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Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer

NCT07793578 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-28

No results posted yet for this study

Summary

This study aims to determine whether adding an oral medication called Capivasertib to ongoing immunotherapy can enhance treatment responses in patients with advanced bladder cancer (aBC), as well as to evaluate the safety of this combination. Capivasertib is an anti-cancer drug approved by the U.S. Food and Drug Administration (FDA) for breast cancer, but it is not approved for aBC and, in this study, will be used as an investigational agent. Immunotherapy is FDA-approved for aBC, yet while some patients respond, others either do not benefit or develop resistance after an initial response. Previous research indicates that drugs similar to Capivasertib may increase the effectiveness of immunotherapy. Therefore, this study will enroll patients whose aBC no longer responds to immunotherapy, add Capivasertib to their treatment regimen, and monitor for improvements in immune response against aBC and any potential side effects associated with the combination therapy.

Conditions

  • Advanced Urothelial Carcinoma

Interventions

DRUG

capivasertib

Patients will continue their ICI treatment, with capivasertib added at a dose of 400 mg orally twice daily, administered on a schedule of 4 days on followed by 3 days off, continuously throughout the study period.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Chong-Xian Pan, MD PhD · VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-09-30
Completion
2030-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07793578 on ClinicalTrials.gov