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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996110
Recruitment Status : Completed
First Posted : December 19, 2016
Results First Posted : December 19, 2022
Last Update Posted : December 19, 2022
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)
Actual Enrollment : 182 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 : February 2, 2017
Actual Primary Completion Date : November 23, 2021
Actual Study Completion Date : November 23, 2021

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
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Ipilimumab
Specified Dose on Specified Days
Other Names:
  • BMS-734016
  • Yervoy
Experimental: Nivolumab + Relatlimab
Nivolumab + Relatlimab
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Biological: Relatlimab
Specified Dose on Specified Days
Other Name: BMS-986016
Experimental: Nivolumab + BMS-986205
Nivolumab + BMS-986205
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-986205
Specified Dose on Specified Days
Experimental: Nivolumab + BMS-813160
Nivolumab + BMS-813160 (CCR2/5 dual antagonist)
 Biological: Nivolumab
Specified Dose on Specified Days
Other Names:
  • Opdivo
  • BMS-936558

Drug: BMS-813160
Specified Dose on Specified Days


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) Per Investigator [ Time Frame: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (assessed up to approximately 247 weeks) ]

    ORR is percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR).

    BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first.

    For participants who received re-treatment or were re-randomized, the re-treatment and re-randomized therapies were considered subsequent anticancer therapy.

    CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to <10 mm.

    PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment.

    CR+PR, confidence interval based on Clopper and Pearson method.


  2. Median Duration of Response (DOR) Per Investigator [ Time Frame: From first dose to the date of first documented disease progression or death due to any cause (assessed from an average of 22 weeks up to approximately 247 weeks) ]

    Duration of Response is defined as the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause (death occurring after re-treatment or randomization to new combination treatment was not considered), whichever occurred first.

    Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Median computed using Kaplan -Meier method


  3. Progression Free Survival Rate (PFSR) at 24 Weeks. [ Time Frame: 24 weeks after first treatment dose. ]

    The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.

    Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula



Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  2. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) ]
    Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization

  3. Number of Participants With Adverse Events (AEs) Leading to Discontinuation [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

  4. Number of Participants Who Died [ Time Frame: From first dose to 100 days after last dose of study therapy (assessed up to approximately 118 weeks) ]
    Death is defined as the cessation of all vital functions of the body including the heartbeat, brain activity (including the brain stem), and breathing.

  5. Number of Participants With Abnormal Thyroid Test Results - Track 1 [ Time Frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks) ]
    The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.

  6. Number of Participants With Abnormal Thyroid Test Results - Track 2 [ Time Frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks) ]
    The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal

  7. Number of Participants With Abnormal Hepatic Test Results - Track 1 [ Time Frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks) ]
    The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal

  8. Number of Participants With Abnormal Hepatic Test Results - Track 2 [ Time Frame: From first dose to 30 days after last dose of study therapy (approximately 108 weeks) ]
    The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal


Eligibility Criteria
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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.


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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

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 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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol and Statistical Analysis Plan  [PDF] January 11, 2022

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: December 19, 2022
Last Update Posted: December 19, 2022
Last Verified: November 2022

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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
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Nivolumab
Ipilimumab
Relatlimab
Linrodostat
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors