Kaposi SarcomaPhase 2PULSARNCT05846724
Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma
A Phase 2 study testing Pembrolizumab + Lenvatinib in people with Kaposi Sarcoma and Classic Kaposi Sarcoma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
Phase II study of Pembrolizumab plus Lenvatinib in relapsed/refractory Classic Kaposi Sarcoma (CKS). After a screening phase of up to 28 days, each participant will receive study intervention of pembrolizumab plus lenvatinib until reaching a discontinuation criterion: disease progression; unacceptable adverse event(s)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma, Classic Kaposi Sarcoma, Refractory Kaposi Sarcoma
- What is being tested?
- Pembrolizumab + Lenvatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Feb 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a histologically confirmed diagnosis of classic (or endemic) KS
- Progression or inadequate response to at least one prior systemic chemotherapy
- Presence of measurable disease by PET-CT scan and/or dermatological examination
- KS with at least 10 cutaneous and/or mucosal lesions, or involving more than one limb segment or with involvement >3% body surface
- KS with at least 4 lesions ≥ 5mm
- KS with at least 1 superficial lesion willing to provide tissue from cutaneous and/or mucosal biopsy at baseline
Show all 10Show fewer
- At least 4 weeks washout for all KS specific therapies including chemotherapy (both systemic and intralesional) and radiotherapy
- 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
- 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.
Who cannot join
- Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies detected at screening).
- 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.
- 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.
- 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).
- 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.
About this study
Official title: A Phase II Single-arm Study of Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma (CKS)
Phase II study of Pembrolizumab plus Lenvatinib in relapsed/refractory Classic Kaposi Sarcoma (CKS). After a screening phase of up to 28 days, each participant will receive study intervention of pembrolizumab plus lenvatinib until reaching a discontinuation criterion: disease progression; unacceptable adverse event(s) (AEs); intercurrent illness that prevents further administration of treatment; participant withdraws consent; pregnancy of participant; non-compliance with study intervention or procedure requirements; or administrative reasons requiring cessation of treatment.
After the end of treatment, each participant will be followed for the occurrence of AEs and spontaneously reported pregnancy.
Read more
Participants who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD is documented clinically by a team of committed dermatologists, and/or radiographically per RECIST 1.1, a non-study anticancer treatment is initiated, consent is withdrawn, or the participant becomes lost to follow-up.
All participants will be followed for overall survival (OS) until death, withdrawal of consent,lost to follow-up, or the end of the study. The end of the study will be when the last participant completes the last study-related telephone call or visit,withdraws from the study, or is lost to follow-up.
- Being tested
- Pembrolizumab + Lenvatinib
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab + LenvatinibDrug
single-arm study of pembrolizumab plus lenvatinib
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Drug: Pembrolizumab + Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) of pembrolizumab with lenvatinib in pre-treated recurrent CKS
the combination of pembrolizumab and lenvatinib has superior ORR, as compared to cytotoxic chemotherapy by literature data. ORR defined as a confirmed complete response (CR) or partial response (PR).
Measured: 6 months
Secondary outcomes (5)
Duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib
The combination of pembrolizumab and lenvatinib provides superior DOR, as compared to cytotoxic chemotherapy by literature data.
Measured: 6 months
Progression Free Survival (PFS) of patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib.
The combination of pembrolizumab and lenvatinib has superior PFS, as compared to cytotoxic chemotherapy by literature data.
Measured: 6 months
Overall Survival in patients receiving pembrolizumab and lenvatinib
The combination of pembrolizumab and lenvatinib has superior OS, as compared to cytotoxic chemotherapy by literature data.
Measured: 6 months
The mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib
Score for the following patient-reported outcomes (PROs) scales/items: global health status/QoL (EORTC QLQ-C30items 29 and 30), and physical functioning (EORTC QLQ-C30 items 1-5).
Measured: 6 months
Safety and tolerability for the combination of pembrolizumab and lenvatinib.
Adverse Events (AEs) incidence and study intervention discontinuation due to AEs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Why it stopped: The lack of adequate funding has made it impossible to continue with the clinical study As this study was not initiated, no subject was included and no data was collected,thus no result can be obtained SPONSOR\_DECISION End of trial date:15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846724
- Sponsor's protocol ID
- MK-3475-B60
- Acronym
- PULSAR
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-arm Study of Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma (CKS)
- ClinicalTrials.gov ID
- NCT05846724
- Acronym / sponsor ID
- PULSAR / MK-3475-B60
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The lack of adequate funding has made it impossible to continue with the clinical study As this study was not initiated, no subject was included and no data was collected,thus no result can be obtained SPONSOR\_DECISION End of trial date:15 Oct 2025
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II study of Pembrolizumab plus Lenvatinib in relapsed/refractory Classic Kaposi Sarcoma (CKS). After a screening phase of up to 28 days, each participant will receive study intervention of pembrolizumab plus lenvatinib until reaching a discontinuation criterion: disease progression; unacceptable adverse event(s) (AEs); intercurrent illness that prevents further administration of treatment; participant withdraws consent; pregnancy of participant; non-compliance with study intervention or procedure requirements; or administrative reasons requiring cessation of treatment.
After the end of treatment, each participant will be followed for the occurrence of AEs and spontaneously reported pregnancy.
Participants who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD is documented clinically by a team of committed dermatologists, and/or radiographically per RECIST 1.1, a non-study anticancer treatment is initiated, consent is withdrawn, or the participant becomes lost to follow-up.
All participants will be followed for overall survival (OS) until death, withdrawal of consent,lost to follow-up, or the end of the study. The end of the study will be when the last participant completes the last study-related telephone call or visit,withdraws from the study, or is lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Pembrolizumab + Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a histologically confirmed diagnosis of classic (or endemic) KS
- Progression or inadequate response to at least one prior systemic chemotherapy
- Presence of measurable disease by PET-CT scan and/or dermatological examination
- KS with at least 10 cutaneous and/or mucosal lesions, or involving more than one limb segment or with involvement >3% body surface
- KS with at least 4 lesions ≥ 5mm
Key exclusion criteria (5 listed)
- Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies detected at screening).
- 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.
- 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.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab + Lenvatinibsingle-arm study of pembrolizumab plus lenvatinib | Drug | Single Arm |
Primary outcome
Overall Response Rate (ORR) of pembrolizumab with lenvatinib in pre-treated recurrent CKS
Time frame: 6 months
the combination of pembrolizumab and lenvatinib has superior ORR, as compared to cytotoxic chemotherapy by literature data. ORR defined as a confirmed complete response (CR) or partial response (PR).
5 secondary outcomes
Duration of response (DOR) in patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib
Time frame: 6 months
Progression Free Survival (PFS) of patients with pre-treated recurrent CKS receiving pembrolizumab with lenvatinib.
Time frame: 6 months
Overall Survival in patients receiving pembrolizumab and lenvatinib
Time frame: 6 months
The mean change from baseline in the global health status/quality of life (QoL), and physical functioning for the combinations of pembrolizumab and lenvatinib
Time frame: 6 months
Safety and tolerability for the combination of pembrolizumab and lenvatinib.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab + Lenvatinib in people with Kaposi Sarcoma and Classic Kaposi Sarcoma, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) of pembrolizumab with lenvatinib in pre-treated recurrent CKS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.