Copanlisib + Avelumab for Advanced Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byChong-Xian Pan, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Research Team

Chong-Xian Pan, MD PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

Adults over 18 with advanced bladder cancer who've finished first-line platinum-based chemo without disease progression are eligible. They must have a life expectancy of at least 3 months, controlled diabetes (A1c < 8.5%), and be able to perform daily activities with some limitations (ECOG PS ≤2 or Karnofsky ≥60%). Exclusions include recent major surgery, other cancer treatments within the last month, certain prior therapies for bladder cancer, active infections like HIV/HBV/HCV, severe allergies to monoclonal antibodies, and uncontrolled medical conditions.

Inclusion Criteria

Patients must have had X-rays, CT/ MRI scans, PET or physical examinations completed within 28 days prior to initial administration of study medications

Estimated life expectancy of at least 3 months

I finished my first round of platinum-based chemotherapy between 4 and 10 weeks ago.

See 17 more

Exclusion Criteria

I have an autoimmune disease that could worsen with immune-boosting treatments.

I am HIV positive or have AIDS.

You have serious ongoing health problems.

See 22 more

Treatment Details

Interventions

Avelumab (Checkpoint Inhibitor)
Copanlisib (PI3K inhibitor)

Trial OverviewThis trial tests copanlisib in combination with standard immunotherapy drug avelumab as maintenance therapy for patients whose metastatic bladder cancer hasn't progressed after chemotherapy. The goal is to see if this combo can help keep the cancer from advancing further.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Therapeutic armExperimental Treatment2 Interventions

Copanlisib will be administered through intravenous infusion (IV) at 60 mg on Day 1, 8 and 15, and avelumab will be administered 800 mg IV on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles