Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Eye Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Uveal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Tislelizumab

Liver Extracts

Antineoplastic Agents, Immunological

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.

Sitravatinib Malate

Josep Maria Piulats, M.D. Ph.D.

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.

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.

ORR is defined as the proportion of patients with at least one visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later according to Response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.

For this protocol, PFS is defined as the time from the first dose of study treatment until objective tumor progression according to RECIST 1.1 criteria or death, whichever occurs first.

Overall Survival is defined as the time from the first dose of study treatment until death from any cause. Those patients that do not present a death event or are lost to follow up will be censored at the date of the last contact.

Percentage of patients who experienced an adverse reaction

Mirati Therapeutics Inc.

BeiGene

Grupo Español Multidisciplinar de Melanoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.	NCT05542342	Uveal Melanoma	Tislelizumab Sitravatinib Ma...	18 Years -	Grupo Español Multidisciplinar de Melanoma
Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.	NCT05542342	Uveal Melanoma	Tislelizumab Sitravatinib Ma...	18 Years -	Grupo Español Multidisciplinar de Melanoma

Spots Global Cancer Trial Database for sitravatinib malate