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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519451-29-00

Acronym

GEM-2101

Enrollment

Registered

2024-12-10

Start date

2022-09-23

Completion date

2025-05-06

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal melanoma

Brief summary

Objective Response rate (ORR) according to RECIST 1.1 criteria

Detailed description

Secondary efficacy endpoints: 1. Progression Free Survival (PFS) according to RECIST 1.1 criteria. For this protocol, PFS is defined as the time from the first dose of study treatment until objective tumor progression or death according to section 12.1.2., Overall Survival (OS). Overall Survival is defined as the time from the first dose of study treatment until death from any cause.

Interventions

DRUGSitravatinib

DRUGTislelizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response rate (ORR) according to RECIST 1.1 criteria	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: 1. Progression Free Survival (PFS) according to RECIST 1.1 criteria. For this protocol, PFS is defined as the time from the first dose of study treatment until objective tumor progression or death according to section 12.1.2., Overall Survival (OS). Overall Survival is defined as the time from the first dose of study treatment until death from any cause.	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026