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

This study is currently recruiting participants.
Verified October 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02996110
First Posted: December 19, 2016
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

Condition Intervention Phase
Advanced Cancer Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • Safety as measured by incidence of AEs (Adverse Events) [ Time Frame: Up to 268 days ]
  • Safety as measured by incidence of SAEs (Serious Adverse Events) [ Time Frame: Up to 268 days ]
  • Tolerability as measured by incidence of AEs [ Time Frame: Up to 268 days ]
  • Tolerability as measured by SAEs [ Time Frame: Up to 268 days ]

Estimated Enrollment: 200
Actual Study Start Date: January 17, 2017
Estimated Study Completion Date: January 18, 2022
Estimated Primary Completion Date: January 17, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

  Contacts and Locations
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 #.

  Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 Submitted: December 15, 2016
First Posted: December 19, 2016
Last Update Posted: October 5, 2017
Last Verified: October 2017

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