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 :
Completed
First Posted : December 19, 2016
Results First Posted : December 19, 2022
Last Update Posted : December 19, 2022
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Advanced Cancer |
Interventions |
Biological: Nivolumab Biological: Ipilimumab Biological: Relatlimab Drug: BMS-986205 Drug: BMS-813160 |
Enrollment | 182 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Of the 178 participants that were treated, 60 were initially randomized to Track 1 and 118 were initially randomized to Track 2. The 152 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 35 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2. |
Arm/Group Title | Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Arm 3: Nivolumab Plus BMS-986205 | Arm 4: Nivolumab Plus BMS-813160 150 mg | Arm 5: Nivolumab Plus BMS-813160 300mg |
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Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. |
Period Title: Pre-Treatment | |||||
Started [1] | 65 | 56 | 26 | 17 | 18 |
Completed [2] | 65 | 55 | 25 | 17 | 16 |
Not Completed | 0 | 1 | 1 | 0 | 2 |
Reason Not Completed | |||||
Other Reasons | 0 | 1 | 0 | 0 | 1 |
Participant Withdrew Consent | 0 | 0 | 1 | 0 | 1 |
[1]
Initial Randomization
[2]
Continuing Into Treatment Period
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Period Title: Track 1 | |||||
Started | 30 | 30 | 0 | 0 | 0 |
Re-Randomized to Track 2 | 5 | 6 | 0 | 0 | 0 |
Completed | 7 | 8 | 0 | 0 | 0 |
Not Completed | 23 | 22 | 0 | 0 | 0 |
Reason Not Completed | |||||
Disease Progression | 15 | 17 | 0 | 0 | 0 |
Adverse Event Unrelated to Study Drug | 1 | 1 | 0 | 0 | 0 |
Study Drug Toxicity | 5 | 3 | 0 | 0 | 0 |
Participant Requested to Discontinue Study Treatment | 1 | 0 | 0 | 0 | 0 |
Administrative Reason by Sponsor | 0 | 1 | 0 | 0 | 0 |
Participant no Longer Met Study Criteria | 1 | 0 | 0 | 0 | 0 |
Period Title: Track 2 | |||||
Started | 46 | 32 | 31 | 21 | 22 |
No Pre-Randomization | 35 | 25 | 25 | 17 | 16 |
Re-Randomized From Track 1 Nivolumab + Relatlimab | 2 | 0 | 2 | 1 | 1 |
Re-Randomized From Track 1 Nivolumab + Ipilimumab | 0 | 3 | 1 | 1 | 0 |
Re-Randomized From Track 2 Nivolumab + Relatlimab | 7 | 0 | 2 | 0 | 1 |
Re-Randomized From Track 2 Nivolumab + BMS986205 | 2 | 2 | 0 | 1 | 2 |
Previously Un-Treated But Re-Randomized | 0 | 0 | 0 | 1 | 0 |
Re-Randomized From Track 2 Nivolumab + Ipilimumab | 0 | 2 | 1 | 0 | 2 |
Completed | 4 | 3 | 1 | 1 | 1 |
Not Completed | 42 | 29 | 30 | 20 | 21 |
Reason Not Completed | |||||
Disease Progression | 33 | 26 | 19 | 16 | 15 |
Adverse Event Unrelated to Study Drug | 4 | 0 | 0 | 1 | 1 |
Death | 0 | 0 | 1 | 0 | 1 |
Study Drug Toxicity | 4 | 1 | 4 | 1 | 0 |
Participant Requested to Discontinue Study Treatment | 0 | 0 | 2 | 1 | 2 |
Participant Withdrew Consent | 1 | 2 | 3 | 1 | 1 |
Other Reasons | 0 | 0 | 1 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Arm 1: Nivolumab Plus Ipilimumab (BMS-734016) | Arm 2: Nivolumab Plus Relatlimab (BMS-986016) | Arm 3: Nivolumab Plus BMS-986205 | Arm 4: Nivolumab Plus BMS-813160 150 mg | Arm 5: Nivolumab Plus BMS-813160 300mg | Total | |
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Nivolumab was administered at 3 mg/kg via IV infusion followed by ipilimumab 1 mg/kg administered IV over approximately 30 minutes every 3 weeks for 4 doses. Six weeks after the last dose of combination study treatment nivolumab 480 mg was administered IV over approximately 30 minutes every 4 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered at a flat dose of 240 mg via IV infusion every 2 weeks followed by 80 mg BMS-986016 administered IV approximately 60 minutes every 2 weeks until completion of approximately 2 years of study treatment, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg via IV infusion every 4 weeks, and BMS-986205 taken orally at a dose of 100 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 150 mg daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Nivolumab was administered as a flat dose of 480 mg by IV infusion every 4 weeks combined with oral BMS-813160, 300 mg twice daily for up to 2 years, clinical deterioration suggesting that no further benefit from study treatment is likely, intolerable toxicity, meeting of criteria for discontinuation of study treatment, or withdrawal of consent, whichever occurred first. | Total of all reporting groups | |
Overall Number of Baseline Participants | 65 | 56 | 26 | 17 | 18 | 182 | |
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Arms 1 and 2 take into account both Track 1 and Track 2 participants as well as those rerandomized to the respective arms in Track 2.
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Age, Categorical
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 56 participants | 26 participants | 17 participants | 18 participants | 182 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
40 61.5%
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41 73.2%
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16 61.5%
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12 70.6%
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11 61.1%
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120 65.9%
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>=65 years |
25 38.5%
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15 26.8%
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10 38.5%
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5 29.4%
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7 38.9%
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62 34.1%
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[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 56 participants | 26 participants | 17 participants | 18 participants | 182 participants | |
Female |
14 21.5%
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16 28.6%
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6 23.1%
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4 23.5%
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9 50.0%
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49 26.9%
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Male |
51 78.5%
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40 71.4%
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20 76.9%
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13 76.5%
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9 50.0%
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133 73.1%
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[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
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Ethnicity (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Track 2 | Number Analyzed | 65 participants | 56 participants | 26 participants | 17 participants | 18 participants | 182 participants |
Hispanic or Latino |
3 4.6%
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2 3.6%
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2 7.7%
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1 5.9%
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0 0.0%
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8 4.4%
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Not Hispanic or Latino |
37 56.9%
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34 60.7%
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19 73.1%
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12 70.6%
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10 55.6%
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112 61.5%
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Unknown or Not Reported |
25 38.5%
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20 35.7%
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5 19.2%
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4 23.5%
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8 44.4%
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62 34.1%
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[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
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Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 65 participants | 56 participants | 26 participants | 17 participants | 18 participants | 182 participants |
White | 62 | 52 | 23 | 14 | 17 | 168 | |
Asian Indian | 1 | 0 | 0 | 0 | 0 | 1 | |
Chinese | 0 | 1 | 0 | 0 | 0 | 1 | |
Asian Other | 1 | 1 | 0 | 0 | 0 | 2 | |
Other | 1 | 2 | 2 | 2 | 0 | 7 | |
Black or African American | 0 | 0 | 1 | 1 | 1 | 3 | |
[1]
Measure Analysis Population Description: The analysis population consists of all participants treated (including those re-randomized) in each Arm.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: | Bristol-Myers Squibb Study Director |
Organization: | Bristol-Myers Squibb |
Phone: | Please Email |
EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02996110 |
Other Study ID Numbers: |
CA018-005 2016-003082-26 ( EudraCT Number ) |
First Submitted: | December 15, 2016 |
First Posted: | December 19, 2016 |
Results First Submitted: | November 18, 2022 |
Results First Posted: | December 19, 2022 |
Last Update Posted: | December 19, 2022 |