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Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer

NCT03150836 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-10-19

No results posted yet for this study

Summary

This is a multi-site, randomized, prospective, open-label phase II study. Patients in this study will have localized (cT3-cT4), or metastatic bladder cancer with a symptomatic, intact primary bladder tumor. In this study, patients will undergo stereotactic body radiation therapy (SBRT) to the bladder tumor and will receive durvalumab with or without tremelimumab.

Conditions

Interventions

DRUG

Durvalumab

All participants will receive durvalumab 1500 mg via IV infusion every 4 weeks for up to 13 doses.

DRUG

Tremelimumab

Participants receiving Regimen B (safety lead-in or expansion cohort) will be administered tremelimumab 75 mg via IV infusion every 4 weeks for 1 cycle or 2 cycles.

RADIATION

Radiation Therapy

In all arms of the study, participants will receive 5 fractions of radiation. The radiation dose will either be 6.6 Gy for a total dose of 33 Gy, or 6.0 Gy for a total dose of 30 Gy.

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • Terence Friedlander, MD

    lead OTHER

Principal Investigators

  • Terence Friedlander, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2021-09-01
Completion
2024-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150836 on ClinicalTrials.gov