A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

— FRACTION-GC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935634
• Other study ID #: CA018-003
• Secondary ID: 2016-002807-24
• Status: Completed
• Phase: Phase 2
• Start date: November 29, 2016
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days
• Relatlimab
Specified dose on specified days
• BMS-986205
Specified dose on specified days

Drug:
• Rucaparib
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0033	Heidelberg	Victoria
Australia	Local Institution	Randwick
Australia	Local Institution - 0035	Westmead	New South Wales
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution - 0021	Toronto	Ontario
Canada	Local Institution - 0025	Toronto,	Ontario
Canada	Local Institution	Vancouver	British Columbia
Germany	Local Institution - 0039	Heidelberg
Germany	Local Institution - 0043	Leipzig
Israel	Local Institution	Ramat Gan
Israel	Local Institution	Tel Aviv
Italy	Local Institution - 0014	Milan	Lombardia
Italy	IRCCS Istituto Nazionale Tumori Milano	Milano
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Utrecht
Singapore	Local Institution - 0050	Singapore
Switzerland	Local Institution - 0041	Chur	Graubünden (de)
Switzerland	Local Institution - 0042	Zuerich
United States	University Of Colorado	Aurora	Colorado
United States	Local Institution - 0006	Baltimore	Maryland
United States	Local Institution - 0020	Duarte	California
United States	UF Health Medical Oncology - Davis Cancer Pavilion	Gainesville	Florida
United States	Local Institution - 0001	Hackensack	New Jersey
United States	Local Institution - 0038	Jacksonville	Florida
United States	Local Institution - 0032	New Haven	Connecticut
United States	Local Institution - 0007	New York	New York
United States	Local Institution - 0005	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	UPMC	Pittsburgh	Pennsylvania
United States	Local Institution - 0002	Portland	Oregon
United States	Local Institution - 0017	Rochester	Minnesota
United States	Local Institution - 0003	Saint Louis	Missouri
United States	Local Institution - 0004	Seattle	Washington
United States	Local Institution - 0036	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Clovis Oncology, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Israel,  Italy,  Netherlands,  Singapore,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) by Investigator	ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.	From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
Primary	Median Duration of Response (DOR)	Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.	From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)
Primary	Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks	The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.	24 weeks after first dose
Secondary	Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.	From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)
Secondary	Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests	The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.	From first dose to 100 days after last dose of study therapy (approximately 30 months)
Secondary	Number of Participants With Laboratory Abnormalities in Specific Liver Tests	The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal	From first dose to 100 days after last dose of study therapy (approximately 30 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form