Trial of Belzutifan for the Treatment of Various Tumour Types
Research type
Research Study
Full title
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors with HIF-2α related Genetic Alterations
IRAS ID
1003821
Contact name
Vivek Khemka
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2020-005028-13
Research summary
Pheochromocytoma/paraganglioma (PPGL) and pancreatic neuroendocrine tumours (pNET) are rare tumours with no clear standard of care and a very high unmet medical need.
This study is a multi-site, open-label study of belzutifan monotherapy in participants with advanced PPGL or pNET. Approximately 140 participants will be enrolled in the study. The 140 participants will consist of approximately 70 participants with PPGL and 70 participants with pNET. Participants must be at least 12 years old and weigh at least 40kg.
Belzutifan is an experimental drug that has not been approved for use in PPGL/pNET. The trial is being done to test the safety and efficacy of belzutifan.
This phase 2 study will last for approximately 4 years.
The trial has 3 parts:
Screening: Potential participants will visit the trial site at least once to see if they can be in the trial.
Treatment: Participants who are eligible will go on to the treatment phase. Participants will be in the treatment phase as long as it is safe and their cancer is not getting worse. During the study, participants will visit the study site and undergo procedures such as physical examinations, ECGs, blood and urine samples and scans. All participants will take Belzutifan tablets once a day during the treatment phase.
Follow-up: After participants stop taking the trial drug, they will enter the follow-up phase.The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD). It will take place at 5 study centres in UK.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0186
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion