NCT04620603

Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study of combination low dose rate brachytherapy (LDR) added to standard of care (SOC) immunotherapy in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer.

Detailed description

The purpose of this study is to evaluate the effect of combining LDR with immune checkpoint inhibition in stage III and IV melanoma, stage IV renal call cancer, and stage IV urothelial cancer. This involves the addition of a treatment called brachytherapy to SOC immunotherapy. Brachytherapy is a form of radiation therapy where radioactive pellets are placed within a tumor to temporarily irradiate the tumor at a low level. This is the first time that this combination (immunotherapy and brachytherapy) has been used in humans. The objectives of this study are to evaluate the effect of combining LDR with immunotherapy, determine safety and feasibility, generate a toxicity profile, evaluate response, and overall survival.

Conditions

• Cutaneous Malignant Melanoma
• Renal Cell Cancer
• Urothelial Cancer of Renal Pelvis

Interventions

Type	Name	Description
RADIATION	Low Dose Rate Brachytherapy (LDR)	LDR on treatment day 1
DRUG	Standard-of-Care Immunotherapy	Standard or care immunotherapy will be administered at the FDA approved dose via IV infusion.

Timeline

• Start date: 2021-05-27
• Primary completion: 2024-03-20
• Completion: 2026-02-01
• First posted: 2020-11-09
• Last updated: 2025-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study