Clinical trial of combined therapy with pembrolizumab and lenvatinib for patients with classic Kaposi sarcoma treated with at least one previous line of chemioterapy.
- Conditions
- Advanced unresectable classic Kaposi sarcoma relapsed and/or refractory to previous standard treatments.MedDRA version: 20.0Level: PTClassification code 10023284Term: Kaposi's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2020-004426-36-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 25
Histologic diagnosis of classic Kaposi sarcoma; progression, relapse or inadequate response to at least one prior systemic chemotherapy; presence of measurable disease by Positron Emission Tomography-Computed Tomography (PET-CT) scan and/or dermatological examination; at least 1 superficial lesion willing to provide tissue from cutaneous and/or mucosal biopsy at baseline; be = 18 years of age at the time of signing informed consent; have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days before the first dose of study intervention; have adequate bone marrow, liver and renal function; have adequately controlled blood pressure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Has a known history of human immunodeficiency virus (HIV) infection, of active infectious hepatitis type B (hepatitis B surface antigen [HBsAg] detected) or C (hepatitis C virus [HCV] ribonucleic acid [RNA] detected) or active Tuberculosis Bacillus (TB); presence of known additional malignancy that is progressing or requires active treatment; has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); has had an allogeneic tissue/solid organ transplant; significant cardiovascular impairment within 12 months of the first dose of study intervention; history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption; previous immunotherapy with ICI(s).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the study is to evaluate the response rate to the treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory Kaposi sarcoma.;Secondary Objective: The secondary objective of the study include the evaluation of the duration of response; evaluation of the impact of combination therapy on survival; treatment tolerability in this patients’ subgroup (including evaluation of the incidence of treatment related adverse events, and the impact of treatment on the patients’ quality of life).;Primary end point(s): The primary endpoint of the study is to estimate the overall response rate (ORR) during treatment with pembrolizumab and lenvatinib in patients with previously treated relapsed/refractory classic Kaposi sarcoma.;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method