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

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.
 
ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Drug: BMS-813160 Phase 2

Study Design
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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 18, 2022
Estimated Study Completion Date : January 18, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Experimental: Nivolumab + BMS-813160
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
 Biological: Nivolumab
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-813160


Outcome Measures
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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 ]

Eligibility Criteria
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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
  • Karnofsky Performance Status (KPS) must be =>70%

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
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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
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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 #.

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

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02996110    
Other Study ID Numbers: CA018-005
2016-003082-26 ( EudraCT Number )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents