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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company
Clovis Oncology, Inc.
Exelixis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings