NCT05679921

Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma

Pazopanib With or Without Pembrolizumab for Metastatic Soft Tissue Sarcoma: Open-label, Multicenter, Randomized, Phase 2 Trials

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	pembrolizumab, pazopanib	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-01-11
• Last updated: 2025-07-16

Locations

1 site across 1 country: South Korea