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

NCT05574504 - Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy | Biotech Hunter | Biotech Hunter