Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01472081 · ClinicalTrials.gov registry record · Phase 1
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)
A Phase 1 study of Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 194
- Enrollment target
- 14
- Study locations
NCT01472081: Completed Phase 1 study of Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, sponsored by Bristol-Myers Squibb.
NCT01472081 is a Phase 1 study of Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 194 participants, below the 241-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (20% lower). The trial reports 14 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01472081, a Phase 1 study of Renal Cell Carcinoma and Clear-cell Metastatic Renal Cell Carcinoma, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 194 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.
Primary Outcome
Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or
Conditions Studied
Interventions
- DRUG Sunitinib
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- BIOLOGICAL Pazopanib
Study Locations (14)
Alberta
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute - Edmonton
California
- City Of Hope - Duarte
Maryland
- Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins - Baltimore
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
New York
- Memorial Sloan Kettering Nassau - New York
North Carolina
- Blumenthal Cancer Center - Charlotte
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-02-09 |
| Est. Completion | 2021-06-03 |
| Phase | Phase 1 |
What the finished NCT01472081 record still lists
NCT01472081 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 241-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Sunitinib is the first listed.
NCT01472081 lists 14 locations in 13 states (Alberta, California, Maryland).
Frequently Asked Questions
What is clinical trial NCT01472081 about?
NCT01472081 is a clinical study titled "Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)". The purpose is to determine the safety, effectiveness and best dose to use when giving Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of metastatic renal cell carcinoma.
What is the current status of trial NCT01472081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 194 participants. The study started on 2012-02-09. Estimated completion is 2021-06-03.
What conditions does trial NCT01472081 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Clear-cell Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT01472081?
The interventions under investigation include: Sunitinib (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Pazopanib (BIOLOGICAL).
Who is sponsoring clinical trial NCT01472081?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01472081 being conducted?
This trial has 14 study locations across California, Maryland, Massachusetts, New Hampshire, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01472081's enrollment target sits among peer trials
194 31st of 121 higher than 91 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
RECRUITING · Phase 1
-
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
RECRUITING · Phase 1
-
A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours
RECRUITING · Phase 1
-
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
RECRUITING · Phase 1
-
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03593759 · 194 participants · Phase 3
Cardiac Sarcoidosis Randomized Trial
- NCT05053152 · 194 participants · Phase 2
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
- NCT05156112 · 194 participants · NA
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
- NCT05351424 · 194 participants · NA
AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI