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Trial record 1 of 1 for:    NCT02935634
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A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02935634
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 14, 2016
First Posted Date  ICMJE October 17, 2016
Last Update Posted Date July 19, 2021
Actual Study Start Date  ICMJE November 29, 2016
Estimated Primary Completion Date April 5, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
  • Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  • Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 months ]
  • Incidence of Adverse Events (AEs) in Part 1 [ Time Frame: Approximately 28 Months ]
  • Incidence of Serious Adverse Events in Part 1 [ Time Frame: Approximately 28 Months ]
  • Incidence of AEs leading to Discontinuation in Part 1 [ Time Frame: Approximately 28 Months ]
  • Incidence of Deaths in Part 1 [ Time Frame: Approximately 28 Months ]
  • Incidence of Clinical Laboratory Abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
  • Duration of Response (DOR) [ Time Frame: Up to 24 weeks ]
  • Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Incidence of Adverse Events (AEs) [ Time Frame: Approximately 28 months ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 28 months ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
  • Incidence of AEs leading to death [ Time Frame: Approximately 28 months ]
  • Incidence of Clinical laboratory test abnormalities [ Time Frame: Approximately 28 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 38 weeks ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 38 weeks ]
  • AEs leading to discontinuation [ Time Frame: Up to 38 weeks ]
  • AEs leading to death [ Time Frame: Up to 38 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer
Official Title  ICMJE A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Brief Summary The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Gastric Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Other Names:
    • Opdivo
    • BMS-936558
  • Biological: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
  • Biological: Relatlimab
    Other Name: BMS-986016
  • Biological: BMS-986205
  • Drug: Rucaparib
    Other Name: Rubraca
Study Arms  ICMJE
  • Active Comparator: Nivolumab (nivo) and Ipilimumab (ipi) Combination
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Nivo and Relatlimab Combination
    Interventions:
    • Biological: Nivolumab
    • Biological: Relatlimab
  • Experimental: Nivo and BMS-986205 Combination
    Interventions:
    • Biological: Nivolumab
    • Biological: BMS-986205
  • Experimental: Nivo and Rucaparib Combination
    Intervention: Drug: Rucaparib
  • Experimental: Ipi with Rucaparib Combination
    Intervention: Drug: Rucaparib
  • Experimental: Nivo with Ipi and rucaparib
    Intervention: Drug: Rucaparib
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 14, 2021)
186
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2016)
910
Estimated Study Completion Date  ICMJE December 18, 2023
Estimated Primary Completion Date April 5, 2023   (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:

  • Advanced Gastric Cancer
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must have at least 1 lesion with measurable disease
  • All participants must have inoperable, advanced, or metastatic EC, GC or GEJ carcinoma and have histologically confirmed predominant adenocarcinoma or squamous cell carcinoma. (sub protocol C)

Exclusion Criteria:

  • Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment
  • Must not have suspected or known central nervous system metastases unless adequately treated
  • Patients/subjects with autoimmune disease
  • Patients/subjects who need daily oxygen therapy
  • Participants who are considered to be refractory or resistant to platinum agents (sub protocol c)
  • Participants who have inability to swallow capsules or pills (sub protocol c)
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could interfere with absorption of orally administered systemic treatments (sub protocol c)
  • Participants with diagnosis or history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). (sub protocol C)
  • Prior treatment with a PARP inhibitor (such as rucaparib, olaparib, niraparib, talozaparib, etc.) or a targeted DNA damage response inhibitor (such as ATM or ataxia telangiectasia and Rad3-related protein [ATR] inhibitor). (sub protocol C)

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   Italy,   Netherlands,   Singapore,   Switzerland,   United States
Removed Location Countries France,   Spain
 
Administrative Information
NCT Number  ICMJE NCT02935634
Other Study ID Numbers  ICMJE CA018-003
2016-002807-24 ( EudraCT Number )
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.
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2021

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