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Trial record 1 of 1 for:    CA018-003
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A Study to Test Combination Treatments in Participants 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 : December 2, 2022
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
Advanced Gastric Cancer Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Biological: BMS-986205 Drug: Rucaparib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 29, 2016
Estimated Primary Completion Date : May 21, 2023
Estimated Study Completion Date : May 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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 Name: 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 Name: Rubraca
Experimental: Ipilimumab + Rucaparib Biological: Ipilimumab
Specified dose on specified days
Other Names:
  • Yervoy
  • BMS-734016

Drug: Rucaparib
Specified dose on specified days
Other Name: 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 Name: Rubraca


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator [ Time Frame: Up to 24 months ]
  2. Duration of Response (DOR) by RECIST v1.1 by Investigator [ Time Frame: Up to 24 months ]
  3. Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 months ]
  4. Incidence of Adverse Events (AEs) in Part 1 [ Time Frame: Approximately 28 Months ]
  5. Incidence of Serious Adverse Events (SAEs) in Part 1 [ Time Frame: Approximately 28 Months ]
  6. Incidence of AEs leading to discontinuation in Part 1 [ Time Frame: Approximately 28 Months ]
  7. Incidence of deaths in Part 1 [ Time Frame: Approximately 28 Months ]
  8. Incidence of participants with clinical laboratory abnormalities in Part 1 [ Time Frame: Approximately 28 Months ]

Secondary Outcome Measures :
  1. Incidence of AEs [ Time Frame: Approximately 28 months ]
  2. Incidence of SAEs [ Time Frame: Approximately 28 months ]
  3. Incidence of AEs leading to discontinuation [ Time Frame: Approximately 28 months ]
  4. Incidence of AEs leading to death [ Time Frame: Approximately 28 months ]
  5. Incidence of participants with clinical laboratory test abnormalities [ Time Frame: Approximately 28 Months ]

Eligibility Criteria
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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

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
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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): NCT02935634


Locations
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United States, Arizona
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
United States, California
Local Institution - 0020
Duarte, California, United States, 91010-3000
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Local Institution - 0032
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Local Institution - 0036
Washington, District of Columbia, United States, 20007
United States, Florida
UF Health Medical Oncology - Davis Cancer Pavilion
Gainesville, Florida, United States, 32610
Local Institution - 0038
Jacksonville, Florida, United States, 32224
United States, Maryland
John Hopkins
Baltimore, Maryland, United States, 21224
United States, Minnesota
Local Institution - 0017
Rochester, Minnesota, United States, 55905
United States, Missouri
Local Institution - 0003
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Local Institution - 0001
Hackensack, New Jersey, United States, 07601
United States, New York
Local Institution - 0007
New York, New York, United States, 10065
United States, Oregon
Local Institution - 0002
Portland, Oregon, United States, 97225
United States, Pennsylvania
Local Institution - 0005
Philadelphia, Pennsylvania, United States, 19111
UPMC
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Local Institution - 0004
Seattle, Washington, United States, 98109
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Local Institution - 0033
Heidelberg, Victoria, Australia, 3084
Australia
Local Institution
Randwick, Australia, 2031
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution - 0025
Toronto,, Ontario, Canada, M4N 3M5
Local Institution - 0021
Toronto, Ontario, Canada, M5G 2M9
Germany
Local Institution - 0039
Heidelberg, Germany, 69120
Local Institution - 0043
Leipzig, Germany, 04103
Israel
Local Institution
Ramat Gan, Israel, 52621
Local Institution
Tel Aviv, Israel, 64239
Italy
Local Institution - 0014
Milan, Lombardia, Italy, 20141
IRCCS Istituto Nazionale Tumori Milano
Milano, Italy, 20133
Netherlands
Local Institution
Amsterdam, Netherlands, 1081 HV
Local Institution
Utrecht, Netherlands, 3584 CX
Singapore
Local Institution - 0050
Singapore, Singapore, 169610
Switzerland
Local Institution - 0041
Chur, Graubünden (de), Switzerland, 7000
Local Institution - 0042
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02935634    
Other Study ID Numbers: CA018-003
2016-002807-24 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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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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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Nivolumab
 Ipilimumab
Rucaparib
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors