A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy (CheckMate 79X)

December 17, 2023 updated by: Bristol-Myers Squibb

A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426
        • Local Institution
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1431
        • Local Institution
      • Buenos Aires, Distrito Federal, Argentina, C1199ABB
        • Local Institution
      • Caba, Distrito Federal, Argentina, 1430
        • Local Institution
      • Capital, Distrito Federal, Argentina, C1280
        • Local Institution
  • Belgium
      • Charleroi, Belgium, 6000
        • Local Institution
      • Gilly, Belgium, 6060
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
  • Denmark
      • Copenhagen Ø, Denmark, 2100
        • Local Institution
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Neo Faliro, Greece, 18547
        • Local Institution
  • Mexico
    • Coahuila
      • Torreon, Coahuila, Mexico, 27010
        • Local Institution
    • Distrito Federal
      • Ciudad de México, Distrito Federal, Mexico, 03240
        • Local Institution
    • Jalisco
      • Zapopan, Jalisco, Mexico, 44280
        • Local Institution
    • Puebla
      • Heroica Puebla de Zaragoza, Puebla, Mexico, 72530
        • Local Institution
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution
      • Rotterdam, Netherlands, 3015 GD
        • Local Institution
  • Norway
      • Oslo, Norway, 0379
        • Local Institution
  • Poland
      • Krakow, Poland, 30-688
        • Local Institution
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Local Institution
  • Romania
      • Craiova, Romania, 200347
        • Local Institution
      • Timisoara, Romania, 300696
        • Local Institution
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Inclusion Criteria

  • Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
  • ECOG Performance Status of ≤ 1.
  • Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
  • All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
  • Prior toxicities must have resolved to grade ≤1.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.

Exclusion Criteria

  • Prior treatment with Docetaxel.
  • Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
  • Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
  • EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
  • History of cerebrovascular accident and coagulation disorders.
  • Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
  • Known toxicity on prior checkpoint inhibitor treatment.
  • Participants who received more than one line of anti- PD-1/PD-L1 treatment.
  • Participants who received previous CTLA-4 inhibitor treatment.
  • Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: cabozantinib + nivolumab + ipilimumab
Biological: nivolumab
Specified dose on Specified days
Other Names:
  • BMS-936558
  • OPDIVO
Biological: ipilimumab
Specified dose on Specified days
Other Names:
  • YERVOY
Drug: cabozantinib
Specified dose on Specified days
Other Names:
  • CABOMETYX
Experimental: Arm B: cabozantinib + nivolumab
Biological: nivolumab
Specified dose on Specified days
Other Names:
  • BMS-936558
  • OPDIVO
Drug: cabozantinib
Specified dose on Specified days
Other Names:
  • CABOMETYX
Experimental: Arm C: nivolumab + ramucirumab + docetaxel
Biological: nivolumab
Specified dose on Specified days
Other Names:
  • BMS-936558
  • OPDIVO
Biological: docetaxel
Specified dose on Specified days
Biological: ramucirumab
Specified dose on Specified days
Other Names:
  • CYRAMZA
Experimental: Arm D: lucitanib + nivolumab
Biological: nivolumab
Specified dose on Specified days
Other Names:
  • BMS-936558
  • OPDIVO
Drug: lucitanib
Specified dose on Specified days
Other Names:
  • CO-3810
Experimental: Arm E: nivolumab + docetaxel
Biological: nivolumab
Specified dose on Specified days
Other Names:
  • BMS-936558
  • OPDIVO
Biological: docetaxel
Specified dose on Specified days
Active Comparator: Arm F: docetaxel
Biological: docetaxel
Specified dose on Specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Time Frame: approximately 33 months
approximately 33 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 Years
Up to 5 Years
Duration of Response (DOR) by BICR using RECIST 1.1
Time Frame: approximately 33 months
approximately 33 months
Progression-Free Survival (PFS) by BICR using RECIST 1.1
Time Frame: Up to 5 Years
Up to 5 Years
Incidence of Adverse Events (AEs)
Time Frame: Up to 5 Years
Up to 5 Years
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 5 Years
Up to 5 Years
Incidence of Select AEs
Time Frame: Up to 5 Years
Up to 5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Eli Lilly and Company
Clovis Oncology, Inc.
Exelixis

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2021

Primary Completion (Estimated)

December 17, 2023

Study Completion (Estimated)

May 13, 2026

Study Registration Dates

First Submitted

November 1, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-79X
  • 2018-004283-65 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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