Coformulated favezelimab/pembrolizumab: Coformulated favezelimab/pembrolizumab (800 mg/200 mg) IV infusion
Coformulated vibostolimab/pembrolizumab: Coformulated vibostolimab/pembrolizumab (200 mg/200 mg) IV infusion
EV: 1.25 mg/kg IV infusion
Pembrolizumab: 200 mg IV infusion
This study is a substudy being conducted under one pembrolizumab umbrella master study KEYMAKER-U04. The substudy will consist of 2 parts. Part 1 will evaluate the efficacy and safety of coformulated favezelimab/pembrolizumab plus EV and coformulated vibostolimab/pembrolizumab plus EV relative to pembrolizumab plus EV. There will be no comparison of coformulated favezelimab/pembrolizumab plus EV versus coformulated vibostolimab/pembrolizumab plus EV. If ORR and/or DRR are substantially better on coformulated favezelimab/pembrolizumab plus EV and/or coformulated vibostolimab/pembrolizumab plus EV compared with pembrolizumab plus EV, after evaluation of the totality of data, the sponsor might consider Part 2 (expansion) to further characterize the efficacy and safety of the treatment arms under study.
| Facility | City | Region | Status |
|---|---|---|---|
| Moores Cancer Center ( Site 3028) | La Jolla | California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045) | Orange | California | |
| UCSF Medical Center at Mission Bay ( Site 3044) | San Francisco | California | |
| Anschutz Cancer Pavilion ( Site 3017) | Aurora | Colorado | |
| Emory University School of Medicine ( Site 3043) | Atlanta | Georgia | |
| Indiana University Melvin and Bren Simon Cancer Center ( Site 3011) | Indianapolis | Indiana | |
| Dana-Farber Cancer Institute ( Site 3047) | Boston | Massachusetts | |
| Siteman Cancer Center ( Site 3038) | St Louis | Missouri | |
| Icahn School of Medicine at Mount Sinai ( Site 3018) | New York | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 3031) | New York | New York | |
| Duke Cancer Institute ( Site 3027) | Durham | North Carolina | |
| Cleveland Clinic-Taussig Cancer Center ( Site 3036) | Cleveland | Ohio | |
| UPMC Hillman Cancer Center ( Site 3014) | Pittsburgh | Pennsylvania | |
| Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 3041) | Salt Lake City | Utah | |
| Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 3951) | Brisbane | Queensland | |
| Austin Health-Cancer Clinical Trials Centre ( Site 3950) | Heidelberg | Victoria | |
| The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 3105) | Ottawa | Ontario | |
| Sunnybrook Research Institute - Odette Cancer Centre ( Site 3108) | Toronto | Ontario | |
| Princess Margaret Cancer Centre ( Site 3106) | Toronto | Ontario | |
| FALP-UIDO ( Site 3151) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 3155) | Santiago | Region M. de Santiago | |
| ONCOCENTRO APYS-ACEREY ( Site 3158) | Viña del Mar | Valparaiso | |
| Bradford Hill Norte ( Site 3152) | Antofagasta | Chile | |
| CHU de Bordeaux Hop St ANDRE ( Site 3607) | Bordeaux | Aquitaine | |
| Centre Georges François Leclerc-Centre de recherche clinique ( Site 3608) | Dijon | Cote-d Or | |
| Oncopole Claudius Regaud ( Site 3610) | Toulouse | Haute-Garonne | |
| centre hospitalier lyon sud ( Site 3606) | Pierre-Bénite | Rhone | |
| Hôpital Européen Georges Pompidou ( Site 3605) | Paris | France | |
| Rambam Health Care Campus-Oncology Division ( Site 3501) | Haifa | Israel | |
| Rabin Medical Center-Oncology ( Site 3504) | Petah Tikva | Israel | |
| Sheba Medical Center-ONCOLOGY ( Site 3503) | Ramat Gan | Israel | |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 3406) | Naples | Campania | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3405) | Milan | Lombardy | |
| Ospedale San Raffaele-Oncologia Medica ( Site 3403) | Milan | Italy | |
| Maastricht UMC+ ( Site 3304) | Maastricht | Limburg | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 3302) | Amsterdam | North Holland | |
| Erasmus Medisch Centrum-Medical Oncology ( Site 3303) | Rotterdam | South Holland | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3903) | Seoul | South Korea | |
| Asan Medical Center-Department of Oncology ( Site 3901) | Seoul | South Korea | |
| Samsung Medical Center ( Site 3902) | Seoul | South Korea |
+ 7 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 NCT05845814 on ClinicalTrials.gov ↗ ← All trials in the USA