Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL) or Pancreatic Neuroendocrine Tumour (pNET) (MK-6482-015)

Official 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) or Pancreatic Neuroendocrine Tumour (pNET)

Summary:

This is a study to evaluate the efficacy and safety of Belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL) or pancreatic neuroendocrine tumour (pNET). The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Trial Description

Primary Outcome:

• Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)

• Duration of Response (DOR) as Assessed by BICR
• Time to Response (TTR) as Assessed by BICR
• Disease Control Rate (DCR) as Assessed by BICR
• Progressive Free Survival (PFS) as Assessed by BICR
• Overall Survival (OS)
• Number of Participants Experiencing Adverse Events (AEs)
• Number of Participants Discontinuing Study Drug due to an AE

View this trial on ClinicalTrials.gov