Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 8, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2028

Conditions
Metastatic CancerUrothelial Carcinoma
Interventions
DRUG

avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin

"Avelumab 800 mg IV q 2 weeks (days 1,15, and 29 every 6 week cycle ) (premedication includes a H1 blocker, H2 blocker and Tylenol) Lurbinectedin 3.2 mg/m2 administered as a 1-h intravenous infusion once every 3 weeks (day 1 and 22 every 6 week cycle )~1 cycle= 6 weeks~Premedication for lurbinectedin:~* Corticosteroids (dexamethasone 8 mg intravenously or equivalent)~* Serotonin antagonists (ondansetron 8 mg intravenously or equivalent) Granulocyte-colony stimulating factor (G-CSF) or equivalent per ASCO guidelines per investigator discretion"

Trial Locations (1)

32804

AdventHealth Cancer Institute, Orlando

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

AdventHealth

OTHER