NCT05574504

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

Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy for Metastatic Urothelial Carcinoma With Stable or Responding Disease Following Platinum-based Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A nonrandomized phase II trial is proposed combining avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin as switch maintenance therapy for mUC following stable or responding disease on 4-6 cycles of first line platinum-based chemotherapy

Detailed description

The purpose of this research is to study benefit of the combination of lurbinectedin chemotherapy with maintenance avelumab immunotherapy in patients with advanced cancer of the urinary tract who have completed platinum-based chemotherapy. Avelumab alone is the usual approach and is already approved by the US FDA for the treatments of patients with this type of cancer. Lurbinectedin is approved for a type of lung cancer, but is not approved for urinary tract cancer.

Conditions

• Metastatic Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-08
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2022-10-10
• Last updated: 2024-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study