Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT07793578
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • capivasertib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment
    Patients will continue ICI treatment and capivasertib will be added

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Yu Zhang, MD
[email protected]
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Colleen Hynes, BS
[email protected]
(857) 720-5501
Chong-Xian Pan, MD PhD (PRINCIPAL_INVESTIGATOR)
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
Yu-Ning Wang, MD
[email protected]
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Robert B Montgomery, MD
[email protected]

Find similar trials in West Haven, CT

By research site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT· West Haven, CTVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MACorporal Michael J. Crescenz VA Medical Center, Philadelphia, PA· Philadelphia, PAVA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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