NCT02935634|CompletedPhase 2ResultsDMCFDA Drug

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

FRACTION-GC

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA018-0032016-002807-24

Study Type

interventional

Target

190

Locations

9 countries

Sites

Timeline

RegisteredOct 2016

StartedNov 2016

CompletionMay 2022

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

190

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2016

Longer than P75 for phase_2

Geographic Reach

9 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

First Submitted

Initial submission to the registry

October 14, 2016

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed

1 month until next milestone

Study Start

First participant enrolled

November 29, 2016

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 9, 2023

Completed

Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

5.4 years

First QC Date

October 14, 2016

Results QC Date

May 9, 2023

Last Update Submit

May 9, 2023

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (3)

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)
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)
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 Outcomes (3)

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
From first dose to 100 days after last dose of study therapy (approximately 30 months)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
From first dose to 100 days after last dose of study therapy (approximately 30 months)

Study Arms (6)

Nivolumab + Ipilimumab

ACTIVE COMPARATOR

Biological: NivolumabBiological: Ipilimumab

Nivolumab + Relatlimab

EXPERIMENTAL

Biological: NivolumabBiological: Relatlimab

Nivolumab + BMS-986205

EXPERIMENTAL

Biological: NivolumabBiological: BMS-986205

Nivolumab + Rucaparib

EXPERIMENTAL

Biological: NivolumabDrug: Rucaparib

Ipilimumab + Rucaparib

EXPERIMENTAL

Biological: IpilimumabDrug: Rucaparib

Nivolumab + Ipilimumab + Rucaparib

EXPERIMENTAL

Biological: NivolumabBiological: IpilimumabDrug: Rucaparib