Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT06385548
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Lurbinectedin — DRUG
    participants will receive intravenous infusions of lurbinectedin at a dose of 2.6 mg/m², diluted in a minimum of 100 mL of either 5% glucose solution or 0.9% sodium chloride solution. The infusion will last for one hour and will be administered every three weeks.
  • Dostarlimab — DRUG
    participants will receive intravenous infusions of dostarlimab at a fixed dose of 500 mg, administered over 30 minutes on Day 1 of each three-week cycle.

Study Details

Background: Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy. Primary Objectives: To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer. To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer. Secondary Objectives: To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy. To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer. To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer. To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer.

Key Dates

Start date
May 31, 2024
Status verified
Apr 2024
Primary completion
May 1, 2024
Completion
Apr 30, 2026

Study Design

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

Arms

  • Experimental: Lurbinectedin and Dostarlimab Combination Therapy

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination [ Time Frame: MTD and RD will be assessed during the Phase I portion of the study, the time frame will be arround 6 months. ]

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