Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer (NCT05687721) | Clinical Trial Compass
WithdrawnPhase 1/2
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
Stopped: The study drug is not available.
United States0Started 2025-06-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female
✓. Age \> 18 years
✓. Diagnosis:
✓. Histologically or cytologically confirmed metastatic or recurrent urothelial carcinoma. OR
✓. Documented stage IV disease (T4b, Any N, M0; any T, Any N, M1a-b), or Stage IIIB (T1-T4a, N2-N3, M0), or subset of stage IIIA (T1-T4a, N1, M0)
✓. Completed prior first-line platinum-based chemotherapy at least 4 weeks and not more than 10 weeks after the last dose of first line chemotherapy.
✓. Patients without progressive disease as per RECIST v1.1 guideline (i.e., with an ongoing CR, PR, or SD) following completion of the first-line chemotherapy.
✓. Patient must be appropriate to receive Avelumab maintenance therapy
Exclusion criteria
✕. Estimated life expectancy of at least 3 months.
✕0. Eastern Cooperative Oncology Group (ECOG) performance status (PS) status 2 OR Karnofsky Performance Status scale 60%. For the safety lead-in phase, only patients with PS 0-1 will be included.
✕. Hemoglobin \> 9 g/dL (may have been transfused).
✕2. Adequate renal function, defined as estimated creatinine clearance 20 mL/minute as calculated using the Cockcroft-Gault equation. It has been shown that creatinine clearance 15 ml/minute did not significantly affect the pharmacokinetics of copanlisib.