NCT05542342

Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.

Phase II, Open-Label Study of Preliminary Efficacy of Sitravatinib in Combination With Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Grupo Español Multidisciplinar de Melanoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SITISVEAL stablish the hypothesis that treatment with Tislelizumab + Sitravatinib will increase the Objective Response Rate in patients with Metastatic Uveal Melanoma (mUM) with liver metastases, compared with the current standard of care. This is a non-randomized, single arm, multicenter, phase II study of Sitravatinib in combination with Tislelizumab in subjects with metastatic uveal melanoma and liver metastases. After informed consent is obtained, subjects will enter in the Screening phase to assess eligibility criteria and perform a mandatory tumor biopsy. Upon meeting criteria, eligible subjects will be entered into the Treatment phase. Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Tislelizumab	200 mg IV once every 3 weeks
DRUG	Sitravatinib Malate	100 mg orally once daily

Timeline

• Start date: 2022-09-23
• Primary completion: 2023-12-31
• Completion: 2025-05-06
• First posted: 2022-09-15
• Last updated: 2025-05-14

Locations

4 sites across 1 country: Spain