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A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy

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ClinicalTrials.gov Identifier: NCT04151563
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 1, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date December 6, 2019
Estimated Study Start Date  ICMJE February 19, 2020
Estimated Primary Completion Date November 27, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
Overall Reponse Rate (ORR) [ Time Frame: approximately 33 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04151563 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • Overall Survival (OS) [ Time Frame: Up to 5 Years ]
  • Duration of Response (DOR) [ Time Frame: approximately 33 months ]
  • Progression-Free Survival (PFS) [ Time Frame: Up to 5 Years ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 Years ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy
Official Title  ICMJE A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L1) Immunotherapy
Brief Summary This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy or Immunotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-small Cell Lung
Intervention  ICMJE
  • Biological: nivolumab
    Specified dose on Specified days
  • Biological: ipilimumab
    Specified dose on Specified days
  • Drug: cabozantinib
    Specified dose on Specified days
  • Drug: docetaxel
    Specified dose on Specified days
  • Biological: ramucirumab
    Specified dose on Specified days
  • Drug: lucitanib
    Specified dose on Specified days
Study Arms  ICMJE
  • Experimental: Arm A: cabozantinib + nivolumab + ipilimumab
    Interventions:
    • Biological: nivolumab
    • Biological: ipilimumab
    • Drug: cabozantinib
  • Experimental: Arm B: cabozantinib + nivolumab
    Interventions:
    • Biological: nivolumab
    • Drug: cabozantinib
  • Experimental: Arm C: nivolumab + ramucirumab + docetaxel
    Interventions:
    • Biological: nivolumab
    • Drug: docetaxel
    • Biological: ramucirumab
  • Experimental: Arm D: lucitanib + nivolumab
    Interventions:
    • Biological: nivolumab
    • Drug: lucitanib
  • Experimental: Arm E: nivolumab + docetaxel
    Interventions:
    • Biological: nivolumab
    • Drug: docetaxel
  • Active Comparator: Arm F: docetaxel
    Intervention: Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 27, 2024
Estimated Primary Completion Date November 27, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Stage IV non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT
  • ECOG Performance Status of ≤ 1
  • Clinically documented or radiographically documented disease progression/recurrence during or after the last dose of treatment
  • Progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially
  • Radiographic disease progression or recurrence during or within 90 days after the last dose of durvalumab for locally advanced disease
  • 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.
  • Toxicities must be 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
  • Active brain 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
  • 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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Mexico,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04151563
Other Study ID Numbers  ICMJE CA209-79X
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Clovis Oncology, Inc.
  • Exelixis
  • Eli Lilly and Company
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP