A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer - Clinical Trial for Advanced Gastric Cancer | NCT02935634

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

Relatlimab

BMS-986205

Rucaparib

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Arm Label

Nivolumab + Ipilimumab

Nivolumab + Relatlimab

Nivolumab + BMS-986205

Nivolumab + Rucaparib

Ipilimumab + Rucaparib

Nivolumab + Ipilimumab + Rucaparib

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

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.

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.

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

Full Information

NCT ID

NCT02935634

First Posted

October 14, 2016

Last Updated

May 9, 2023

Sponsor

Bristol-Myers Squibb

Collaborators

Clovis Oncology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02935634

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 29, 2016 (Actual)

Primary Completion Date

May 11, 2022 (Actual)

Study Completion Date

May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Clovis Oncology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab + Ipilimumab

Arm Type

Active Comparator

Arm Title

Nivolumab + Relatlimab

Arm Type

Experimental

Arm Title

Nivolumab + BMS-986205

Arm Type

Experimental

Arm Title

Nivolumab + Rucaparib

Arm Type

Experimental

Arm Title

Ipilimumab + Rucaparib

Arm Type

Experimental

Arm Title

Nivolumab + Ipilimumab + Rucaparib

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy, BMS-734016

Intervention Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

Relatlimab

Other Intervention Name(s)

BMS-986016

Intervention Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

BMS-986205

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Rucaparib

Other Intervention Name(s)

Rubraca

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) by Investigator

Description

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.

Time Frame

From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)

Title

Median Duration of Response (DOR)

Description

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.

Time Frame

From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)

Title

Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks

Description

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.

Time Frame

24 weeks after first dose

Secondary Outcome Measure Information:

Title

Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death

Description

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.

Time Frame

From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)

Title

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

Description

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.

Time Frame

From first dose to 100 days after last dose of study therapy (approximately 30 months)

Title

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

Description

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

Time Frame

From first dose to 100 days after last dose of study therapy (approximately 30 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Local Institution - 0020

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

University Of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Local Institution - 0032

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 0036

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

UF Health Medical Oncology - Davis Cancer Pavilion

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Local Institution - 0038

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Local Institution - 0006

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Local Institution - 0017

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Local Institution - 0003

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Local Institution - 0001

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Local Institution - 0007

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0002

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Local Institution - 0005

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Local Institution - 0004

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0035

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Local Institution - 0033

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Local Institution

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Local Institution - 0025

City

Toronto,

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Local Institution - 0021

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0039

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Local Institution - 0043

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Local Institution

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Local Institution

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Local Institution - 0014

City

Milan

State/Province

Lombardia

ZIP/Postal Code

20141

Country

Italy

Facility Name

IRCCS Istituto Nazionale Tumori Milano

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Local Institution

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Local Institution - 0050

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Local Institution - 0041

City

Chur

State/Province

Graubünden (de)

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Local Institution - 0042

City

Zuerich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

Investigator Inquiry Form

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

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

Advanced Gastric Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial