group B Nivolumab

Opdivo specified dose on specified days

Intervention: Nivolumab

Group B Best supportive care

Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery

Intervention: Best Supportive Care

Group C Investigator's choice chemotherapy

Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days

Intervention: Pemetrexed

Group C Investigator's choice chemotherapy

Intervention: nab-Paclitaxel

Group C Investigator's choice chemotherapy

Intervention: Paclitaxel

Group C Investigator's choice chemotherapy

Intervention: Docetaxel

Group C Investigator's choice chemotherapy

Intervention: Gemcitabine

Group C Investigator's choice chemotherapy

Intervention: Carboplatin

Group C Nivolumb

Opdivo specified dose on specified days

Intervention: Nivolumab

Group D Erlotinib

Erlotinib specified dose on specified days

Intervention: Erlotinib

Group D Nivolumab + Erlotinib

Opdivo/Erlotnib specified dose on specified days

Intervention: Nivolumab

Group D Nivolumab + Erlotinib

Opdivo/Erlotnib specified dose on specified days

Intervention: Erlotinib

Group E Nivolumab + Crizotinib

Opdivo/Crizotinib specified dose on specified days

Intervention: Nivolumab

Group E Nivolumab + Crizotinib

Opdivo/Crizotinib specified dose on specified days

Intervention: Crizotinib

Outcomes

Primary Outcomes

Overall Survival (OS), Groups A-C Only

Time Frame: up to approximately 60 months

Overall survival (OS) is defined as the time from randomization to the date of death.

Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only

Time Frame: up to approximately 60 months

Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.

Progression-Free Survival (PFS), Groups A-D Only

Time Frame: up to approximately 48 months

Progression-free survival (PFS) is defined as the time from randomization 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.