Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
An Open Label Phase 2 Study to Evaluate PT2385 for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma
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 patients treated with PT2385.
Status | Completed |
Enrollment | 4 |
Est. completion date | September 27, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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-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 patient 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate (ORR) | Overall response rate (ORR) in VHL disease-associated ccRCC tumors | 4-5 years | |
Secondary | Progression Free Survival (PFS) | Progression free survival (PFS) in VHL disease-associated ccRCC tumors | 4-5 years | |
Secondary | Duration of Response (DOR) | Duration of response (DOR) in VHL disease-associated ccRCC tumors | 4-5 years | |
Secondary | Time to Response (TTR) | Time to response (TTR) in VHL disease-associated ccRCC tumors | 4-5 years | |
Secondary | Number of Participants who Experience One or More Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. | Up to approximately 5 years | |
Secondary | Number of Participants who Discontinue Study Intervention Due to an AE. | An AE is defined as any untoward medical occurrence in a patient regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. | Up to approximately 5 years |
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