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A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC)

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ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to test the effectiveness and safety of various nivolumab combinations compared to nivolumab and ipilimumab in participants with advanced kidney cancer

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Drug: BMS-986205 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Participants With Advanced Renal Cell Carcinoma (FRACTION-RCC)
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : January 17, 2022
Estimated Study Completion Date : January 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Active Comparator: Nivolumab + Ipilimumab
Nivolumab + Ipilimumab
Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Other Names:
  • BMS-734016
  • Yervoy

Experimental: Nivolumab + Relatlimab
Nivolumab + Relatlimab
Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Biological: Relatlimab
Other Name: BMS-986016

Experimental: Nivolumab + BMS-986205
Nivolumab + BMS-986205
Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205



Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
  2. Duration of Response (DOR) [ Time Frame: Up to 24 weeks ]
  3. Progression-free Survival Rate (PFSR) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Safety as measured by incidence of AEs (Adverse Events) [ Time Frame: Up to 2 years ]
  2. Safety as measured by incidence of SAEs (Serious Adverse Events) [ Time Frame: Up to 2 years ]
  3. Tolerability as measured by incidence of AEs [ Time Frame: Up to 2 years ]
  4. Tolerability as measured by SAEs [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Advanced Renal Cell Carcinoma
  • Must have at least 1 lesion with measurable disease
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Patients/subjects with suspected or known central nervous system metastases unless adequately treated
  • Patients/subjects with autoimmune disease
  • Patients/subjects who need daily oxygen therapy

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996110


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
United States, California
Local Institution Withdrawn
San Francisco, California, United States, 94115
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Harriet Kluger, Site 0037    203-500-0834      
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Mayer Fishman, Site 0021    813-745-7559      
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Jigarkumar Parikh, Site 0031    706-721-1206      
United States, Illinois
Rush University Med Ctr Recruiting
Chicago, Illinois, United States, 60612
Contact: Timothy Kuzel, Site 0006    312-942-8004      
United States, Maryland
Sidney Kimmel Cancer Center At Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michael Carducci, Site 0007    410-502-5101      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Toni Choueiri, Site 0001    617-632-4420      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Toni Choueiri, Site 0009    617-643-0975      
United States, Michigan
Karmanos Cancer Center Recruiting
Detroit, Michigan, United States, 48201
Contact: Ulka Vaishampayan, Site 0011         
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: James Hsieh, Site 0008    314-747-1343      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Saby George, Site 0004    716-845-7754      
Columbia University Medical Center (Cumc) Recruiting
New York, New York, United States, 10032
Contact: Emerson Lim, Site 0020         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Chung-Han Lee, Site 0005    646-888-1397      
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Asim Amin, Site 0043         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Edmund Folefac, Site 0014    614-293-7833      
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Christopher Ryan, Site 0018    503-418-9655      
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0002    610-402-1184      
United States, South Carolina
Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Theodore Gourdin, Site 0015    843-792-2306      
United States, Tennessee
Tennessee Oncology, Pc Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell, Site 0025         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Hans Hammers, Site 0013         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Robert Dreicer, Site 0024         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Scott Tykodi, Site 0003    206-288-7763      
Australia, New South Wales
Local Institution Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Site 0032         
Australia, Victoria
Local Institution Recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0033         
Austria
Krankenhaus Der Barmherzigen Schwestern Recruiting
Linz, Austria, 4010
Contact: Wolfgang Loidl, Site 0044    +43732076774445      
Canada, Nova Scotia
Local Institution Withdrawn
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Local Institution Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Site 0038         
Local Institution Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Site 0029         
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0035         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Wilson Miller, Site 0034    51434082226394      
Canada
Local Institution Recruiting
Quebec, Canada, G1R 2J6
Contact: Site 0030         
Israel
Local Institution Recruiting
Haifa, Israel, 3109601
Contact: Site 0023         
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0022         
Italy
IRCCS Istituto Nazionale Tumori Milano Recruiting
Milano, Italy, 20133
Contact: Giuseppe Procopio, Site 0010         
Istituto Nazionale Tumori Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Sandro Pignata, Site 0012         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02996110     History of Changes
Other Study ID Numbers: CA018-005
2016-003082-26 ( EudraCT Number )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs