BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition:	Renal Cell Carcinoma
Intervention:	Biological: nivolumab

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study is still on-going.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
198 participants enrolled and 168 were randomized to study drug: 27 were not randomized to a study arm because they no longer met criteria and 3 were not randomized because the participants withdrew consent.

Reporting Groups

	Description
0.3 mg/kg Nivolumab	Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
2.0 mg/kg Nivolumab	Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
10.0 mg/kg Nivolumab	Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons

Participant Flow for 2 periods

Period 1:   Randomized to Enter Treatment Period

	0.3 mg/kg Nivolumab	2.0 mg/kg Nivolumab	10.0 mg/kg Nivolumab
STARTED	60	54	54
COMPLETED	59	54	54
NOT COMPLETED	1	0	0
No longer met criteria	1	0	0

Period 2:   Participants Treated

	0.3 mg/kg Nivolumab	2.0 mg/kg Nivolumab	10.0 mg/kg Nivolumab
STARTED	59	54	54
COMPLETED	0	0	0
NOT COMPLETED	59	54	54
Continuing Treatment	6	2	4
Disease Progression	49	40	41
Study Drug Toxicity	2	7	4
Death	0	1	0
Adverse Event	1	2	4
Withdrawal by Subject	1	2	1

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Randomized participants were included.

Reporting Groups

	Description
0.3 mg/kg Nivolumab	Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
2.0 mg/kg Nivolumab	Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
10.0 mg/kg Nivolumab	Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
Total	Total of all reporting groups

Baseline Measures

	0.3 mg/kg Nivolumab	2.0 mg/kg Nivolumab	10.0 mg/kg Nivolumab	Total
Overall Participants Analyzed; [Units: Participants]	60	54	54	168
Age; [Units: Years]; Mean (Standard Deviation)	61.0 (8.82)	60.8 (8.23)	60.6 (9.61)	60.8 (8.85)
Age, Customized; [Units: Participants]
Less than (<) 65 years	37	41	35	113
65 to < 75 years	20	9	15	44
Greater than, equal to (>=)75 years	3	4	4	11
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	19 31.7%	14 25.9%	14 25.9%	47 28.0%
Male	41 68.3%	40 74.1%	40 74.1%	121 72.0%

  Outcome Measures

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1. Primary:

Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]

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2. Secondary:

Objective Response Rate (ORR) at Primary Endpoint- Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]

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3. Secondary:

Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ]

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4. Secondary:

Median Overall Survival in Months at Interim Data Cut-off - Randomized Population [ Time Frame: From Randomization to approximately 4 years post randomization ]

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5. Secondary:

Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population [ Time Frame: From Randomization to approximately 4 years post randomization ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

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.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: 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
e-mail: Clinical.Trials@bms.com

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

George S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775.

Motzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol. 2015 May 1;33(13):1430-7. doi: 10.1200/JCO.2014.59.0703. Epub 2014 Dec 1.

George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. Review.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01354431 History of Changes
Other Study ID Numbers:	CA209-010
First Submitted:	May 10, 2011
First Posted:	May 16, 2011
Results First Submitted:	September 8, 2015
Results First Posted:	October 20, 2015
Last Update Posted:	January 26, 2018