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NCT06770582 · ClinicalTrials.gov registry record · Phase 2

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial

A Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
160
Enrollment target
20
Study locations

NCT06770582 is a Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 160 participants, below the 197-participant average among 7 other Stage I Bladder Cancer AJCC v8 trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT06770582, a Phase 2 study of Stage I Bladder Cancer AJCC v8 and Non-Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
160 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.

Conditions Studied

Stage I Bladder Cancer AJCC v8 Non-Muscle Invasive Bladder Urothelial Carcinoma Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • DRUG Fluorouracil
  • DRUG Gemcitabine

Study Locations (20)

Illinois

  • Rush MD Anderson Cancer Center - Chicago
  • Carle at The Riverfront - Danville
  • Cancer Care Specialists of Illinois - Decatur - Decatur
  • Decatur Memorial Hospital - Decatur
  • Carle Physician Group-Effingham - Effingham
  • Crossroads Cancer Center - Effingham
  • Carle Physician Group-Mattoon/Charleston - Mattoon

Georgia

  • Grady Health System - Atlanta
  • Emory Proton Therapy Center - Atlanta
  • Emory University Hospital Midtown - Atlanta
  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

California

  • AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles

Delaware

  • Helen F Graham Cancer Center - Newark
  • Medical Oncology Hematology Consultants PA - Newark

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville
  • Mount Sinai Medical Center - Miami Beach

Colorado

  • Shaw Cancer Center - Edwards

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2025-06-03
Est. Completion 2032-02-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06770582

The ClinicalTrials.gov registry entry for NCT06770582 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 7 other Stage I Bladder Cancer AJCC v8 trials with a reported enrollment target (19% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Stage I Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06770582 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Illinois, Georgia, California.

Frequently Asked Questions

What is clinical trial NCT06770582 about?

NCT06770582 is a clinical study titled "Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial". This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may h...

What is the current status of trial NCT06770582?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2025-06-03. Estimated completion is 2032-02-01.

What conditions does trial NCT06770582 study?

This clinical trial studies the following conditions: Stage I Bladder Cancer AJCC v8, Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma.

What interventions are being tested in trial NCT06770582?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Fluorouracil (DRUG), Gemcitabine (DRUG).

Who is sponsoring clinical trial NCT06770582?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06770582 being conducted?

This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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