Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04987203 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
A Phase 3 study of Renal Cell Carcinoma, sponsored by AVEO Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 343
- Enrollment target
- 20
- Study locations
NCT04987203: Active Phase 3 study of Renal Cell Carcinoma, sponsored by AVEO Pharmaceuticals.
NCT04987203 is a Phase 3 study of Renal Cell Carcinoma that is active but no longer recruiting, run by AVEO Pharmaceuticals. The registered enrollment target is 343 participants, above the 240-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04987203, a Phase 3 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by AVEO Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 343 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).
Primary Outcome
Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease \[PD\], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Tivozanib
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Chao Family Comprehensive Cancer Center, UC Irvine - Irvine
- University of California San Diego - La Jolla
- Leland Stanford Junior University - Redwood City
- Kaiser Permanente Riverside Medical Center - Riverside
Maryland
- University of Maryland Medical Center-Greenebaum Cancer Ctr - Baltimore
- John Hopkins Medicine - Hematology/oncology - Baltimore
- Maryland Oncology Hematology - Clinton
Florida
- Florida Cancer Specialists & Res Inst - Fort Myers
- Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location - St. Petersburg
Colorado
- US Oncology - Rocky Mountain Cancer Centers - Midtown - Denver
Kansas
- The University of Kansas Cancer Center - Westwood
Kentucky
- University of Kentucky UK Markey Cancer Center - Lexington
Louisiana
- Tulane Cancer Center Clinic - Oncology - New Orleans
Massachusetts
- Dana-Farber Cancer Institute - Medicine - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2021-09-09 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 3 |
What the registry record for NCT04987203 still lists
NCT04987203 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, above the 240-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04987203 names 20 study sites across 13 states, led by California, Maryland, Florida.
Frequently Asked Questions
What is clinical trial NCT04987203 about?
NCT04987203 is a clinical study titled "Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma". This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).
What is the current status of trial NCT04987203?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2021-09-09. Estimated completion is 2025-12-30.
What conditions does trial NCT04987203 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT04987203?
The interventions under investigation include: Nivolumab (DRUG), Tivozanib (DRUG).
Who is sponsoring clinical trial NCT04987203?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04987203 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kansas, Kentucky. 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 NCT04987203's enrollment target sits among peer trials
343 22nd of 121 higher than 100 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 of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
RECRUITING · Phase 3
-
Dynamic Contrast Enhancement Computed Tomography for Evaluating Tumor Perfusion in Patients With Metastatic Renal Cell Carcinoma Receiving Targeted Therapies: Renal Cell Carcinoma (RCC) Scramble
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
ACTIVE NOT RECRUITING · Phase 3
-
Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
-
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
ACTIVE NOT RECRUITING · Phase 3
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
- NCT06733363 · 344 participants · Phase 2
A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscle Invasive Bladder Cancer
- NCT07179380 · 344 participants · Phase 3
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
- NCT07304024 · 344 participants · Phase 1
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
- NCT05283850 · 342 participants · Phase 2
Surviving PEA in Roanoke (SPEAR) Study
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