Pembrolizumab: Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan: Belzutifan 120 mg administered QD via oral tablet
Pembrolizumab/Quavonlimab: Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Lenvatinib: Lenvatinib 20 mg administered QD via oral capsule
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Alabama at Birmingham ( Site 0010) | Birmingham | Alabama | |
| UC San Diego ( Site 0050) | La Jolla | California | |
| Cedars Sinai Medical Center ( Site 0027) | Los Angeles | California | |
| University of California Irvine ( Site 0029) | Orange | California | |
| UCLA Hematology Oncology Santa Monica ( Site 0048) | Santa Monica | California | |
| Hartford Hospital ( Site 0024) | Hartford | Connecticut | |
| Advent Health Hematology & Oncology ( Site 0003) | Orlando | Florida | |
| University Cancer & Blood Center, LLC ( Site 0057) | Athens | Georgia | |
| Emory University Winship Cancer Institute ( Site 0012) | Atlanta | Georgia | |
| Rush University Medical Center ( Site 0040) | Chicago | Illinois | |
| Parkview Cancer Institute ( Site 0088) | Fort Wayne | Indiana | |
| Norton Cancer Institute - St. Matthews ( Site 0065) | Louisville | Kentucky | |
| Ochsner Medical Center ( Site 0049) | New Orleans | Louisiana | |
| New England Cancer Specialists ( Site 0082) | Scarborough | Maine | |
| Massachusetts General Hospital ( Site 0094) | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center ( Site 0089) | Boston | Massachusetts | |
| Dana Farber Cancer Institute ( Site 0093) | Boston | Massachusetts | |
| Lahey Hospital & Medical Center ( Site 0090) | Burlington | Massachusetts | |
| Henry Ford Hospital ( Site 0038) | Detroit | Michigan | |
| Cancer & Hematology Centers of Western Michigan ( Site 0018) | Grand Rapids | Michigan | |
| HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005) | Saint Louis Park | Minnesota | |
| Regions Hospital ( Site 0095) | Saint Paul | Minnesota | |
| University of Mississippi Medical Center ( Site 0037) | Jackson | Mississippi | |
| Dartmouth Hitchcock Medical Center ( Site 0075) | Lebanon | New Hampshire | |
| Roswell Park Cancer Institute ( Site 0032) | Buffalo | New York | |
| R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013) | Lake Success | New York | |
| Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055) | New York | New York | |
| Oregon Health & Science University ( Site 0071) | Portland | Oregon | |
| Ralph H. Johnson VA Center ( Site 0073) | Charleston | South Carolina | |
| University of Tennessee Medical Center Knoxville ( Site 0019) | Knoxville | Tennessee | |
| Vanderbilt University Medical Center ( Site 0069) | Nashville | Tennessee | |
| UTSW Medical Center ( Site 0015) | Dallas | Texas | |
| Central Washington Health Services Association d/b/a Confluence Health ( Site 0061) | Wenatchee | Washington | |
| Liverpool Hospital ( Site 4006) | Liverpool | New South Wales | |
| Macquarie University ( Site 4007) | Macquarie University | New South Wales | |
| Lyell McEwin Hospital ( Site 4004) | Elizabeth Vale | South Australia | |
| Monash Health ( Site 4008) | Clayton | Victoria | |
| Fiona Stanley Hospital ( Site 4009) | Murdock | Western Australia | |
| Oncocentro Ceara ( Site 0309) | Fortaleza | Ceará | |
| Centro de Pesquisas Clinicas em Oncologia ( Site 0306) | Cachoeiro de Itapemirim | Espírito Santo |
+ 222 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04736706 on ClinicalTrials.gov ↗ ← All trials in the USA