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.
Male or female patients are eligible
Histologically or cytologically confirmed advanced or recurrent urothelial carcinoma, OR
Documented Stage IV disease (T4b, Any N, M0; any T, Any N, M1a-b), Stage IIIB (T1-T4a, N2-N3, M0), or a subset of Stage IIIA (T1-T4a, N1, M0)
Genomic testing, including assessment for PIK3CA, AKT1, or PTEN alterations, must have been performed
Patients who have undergone major surgery within 4 weeks, or major radiation therapy within 2 weeks, prior to starting treatment. Prior palliative radiotherapy is permitted if completed at least 48 hours before study entry
Receipt of another investigational agent within the past 4 weeks. Participation in observational studies is allowed
Persistent toxicities (CTCAE Grade ≥2) from previous anticancer therapy, except for alopecia. Patients with irreversible toxicity not reasonably expected to be exacerbated by study intervention (as deemed by the investigator, such as hearing loss) may be included.
Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow capivasertib, or prior significant bowel resection that may impair adequate absorption, distribution, metabolism, or excretion of capivasertib.
Single group
capivasertib
DrugPatients will continue their immune checkpoint inhibitor (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.
Objective response rate (ORR)
ORR is defined as the percentage of patients who have a partial or complete response at any time during the treatment of this trial.
Progression-free survival (PFS)
PFS is defined as the time between initiation of the ICI/capivasertib combination treatment and tumor progression or death from any cause, with censoring of patients who are lost to follow-up
Overall survival (OS)
OS is defined as the length of time from the start of this trial treatment to the time of death from any cause, with censoring of patients who are lost to follow-up.
Disease control rate (DCR)
DCR is the percentage of patients who have a partial or complete response or stable disease at any time during this treatment of this trial.
Safety
Safety will be determined by percentage of patients who develop adverse events (AEs) during the study. AEs will be graded on a 1-5 scale based on the Common Terminology Criteria for Adverse Events (CTCAE).
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This trial is not recruiting at the moment. You can still explore other options:
