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

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth
Study ID
NCT05574504
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin — DRUG
    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

Study Details

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

Key Dates

Start date
May 8, 2023
Status verified
Jul 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin
    Phase II trial is designed to evaluate the combination of avelumab (800 mg IV every 2 weeks-(days 1,15, and 29 every 6 week cycle ) and lurbinectedin (3·2 mg/m2 lurbinectedin administered as a 1-h intravenous infusion once every 3 weeks-day 1 and 22 every 6 week cycle ) for those with stable or responding disease following 4-6 cycles of platinum-based firstline chemotherapy for mUC with stable or responding disease following 4-6 cycles of platinum-based firstline chemotherapy for mUC.

Primary Outcome Measure

The combination of lurbinectedin chemotherapy with maintenance avelumab immunotherapy in patients with advanced cancer of the urinary tract [ Time Frame: 32 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth Cancer InstituteOrlandoFlorida32804-

Find similar trials in Orlando, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
AdventHealth Cancer Institute· Orlando, FL

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