Cancer combo drug trial for rare skin cancer withdrawn before starting
NCT ID NCT05846724
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test a combination of two drugs, pembrolizumab and lenvatinib, in people with a rare skin cancer called classic Kaposi sarcoma that had not responded to prior chemotherapy. The goal was to see if the combination could shrink tumors better than standard chemotherapy. However, the trial was withdrawn before enrolling any participants, so no results are available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Feb 2024
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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