Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment of pembrolizumab and lenvatinib for patients with classic Kaposi Sarcoma (CKS) who have already tried other treatments without success. Kaposi Sarcoma is a type of cancer that causes lesions on the skin and can also affect other parts of the body. To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of classic Kaposi Sarcoma that has worsened or not responded to at least one previous treatment. They should have measurable disease with a specific number of lesions and must not have certain health conditions, like HIV or active autoimmune diseases.

Participants in the trial will receive the study treatment until their disease progresses, they experience unacceptable side effects, or they choose to stop participating. After treatment ends, they will continue to be monitored for any side effects and disease status. The trial aims to understand how well this combination treatment works and how it affects overall survival. It’s important to note that this trial is not yet recruiting participants, so those interested should keep an eye out for updates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have a histologically confirmed diagnosis of classic (or endemic) KS
• • 2. Progression or inadequate response to at least one prior systemic chemotherapy
• • 3. Presence of measurable disease by PET-CT scan and/or dermatological examination
• • 4. KS with at least 10 cutaneous and/or mucosal lesions, or involving more than one limb segment or with involvement \>3% body surface
• • 5. KS with at least 4 lesions ≥ 5mm
• • 6. KS with at least 1 superficial lesion willing to provide tissue from cutaneous and/or mucosal biopsy at baseline
• • 7. At least 4 weeks washout for all KS specific therapies including chemotherapy (both systemic and intralesional) and radiotherapy
• • 8. Be ≥ 18 years of age at the time of signing informed consent
• • 9. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• • 10. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week prior to randomization.
• Exclusion Criteria:
• • 1. Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies detected at screening).
• • 2. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
• • 3. 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). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, type I diabetes mellitus, hypothyroidism, psoriasis not requiring systemic treatment are permitted to enroll.
• • 4. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• • 5. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.