Phase 2
Completed N=4
MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003)
VHL Gene Mutation · VHL · VHL Syndrome · VHL Gene Inactivation
Source: ClinicalTrials.gov NCT03108066 ↗
Enrolled (actual)
4
Serious AEs
75.0%
Results posted
Sep 2024
Primary outcomePrimary: Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors — 0.0 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors |
0.0 | — |
| SECONDARY Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors |
NA | — |
| SECONDARY Duration of Response (DOR) in VHL Disease-Associated ccRCC Tumors |
— | — |
| SECONDARY Time to Response (TTR) in VHL Disease-Associated ccRCC Tumors |
— | — |
| SECONDARY Overall Response Rate (ORR) in VHL Disease-Associated Non-ccRCC Tumors |
— | — |
| SECONDARY Progression-free Survival (PFS) in VHL Disease-Associated Non-ccRCC Tumors |
— | — |
| SECONDARY Duration of Response (DOR) in VHL Disease-Associated Non-ccRCC Tumors |
— | — |
| SECONDARY Time to Response (TTR) in VHL Disease-Associated Non-ccRCC Tumors |
— | — |
| SECONDARY MK-3795 Plasma Concentration |
NA; 583; 1750; 1480; 2550; 3150 | — |
| SECONDARY MK-3795 Metabolite Plasma Concentration |
NA; 2790; 4530; 3440; 5790; 6360 | — |
| SECONDARY Number of Participants Who Experienced One or More Adverse Events (AEs) |
4 | — |
| SECONDARY Number of Participants Who Discontinued Study Intervention Due to an AE |
2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03108066). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.