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Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

NCT02812420 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-05

No results posted yet for this study

Summary

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Conditions

  • Hydronephrosis
  • Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
  • Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant
  • Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant
  • Infiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid Variant
  • Renal Pelvis Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
  • Stage II Renal Pelvis Cancer AJCC v7
  • Stage II Ureter Cancer AJCC v7
  • Stage II Urethral Cancer AJCC v7
  • Stage III Bladder Urothelial Carcinoma AJCC v6 and v7
  • Stage III Renal Pelvis Cancer AJCC v7
  • Stage III Ureter Cancer AJCC v7
  • Stage III Urethral Cancer AJCC v7
  • Stage IV Renal Pelvis Cancer AJCC v7
  • Stage IV Ureter Cancer AJCC v7
  • Stage IV Urethral Cancer AJCC v7
  • Ureter Urothelial Carcinoma
  • Urethral Urothelial Carcinoma

Interventions

BIOLOGICAL

Durvalumab

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo cystectomy with pelvic lymph node dissection

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jianjun Gao · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02812420 on ClinicalTrials.gov