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FRACTION-GC: A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02935634
Collaborator
Clovis Oncology, Inc. (Industry)
190
Enrollment
35
Locations
6
Arms
77.7
Anticipated Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and tolerability of Nivolumab in combination with Ipilimumab or other treatment therapies in participants with advanced gastric cancer.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nivolumab
  • Biological: Ipilimumab
  • Biological: Relatlimab
  • Biological: BMS-986205
  • Drug: Rucaparib
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)
Actual Study Start Date :
Nov 29, 2016
Anticipated Primary Completion Date :
May 21, 2023
Anticipated Study Completion Date :
May 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nivolumab + Ipilimumab

Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    		•
    Experimental: Nivolumab + Relatlimab

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Biological: Relatlimab
    Specified dose on specified days
    Other Names:
  • BMS-986016

    		•
    Experimental: Nivolumab + BMS-986205

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Biological: BMS-986205
    Specified dose on specified days
    Experimental: Nivolumab + Rucaparib

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: Rucaparib
    Specified dose on specified days
    Other Names:
  • Rubraca

    		•
    Experimental: Ipilimumab + Rucaparib

    Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    • Drug: Rucaparib
    Specified dose on specified days
    Other Names:
  • Rubraca

    		•
    Experimental: Nivolumab + Ipilimumab + Rucaparib

    Biological: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
  • Yervoy
  • BMS-734016

    • Drug: Rucaparib
    Specified dose on specified days
    Other Names:
  • Rubraca

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator [Up to 24 months]

    2. Duration of Response (DOR) by RECIST v1.1 by Investigator [Up to 24 months]

    3. Progression-free Survival Rate (PFSR) [Up to 24 months]

    4. Incidence of Adverse Events (AEs) in Part 1 [Approximately 28 Months]

    5. Incidence of Serious Adverse Events (SAEs) in Part 1 [Approximately 28 Months]

    6. Incidence of AEs leading to discontinuation in Part 1 [Approximately 28 Months]

    7. Incidence of deaths in Part 1 [Approximately 28 Months]

    8. Incidence of participants with clinical laboratory abnormalities in Part 1 [Approximately 28 Months]

    Secondary Outcome Measures

    1. Incidence of AEs [Approximately 28 months]

    2. Incidence of SAEs [Approximately 28 months]

    3. Incidence of AEs leading to discontinuation [Approximately 28 months]

    4. Incidence of AEs leading to death [Approximately 28 months]

    5. Incidence of participants with clinical laboratory test abnormalities [Approximately 28 Months]

    Eligibility Criteria

    Criteria

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

    • Inoperable, advanced or metastatic esophageal cancer (EC), gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed predominant adenocarcinoma and/or squamous carcinoma

    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

    • At least 1 lesion with measurable disease

    Exclusion Criteria:

    • HER2-positive tumor and previously untreated with trastuzumab

    • Suspected, known or progressive central nervous system metastases

    • Other active malignancy requiring concurrent intervention

    • Active, known or suspected autoimmune disease

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Phoenix Arizona United States 85054
    2 City Of Hope National Medical Center Duarte California United States 91010-3000
    3 University Of Colorado Aurora Colorado United States 80045
    4 Yale University New Haven Connecticut United States 06520
    5 Local Institution - 0036 Washington District of Columbia United States 20007
    6 UF Health Medical Oncology - Davis Cancer Pavilion Gainesville Florida United States 32610
    7 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    8 John Hopkins Baltimore Maryland United States 21224
    9 Mayo Clinic Rochester Rochester Minnesota United States 55905
    10 Washington University School of Medicine Saint Louis Missouri United States 63110
    11 Local Institution - 0001 Hackensack New Jersey United States 07601
    12 Local Institution - 0007 New York New York United States 10065
    13 Local Institution - 0002 Portland Oregon United States 97225
    14 Local Institution - 0005 Philadelphia Pennsylvania United States 19111
    15 UPMC Pittsburgh Pennsylvania United States 15232
    16 Local Institution - 0004 Seattle Washington United States 98109
    17 Westmead Hospital Westmead New South Wales Australia 2145
    18 Local Institution - 0033 Heidelberg Victoria Australia 3084
    19 Local Institution Randwick Australia 2031
    20 Local Institution Edmonton Alberta Canada T6G 1Z2
    21 Local Institution Vancouver British Columbia Canada V5Z 4E6
    22 Local Institution Ottawa Ontario Canada K1H 8L6
    23 Sunnybrook Research Institution Toronto, Ontario Canada M4N 3M5
    24 Local Institution - 0021 Toronto Ontario Canada M5G 2M9
    25 Nationales Centrum Fur Tumorerkrankungen (Nct) Heidelberg Germany 69120
    26 Universitaetsklinikum Leipzig Leipzig Germany 04103
    27 Local Institution Ramat Gan Israel 52621
    28 Local Institution Tel Aviv Israel 64239
    29 Local Institution - 0014 Milan Lombardia Italy 20141
    30 IRCCS Istituto Nazionale Tumori Milano Milano Italy 20133
    31 Local Institution Amsterdam Netherlands 1081 HV
    32 Local Institution Utrecht Netherlands 3584 CX
    33 Local Institution - 0050 Singapore Singapore 169610
    34 Local Institution - 0041 Chur Graubünden (de) Switzerland 7000
    35 Local Institution - 0042 Zuerich Switzerland 8091

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Clovis Oncology, Inc.

    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:
    NCT02935634
    Other Study ID Numbers:
    • CA018-003
    • 2016-002807-24
    First Posted:
    Oct 17, 2016
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Nivolumab
    Ipilimumab
    Rucaparib
    Linrodostat

    Study Results

    No Results Posted as of Aug 19, 2022