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Clinical trial of combined therapy with pembrolizumab and lenvatinib for patients with classic Kaposi sarcoma treated with at least one previous line of chemioterapy.
EU CTIS ID: 2024-512834-14-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility criteria
- 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.