A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)

Unresectable or Metastatic Melanoma Clinical Trial

Official title:

A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721746
• Other study ID #: CA209-037
• Secondary ID: 2012-001828-35
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2012
• Est. completion date: December 29, 2020

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: December 29, 2020
• Est. primary completion date: February 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Men & women = 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

• Histologically confirmed Stage III (unresectable)/Stage IV melanoma

• Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

• Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens

• Pre-treatment fresh core, excision or punch tumor biopsy

• Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available

Exclusion Criteria:

• Any treatment in a BMS-936558 (Nivolumab) trial

• Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration

• Active, known or suspected autoimmune disease

• Unknown BRAF status

• Active brain metastasis or leptomeningeal metastasis

• Ocular melanoma

• Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)

Related Conditions & MeSH terms

• Melanoma
• Unresectable or Metastatic Melanoma

Intervention

Biological:
• BMS-936558

Drug:
• Dacarbazine

• Carboplatin

• Paclitaxel

Locations

Country	Name	City	State
Austria	Local Institution	Innsbruck
Austria	Local Institution	Wien
Belgium	Local Institution	Brussels
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Edegem
Belgium	Local Institution	Leuven
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Rio de Janeiro
Brazil	Local Institution	Sao Paulo
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUM	Montreal	Quebec
Canada	Sir Mortimer B Davis - Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense
France	Local Institution	Clermont Ferrand
France	Local Institution	Lille Cedex
France	Hopital La Timone	Marseille
France	Local Institution	Nantes Cedex 01
France	Local Institution	Nice
France	Local Institution	Paris
France	Local Institution	Pierre Benite
France	Local Institution	Villejuif
Germany	Local Institution	Buxtehude
Germany	Local Institution	Dresden
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt am Main
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kiel
Germany	Local Institution	Luebeck
Germany	Local Institution	Magdeburg
Germany	Local Institution	Munich
Germany	Local Institution	Tubingen
Germany	Local Institution	Wuerzburg	Bayern
Israel	Local Institution	Jerusalem
Israel	Local Institution	Ramat Gan
Italy	Local Institution	Bari
Italy	Local Institution	Bergamo
Italy	Local Institution	Genova
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Roma
Italy	Local Institution	Siena
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Maastricht
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Pamplona
Spain	Local Institution	Valencia
Switzerland	Local Institution	Lausanne
Switzerland	Local Institution	Zuerich
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Newcastle Upon Tyne	Tyne And Wear
United Kingdom	Local Institution	Oxford	Oxfordshire
United Kingdom	Local Institution	Southampton	Hampshire
United States	Network Office of Research and Innovation	Allentown	Pennsylvania
United States	St. Luke'S Health System	Allentown	Pennsylvania
United States	University Of Michigan Health System	Ann Arbor	Michigan
United States	Winship Cancer Institute	Atlanta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University Hospitals	Cleveland	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	UCSD Moores Cancer Center	La Jolla	California
United States	The Angeles Clinic & Research Institute	Los Angeles	California
United States	University Of California - Los Angeles	Los Angeles	California
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Allina Health	Minneapolis	Minnesota
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	MSKCC Clinical Laboratory at Nassau	New York	New York
United States	NYU Clinical Cancer Center	New York	New York
United States	Orlando Health, Inc	Orlando	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Providence Oncology And Hematology	Portland	Oregon
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	San Francisco Oncology Associates	San Francciso	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1	From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Primary	Overall Survival (OS)	Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.	Up to 96 months
Secondary	Progression Free Survival (PFS)	Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.	From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
Secondary	Objective Response Rate (ORR) by Baseline PD-L1 Expression	Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.	From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
Secondary	Overall Survival (OS) by PD-L1 Positive	Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	Up to 96 months
Secondary	Overall Survival (OS) by PD-L1 Negative	Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.	Up to 96 months
Secondary	Mean Change From Baseline in Health-related Quality of Life (HRQoL)	Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.; Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.; A 10 point difference on a 100 point scale between treatments was considered clinically significant.	From Baseline (Day1) to second Follow-Up (Up to 96 months)

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