2024-519451-29-00
Completed
Phase 2
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.
Grupo Espanol Multidisciplinar De Melanoma2 sites in 1 country16 target enrollmentStarted: December 10, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Grupo Espanol Multidisciplinar De Melanoma
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Objective Response rate (ORR) according to RECIST 1.1 criteria
Overview
Brief Summary
The primary objective is to evaluate the efficacy of the combination of Sitravatinib and Tislelizumab in patients with mUM with liver metastases and biopsiable disease at first line or after failure to first line systemic therapy with Tebentafusp (only HLA-A02:01 positive patients) or liver directed therapy in terms of objective response rate according to RECIST 1.1 criteria.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have histologically confirmed metastatic uveal melanoma with measurable disease not eligible for curative therapy.
- •Patient is willing and able to comply with the protocol procedures for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •Must have a life expectancy minimum of 4 months
- •Subjects must be able to swallow and retain oral medications and be without clinically significant gastrointestinal illnesses that would preclude absorption of Sitravatinib.
- •Adequately controlled blood pressure (BP): ● Systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg in the presence or absence of a stable regimen of antihypertensive therapy.
- •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
- •Patients who are HLA-A02:01 positive can have received one prior therapy with Tebentafusp for metastatic disease
- •Patients must be 18 years of age or older at time of study entry.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •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
Exclusion Criteria
- •Patients with concomitant malignancy other than non-melanoma skin cancer, or superficial bladder cancer controlled with local treatment.
- •Any concurrent chemotherapy, 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.
- •Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation prior to 4 weeks of the first dose of study drug.
- •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.
- •History of allogeneic organ transplantation.
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: a. Patients with vitiligo or alopecia b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement c. Any chronic skin condition that does not require systemic therapy d. Patients without active disease in the last 5 years may be included but only after consultation with the Coordinating Investigator e. Patients with celiac disease controlled by diet alone
- •Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled/malignant hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, compromise Sitravatinib absorption, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- •History of another primary malignancy except for: a. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IMP and of low potential risk for recurrence b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease c. Adequately treated carcinoma in situ without evidence of disease
- •History of active primary immunodeficiency.
- •Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibodies are eligible only if polymerase chain reaction is negative for HCV RNA. Patients with HIV infection but with controlled and treated disease and undetectable viral load, would be eligible.
Outcomes
Primary Outcomes
Objective Response rate (ORR) according to RECIST 1.1 criteria
Objective Response rate (ORR) according to RECIST 1.1 criteria
Secondary Outcomes
- 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.
Investigators
A person designated by the Sponsor
Scientific
Grupo Espanol Multidisciplinar De Melanoma
Study Sites (2)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell LymphomaNCT07261163Institute of Hematology & Blood Diseases Hospital, China37
Not yet recruiting
Not Applicable
A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström MacroglobulinemiaNCT07259122Institute of Hematology & Blood Diseases Hospital, China43
Completed
Phase 2
Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases.Uveal MelanomaNCT05542342Grupo Español Multidisciplinar de Melanoma16
Not yet recruiting
Not Applicable
Lucentis Plus Tagolimumab in PD-L1+, HR+/HER2- Advanced Breast Cancer After CDK4/6 InhibitorsNCT07258108Sun Yat-sen University35
Not yet recruiting
Phase 2
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.2024-516005-23-00Centre Hospitalier Regional Universitaire34