NCT05687721 is a Phase 1, PHASE2 clinical trial of copanlisib in Advanced Urothelial Carcinoma, sponsored by VA Office of Research and Development.

Who is sponsoring NCT05687721?

NCT05687721 is sponsored by VA Office of Research and Development.

What drugs are being tested in NCT05687721?

Interventions in NCT05687721: copanlisib, Avelumab.

What condition does NCT05687721 study?

NCT05687721 studies Advanced Urothelial Carcinoma.

Is NCT05687721 still recruiting?

NCT05687721 is currently withdrawn. Last updated 15 June 2025.

Last reviewed 2025-06-15 · How we verify

NCT05687721

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

Withdrawn Phase 1, PHASE2 Last updated 15 June 2025

What this trial tests

Phase 1, PHASE2 trial testing copanlisib in Advanced Urothelial Carcinoma. Withdrawn.

Timeline

2 June 2025

Primary endpoint
2 June 2025

2 June 2025

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	2 June 2025
Primary completion	2 June 2025
Estimated completion	2 June 2025
Sites	1 location across United States

Drugs / interventions tested

copanlisib (COPANLISIB) — full drug profile →
Avelumab (avelumab) — full drug profile →

Conditions studied

Advanced Urothelial Carcinoma — all drugs for Advanced Urothelial Carcinoma →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Advanced Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Small-molecule agents for cancer immunotherapy.
Wang F, Fu K, Wang Y, Pan C, et al · · 2024 · cited 41× · PMID 38486980 · DOI 10.1016/j.apsb.2023.12.010
A Comprehensive Review of Immunotherapy Clinical Trials for Metastatic Urothelial Carcinoma: Immune Checkpoint Inhibitors Alone or in Combination, Novel Antibodies, Cellular Therapies, and Vaccines.
Patel DM, Mateen R, Qaddour N, Carrillo A, et al · · 2024 · cited 13× · PMID 38254823 · DOI 10.3390/cancers16020335
Urinary comprehensive genomic profiling predicts urothelial carcinoma recurrence and identifies responders to intravesical therapy.
Rac G, Patel HD, James C, Desai S, et al · · 2024 · cited 7× · PMID 37753732 · DOI 10.1002/1878-0261.13530
Landscape of targeted therapies for advanced urothelial carcinoma.
Shang S, Zhang L, Liu K, Lv M, et al · · 2024 · cited 2× · PMID 38966172 · DOI 10.37349/etat.2024.00240
Molecular Basis of Oncogenic PI3K Proteins.
Sheng Z, Beck P, Gabby M, Habte-Mariam S, et al · · 2024 · cited 1× · PMID 39796708 · DOI 10.3390/cancers17010077

Verify or expand the search:

Other recruiting trials for Advanced Urothelial Carcinoma

Currently open trials in the same condition.

NCT07221942 — Pembrolizumab Maintenance After Enfortumab Vedotin (EV)/Pembro Induction in Front-Line Metastatic Urothelial Carcinoma · Phase 2 · recruiting
NCT07241793 — Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metast · Phase 2 · recruiting
NCT07063758 — A Biomarker Study to Predict Treatment Outcomes of Enfortumab Vedotin in Advanced Urothelial Carcinoma · active not recruiting
NCT06904573 — Probiotics in Advanced Urothelial Carcinoma · Phase 2 · recruiting
NCT06639347 — A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma · Phase 1, PHASE2 · recruiting

Other VA Office of Research and Development trials

Trials by the same sponsor.

NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05687721 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 15 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05687721.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing