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Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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.

NCT05542342•Grupo Español Multidisciplinar de Melanoma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Coordinating Investigator.
•2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with Tislelizumab may be included only after consultation with the Coordinating Investigator.
•3. Known toxicity on prior checkpoint inhibitor treatment:
•I) Grade ≥ 3 immune-related adverse event (AE) related to checkpoint inhibitors.
•II) Grade 2 immune-related AE associated with checkpoint inhibitor unless the AE resolved or was well III) controlled by withholding the checkpoint inhibitor and/or treatment with steroids, with the exception of prior colitis, myocarditis, and pneumonitis, which are exclusionary.
•CNS or ocular AE of any grade related to checkpoint inhibitors. Note: Patients with a prior endocrine AE are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.
•10. Any concurrent chemotherapy, investigational medicinal product (IMP), biologic, or hormonal therapy for cancer treatment different to Sitravatinib and/or Tislelizumab. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
•11. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
•12. Major surgery within a minimum of 4 weeks prior to inclusion; patients must have recovered from any effects of any major surgery prior to inclusion. Note: Local surgery of isolated lesions for palliative intent and minor surgeries performed to obtain biological material for the study (i.e. liver biopsy) are acceptable.
•13. History of allogeneic organ transplantation.
+37 more criteria

Exclusion Criteria

•2. Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. Patients must have at least 1 biopsiable liver metastasis.
•3. Patients who are human leucocites antigen (HLA)-A02:01 positive can have received one prior therapy with Tebentafusp for metastatic disease.
•4. Patients must be 18 years of age or older at time of study entry.
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
•6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations not performed according to normal practice. Patients must consent for liver metastasis biopsies donation at day 0 and day +42 since treatment initiation.
•7. Adequate normal organ and marrow function as defined below:
•a) Haemoglobin ≥9.0 g/dL b) Absolute neutrophil count (ANC) \>1.5 x 109/L (\> 1500 per mm3) c) Platelet count ≥ 100 x 109/L (\>75,000 per mm3) d) Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with Coordinating Investigator e) Both aspartate aminotrnsferase (AST) and alanine aminotransferase (ALT) must be \< 5 x ULN.
•f) Creatinine clearance ⩾40 ml/min calculated by Cockcroft-Gault or another validated method g) Urine protein:creatinine ratio (UPC) ≤1 or ≤2+ proteinuria on 2 consecutive dipsticks taken no less than 1 week apart h) Subjects with 2+ proteinuria on dipstick must also have UPC \< 0.5 on 2 consecutive samples.
•8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for 6 months after the last dose of Tislelizumab and/or Sitravatinib, and have a negative urine or serum pregnancy test ≤ 7 days before first administration of Tislelizumab and Sitravatinib. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
•a) Amenorrheic for ≥1 year in the absence of chemotherapy and/or hormonal treatments b) Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range c) Radiation induced oophorectomy with last menses \>1 year ago d) Chemotherapy induced menopause with \>1 year interval since last menses e) Surgical sterilization (bilateral oophorectomy or hysterectomy) f) Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) g) Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
+16 more criteria

Locations (4)

Hospital Universitario Virgen de la Macarena

Seville, Andalusia, Spain

Institut Catala Oncologia (ICO) L´Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario la Paz

Madrid, Madrid, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Key Dates

Start Date

September 23, 2022

Primary Completion Date

December 31, 2023

Completion Date

May 6, 2025

Last Updated

May 14, 2025

Enrollment

ACTUAL participants

Conditions

Uveal Melanoma

Interventions

Tislelizumab

DRUG

Sitravatinib Malate

DRUG

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Choroidal MelanomaIndeterminate Lesions+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma

A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adding IL-2 to Tebentafusp to Eradicate Cancer Progression

Adjuvant Melatonin for Uveal Melanoma