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

NCT03108066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-09-24

Study results available
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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.

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

DRUG

MK-3795

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2023-08-30
Completion
2023-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108066 on ClinicalTrials.gov