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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04151563
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small Cell Lung Cancer Biological: nivolumab Biological: ipilimumab Drug: cabozantinib Biological: docetaxel Biological: ramucirumab Drug: lucitanib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : December 17, 2023
Estimated Study Completion Date : May 13, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A: cabozantinib + nivolumab + ipilimumab Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Biological: ipilimumab
Specified dose on Specified days
Other Name: YERVOY

Drug: cabozantinib
Specified dose on Specified days
Other Name: CABOMETYX

Experimental: Arm B: cabozantinib + nivolumab Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Drug: cabozantinib
Specified dose on Specified days
Other Name: CABOMETYX

Experimental: Arm C: nivolumab + ramucirumab + docetaxel Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Biological: docetaxel
Specified dose on Specified days

Biological: ramucirumab
Specified dose on Specified days
Other Name: CYRAMZA

Experimental: Arm D: lucitanib + nivolumab Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Drug: lucitanib
Specified dose on Specified days
Other Name: CO-3810

Experimental: Arm E: nivolumab + docetaxel Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Biological: docetaxel
Specified dose on Specified days

Active Comparator: Arm F: docetaxel Biological: docetaxel
Specified dose on Specified days




Primary Outcome Measures :
  1. Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment [ Time Frame: approximately 33 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 Years ]
  2. Duration of Response (DOR) by BICR using RECIST 1.1 [ Time Frame: approximately 33 months ]
  3. Progression-Free Survival (PFS) by BICR using RECIST 1.1 [ Time Frame: Up to 5 Years ]
  4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 Years ]
  5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 Years ]
  6. Incidence of Select AEs [ Time Frame: Up to 5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 interstital 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 could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151563


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
Show Show 68 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04151563    
Other Study ID Numbers: CA209-79X
2018-004283-65 ( EudraCT Number )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Nivolumab
Ipilimumab
Ramucirumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological