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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2023-09-27

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is an open-label Phase 2 study that will be conducted with a 2-stage design.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-3795

Participants receive 800 mg MK-3795 orally twice daily. Participants may continue to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.

Group Type EXPERIMENTAL

MK-3795

Intervention Type DRUG

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

Interventions

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MK-3795

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

Intervention Type DRUG

Other Intervention Names

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PT2385, PT-2385

Eligibility Criteria

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Inclusion Criteria

* Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems
* Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration

Exclusion Criteria

* Has had prior radiotherapy or systemic anti cancer therapy for ccRCC (includes anti-vascular endothelial growth factor (VEGF) therapy or any systemic investigational anti cancer agent)
* Has a prior or concomitant non-VHL disease-associated invasive malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the participant has remained disease free for more than 2 years
* Has any history of metastatic disease
* Has had radiotherapy to any non-ccRCC site within 4 weeks prior to entering the study or has not recovered from adverse events (AE)
* Has had any surgical procedure for VHL disease or any major surgical procedure completed within 4 weeks prior to entering the study or has any surgical lesions from recent major surgical procedures that are not well healed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No