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

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

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%

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. ]

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. ]

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. ]

4.  Secondary:

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

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 ]

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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