Clinical Trials Directory

Trials / Completed

CompletedNCT03798106

A Study of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma

A Phase II Trial of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Detailed description

Pazopanib is an angiogenesis inhibitor targeting VEGFR-1, -2, and -3; PDGFR-α and -β; and the receptor c-Kit, and is indicated for the treatment of subjects with advanced renal cell carcinoma (RCC) and advanced STS. Pro-angiogenic factors suppress various immune functions whereas antiangiogenic agents have potential to modulate the tumor microenvironment and improve immunotherapy. An analysis of patients with RCC treated with pazopanib demonstrated that elevated expression of PD-L1 correlates with shorter PFS. Investigator also identified 43% of PD-L1 expression in STS and PD-L1 expression had worse overall survival (5-year survival rate: 48% in PD-L1 positive vs. 68% in PD-L1 negative, p=0.015). In detail, PD-L1 expression was reported 52.6% in synovial sarcoma, 37.6% in rhabdomyosarcoma, and 100% in epithelioid sarcoma. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination.

Conditions

Interventions

TypeNameDescription
DRUGDurvalumab, pazopanibDurvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks

Timeline

Start date
2019-04-10
Primary completion
2022-08-10
Completion
2022-08-10
First posted
2019-01-09
Last updated
2023-06-12

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03798106. Inclusion in this directory is not an endorsement.