NCT04388852

DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers

DS3201 With Ipilimumab in Patients With Metastatic Aggressive Variant Prostate (AVPC), Urothelial (UC), and Renal Cell (RCC) Carcinomas

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib trial studies the side effects and best dose of DS3201 when given together with and ipilimumab for the treatment of patients with prostate, urothelial, or renal cell cancer that has spread to other places in the body (metastatic). DS3201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DS3201 and ipilimumab may help to control the disease.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and confirm the safety and tolerability of valemetostat (DS3201) given in combination with ipilimumab in patients with metastatic aggressive variant prostate cancers (AVPC), urothelial carcinomas (UC) and renal clear cell carcinomas (RCC). II. To screen for associations between changes in the tumor microenvironment and clinical outcomes. SECONDARY OBJECTIVES: I. To assess the immunologic and molecular effects on tissue samples of participants treated with DS3201 in combination with ipilimumab in patients with metastatic AVPC, UC and RCC. II. To estimate the time to treatment failure (TTF) of patients with metastatic AVPC, UC and RCC treated with DS3201 in combination with ipilimumab. III. To estimate the overall response rate (ORR) of patients with metastatic AVPC, UC and RCC treated with DS3201 in combination with ipilimumab (in patients with AVPC ORR will be reported separately for prostate specific antigen \[PSA\], circulating tumor cells \[CTC\] and measurable and non-measurable disease by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1). OUTLINE: This is a dose-escalation study of valemetostat. Patients receive valemetostat orally (PO) once daily (QD) on days 1-21 and ipilimumab intravenously (IV) over 90 minutes on day 1 of cycles 1 and 3. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up 30 and 60 days after the last valemetostat dose and/or 100 days after the last ipilimumab dose and then every 6 months thereafter.

Conditions

• Aggressive Variant Prostate Carcinoma
• Castration-Resistant Prostate Carcinoma
• Metastatic Clear Cell Renal Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Prostate Carcinoma
• Metastatic Urothelial Carcinoma
• Stage IV Prostate Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab	Given IV
DRUG	Valemetostat	Given PO

Timeline

• Start date: 2020-08-20
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-05-14
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study