CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
MK-3795drug
Likely dose
MK-3795 800 mg twice daily (four 200 mg oral tablets twice daily)AI-extracted
Key inclusion· 2
  • ✓Diagnosis of von Hippel Lindau disease confirmed by germline VHL alteration
  • ✓At least 1 measurable ccRCC tumor with all lesions ≤3.0 cm based on imaging
Key exclusion· 5
  • ✕Prior radiotherapy or systemic anti-cancer therapy for ccRCC, including VEGF inhibitors or investigational agents
  • ✕Any history of metastatic disease
  • ✕Prior or concomitant non-VHL invasive malignancy except adequately treated skin cancers, cervical carcinoma in situ, or disease-free >2 years
  • ✕Radiotherapy to non-ccRCC site within 4 weeks or incomplete recovery from adverse events

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03108066
NCT03108066Phase 2Completed
CompareCT.gov

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

Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Apr 11, 2017·Updated Sep 24, 2024

In Brief

A Phase 2 clinical trial evaluating MK-3795 for VHL Gene Mutation and 10 related conditions. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVHL 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
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 11, 2017
Enrollment StartApr 24, 2017
Primary CompletionAug 30, 2023
Study CompletionSep 27, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.2 years ago

Interventions

MK-3795drug

800 mg twice daily (four 200 mg oral tablets twice daily)