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

NCT05542342 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-14

No results posted yet for this study

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

Interventions

DRUG

Tislelizumab

200 mg IV once every 3 weeks

DRUG

Sitravatinib Malate

100 mg orally once daily

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    collaborator INDUSTRY

  • BeiGene

    collaborator INDUSTRY

  • Grupo Español Multidisciplinar de Melanoma

    lead OTHER

Principal Investigators

  • Josep Maria Piulats, M.D. Ph.D. · ICO L´Hospitalet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2023-12-31
Completion
2025-05-06

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542342 on ClinicalTrials.gov