Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma

Sponsor
Yonsei University
Study ID
NCT05679921
Phase
PHASE2
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • pembrolizumab, pazopanib — DRUG
    Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing. Participants who complete study intervention after 2 years of pembrolizumab can be treated with pazopanib monotherapy based on physician's judgement. The duration of optional pembrolizumab crossover treatment will be maximum of 2 years i.e. a total of 35 cycles of pembrolizumab for patients progressing on pazopanib.

Study Details

This is an open-label, randomized, phase II study to evaluate the clinical activity of pembrolizumab in combination with pazopanib compared to pazopanib monotherapy.

Key Dates

First listed
Jan 11, 2023
Start date
Mar 1, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PP1
    pembrolizumab in combination with pazopanib
  • Experimental: PP2
    pembrolizumab for patients progressing on pazopanib.

Primary Outcome Measure

Progression Free Rate (PFR) [ Time Frame: 12 weeks ]

Central Contacts

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