Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03138512 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,641
- Enrollment target
NCT03138512: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT03138512 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,641 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03138512, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,641 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
Primary Outcome
Disease-Free Survival (DFS) is defined as the time from randomization to development of local disease recurrence (ie, recurrence of primary tumor in situ or occurrence of a secondary renal cell carcinoma (RCC) primary cancer), distance metastasis, or death, whichever came first per Blinded Independent Central Review (BICR) based on Kaplan-Meier estimates.
Interventions
- BIOLOGICAL nivolumab
- BIOLOGICAL ipilimumab
- DRUG nivolumab placebo
- DRUG ipilimumab placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,641 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2024-02-01 |
| Phase | Phase 3 |
What the finished NCT03138512 record still lists
NCT03138512 is an interventional study that assigns participants to a tested intervention. Its 1,641 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (113% higher).
The record links to 0 conditions, and to 4 interventions - of which nivolumab is the first listed.
NCT03138512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03138512 about?
NCT03138512 is a clinical study titled "A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a Kidney". The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.
What is the current status of trial NCT03138512?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,641 participants. The study started on 2017-07-07. Estimated completion is 2024-02-01.
What interventions are being tested in trial NCT03138512?
The interventions under investigation include: nivolumab (BIOLOGICAL), ipilimumab (BIOLOGICAL), nivolumab placebo (DRUG), ipilimumab placebo (DRUG).
Who is sponsoring clinical trial NCT03138512?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03138512's enrollment target sits among peer trials
1,641 141st of 2000 higher than 1,860 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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
- NCT04510129 · 1,650 participants
A Multicenter Cancer Biospecimen Collection Study
- NCT05612750 · 1,650 participants · NA
Comparative Effectiveness of Online 8-session CBT vs. 1-Session Empowered Relief for Chronic Pain - The PROGRESS Study
- NCT06215716 · 1,650 participants · Phase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
- NCT07046260 · 1,650 participants
Prospective Study to Assess a Diagnostic Aid for Cancer
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