Clinical Trial: NCT03414983 - My Cancer Genome

NCT03414983

Description:

This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).

Related Conditions:

Colorectal Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

URL:

https://clinicaltrials.gov/show/NCT03414983

Trial Eligibility

Document

Title

Brief Title: An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread
Official Title: An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer

Clinical Trial IDs

ORG STUDY ID: CA209-9X8
SECONDARY ID: 2017-003662-27
NCT ID: NCT03414983

Conditions

Colorectal Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	BMS-936558, Opdivo	Arm A
Oxaliplatin		Arm A
Leucovorin	Calcium Folinate	Arm A
Fluorouracil		Arm A
Bevacizumab	Avastin	Arm A

Purpose

Trial Arms

Name	Type	Description	Interventions
Arm A	Experimental	Nivo + SOC	Nivolumab Oxaliplatin Leucovorin Fluorouracil Bevacizumab
Arm B	Active Comparator	SOC	Oxaliplatin Leucovorin Fluorouracil Bevacizumab

Eligibility Criteria

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed metastatic colorectal cancer, not amenable to curative
             resection

          -  No prior chemotherapy for metastatic colorectal cancer

          -  ECOG Performance Status of 0-1

          -  Ability to provide adequate tissue sample

        Exclusion Criteria:

          -  Patients with clinically relevant medical history, including autoimmune disease,
             cardiovascular disease, hepatic disease or bleeding disorders

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways

          -  Any positive test result for hepatitis B virus or hepatitis C virus indicating
             presence of virus

        Other protocol defined inclusion/exclusion criteria could apply

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Progression Free Survival (PFS)
Time Frame:	Approximately 28 months
Safety Issue:
Description:	assessed by a Blinded Independent Central Review Committee (BICR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Measure:	Objective Response Rate (ORR)
Time Frame:	Approximately 28 months
Safety Issue:
Description:	assessed by a BICR per RECIST v1.1

Measure:	Disease Control Rate (DCR)
Time Frame:	Approximately 28 months
Safety Issue:
Description:	assessed by a BICR per RECIST v1.1

Measure:	Duration of Response (DoR)
Time Frame:	Approximately 28 months
Safety Issue:
Description:	assessed by a BICR per RECIST v1.1

Measure:	Time to Response (TTR)
Time Frame:	Approximately 28 months
Safety Issue:
Description:	assessed by a BICR per RECIST v1.1

Measure:	Overall Survival (OS)
Time Frame:	Approximately 28 months
Safety Issue:
Description:

Measure:	Number of Adverse Events ( AEs)
Time Frame:	Approximately 28 months
Safety Issue:
Description:

Measure:	Number of Serious Adverse Events ( SAEs)
Time Frame:	Approximately 28 months
Safety Issue:
Description:

Measure:	Number of deaths
Time Frame:	Approximately 28 months
Safety Issue:
Description:

Measure:	Number of clinical abnormalities
Time Frame:	Approximately 28 months
Safety Issue:
Description:

Details

Phase:	Phase 2/Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

July 15, 2020

Clinical Trials /

An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread