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Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

NCT05687721 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-06-15

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Urothelial Carcinoma

Interventions

DRUG

copanlisib

intravenous infusion (IV) at 60 mg on Day 1, 8 and 15 of each 4-week treatment cycle for up to 26 cycles

DRUG

Avelumab

800 mg intravenous infusion on Day 1 and 15 of each 4-week treatment cycle for up to 26 cycles

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • 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
2025-06-02
Primary Completion
2025-06-02
Completion
2025-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT05687721 on ClinicalTrials.gov