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CheckMate 79X: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04151563
Collaborator
Clovis Oncology, Inc. (Industry), Exelixis (Industry), Eli Lilly and Company (Industry)
0
Enrollment
23
Locations
6
Arms
60.9
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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
Anticipated Study Start Date :
Apr 15, 2021
Anticipated Primary Completion Date :
Dec 17, 2023
Anticipated Study Completion Date :
May 13, 2026

Arms and Interventions

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 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:
  • OPDIVO
  • BMS-936558

    • 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:
  • OPDIVO
  • BMS-936558

    • 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:
  • OPDIVO
  • BMS-936558

    • 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:
  • OPDIVO
  • BMS-936558

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

    Biological: docetaxel
    Specified dose on Specified days

    Outcome Measures

    Primary Outcome Measures

    1. Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment [approximately 33 months]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to 5 Years]

    2. Duration of Response (DOR) by BICR using RECIST 1.1 [approximately 33 months]

    3. Progression-Free Survival (PFS) by BICR using RECIST 1.1 [Up to 5 Years]

    4. Incidence of Adverse Events (AEs) [Up to 5 Years]

    5. Incidence of Serious Adverse Events (SAEs) [Up to 5 Years]

    6. Incidence of Select AEs [Up to 5 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Detroit Michigan United States 48201
    2 Local Institution Ciudad Autónoma De Buenos Aires Buenos Aires Argentina 1426
    3 Local Institution Buenos Aires Distrito Federal Argentina 1431
    4 Local Institution Buenos Aires Distrito Federal Argentina C1199ABB
    5 Local Institution Caba Distrito Federal Argentina 1430
    6 Local Institution Capital Distrito Federal Argentina C1280
    7 Local Institution Charleroi Belgium 6000
    8 Local Institution Gilly Belgium 6060
    9 Local Institution Leuven Belgium 3000
    10 Local Institution Copenhagen Ø Denmark 2100
    11 Local Institution Athens Greece 11527
    12 Local Institution Neo Faliro Greece 18547
    13 Local Institution Torreon Coahuila Mexico 27010
    14 Local Institution Ciudad de México Distrito Federal Mexico 03240
    15 Local Institution Zapopan Jalisco Mexico 44280
    16 Local Institution Heroica Puebla de Zaragoza Puebla Mexico 72530
    17 Local Institution Amsterdam Netherlands 1066 CX
    18 Local Institution Rotterdam Netherlands 3015 GD
    19 Local Institution Oslo Norway 0379
    20 Local Institution Warszawa Mazowieckie Poland 02-781
    21 Local Institution Krakow Poland 30-688
    22 Local Institution Craiova Romania 200347
    23 Local Institution Timisoara Romania 300696

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Clovis Oncology, Inc.
    • Exelixis
    • Eli Lilly and Company

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04151563
    Other Study ID Numbers:
    • CA209-79X
    • 2018-004283-65
    First Posted:
    Nov 5, 2019
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Docetaxel
    Nivolumab
    Ipilimumab
    Ramucirumab

    Study Results

    No Results Posted as of Mar 22, 2022