NCT03108066

MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003)

An Open Label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the overall response rate (ORR) of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC) tumors in VHL participants treated with MK-3795.

Detailed description

This open-label Phase 2 study will evaluate the efficacy, safety, PK, and PD of MK-3795 in participants with VHL disease who have at least 1 measurable VHL disease-associated ccRCC tumor (as defined by RECIST 1.1). MK-3795 will be administered orally and treatment will be continuous. Changes in VHL disease-associated non-ccRCC tumors will also be evaluated.

Conditions

• VHL Gene Mutation
• VHL
• VHL Syndrome
• VHL Gene Inactivation
• Von Hippel
• Von Hippel-Lindau Disease
• Von Hippel's Disease
• Von Hippel-Lindau Syndrome, Modifiers of
• Clear Cell Renal Cell Carcinoma
• Clear Cell RCC
• ccRCC

Interventions

Type	Name	Description
DRUG	MK-3795	800 mg twice daily (four 200 mg oral tablets twice daily)

Timeline

• Start date: 2017-04-24
• Primary completion: 2023-08-30
• Completion: 2023-09-27
• First posted: 2017-04-11
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study