Cutaneous SarcomaPhase 2NCT07007273
Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma
A Phase 2 study testing Pembrolizumab in people with Cutaneous Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and/or gender. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Sarcoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jun 2025to Jul 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of soft tissue sarcoma, not including angiosarcoma, will be enrolled on study. The primary tumor site must be deemed to be cutaneous or dermal in the opinion of the treating investigator (note the primary tumor site does NOT need to be present at the time of screening, i.e., may have been previously resected but recurred and/or metastasized).
- Participants must have metastatic or advanced disease which could include recurrent, unresectable or multifocal lesions or in which resection would result in unacceptable morbidity per the treating investigator.
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Archival tumor tissue sample or newly obtained [core, punch, incisional, or excisional] biopsy of a tumor lesion not previously irradiated is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Prior oncologic therapy is allowable but not required. Must be at least 4 weeks since prior systemic anti-cancer therapy including investigational agents prior to start of study treatment. For prior tyrosine kinase inhibitor therapy, 3 drug half-lives may instead be used for this criterion (if shorter). Must be at least 2 weeks since prior radiotherapy prior to start of study treatment.
- Have an ECOG performance status ≤ 1.
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- Participants must have adequate organ and marrow function as defined in the protocol.
- HIV-infected participants must have well-controlled HIV on ART.
- Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system- (CNS-) directed therapy shows no evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy.
- Participants with a prior or concurrent malignancy are eligible for this trial if the malignancy is not progressing and has not required therapy in the past 3 years.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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).
- Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia or participants who have ≤Grade 2 neuropathy.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of other vaccine types is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)
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- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Andrew Brohl, MD
Mihaela Druta, MD
About this study
This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and/or gender. Approximately N=17 patients are planned to be enrolled. Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).
- Conditions
- Cutaneous Sarcoma
- Being tested
- Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Outpatient infusion
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab Treatment | Experimental | Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks). Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate will be determined by RECIST 1.1.
Measured: Up to 3 years
Secondary outcomes (2)
Overall Survival (OS)
Overall survival (OS) will be assessed by Kaplan-Meier method.
Measured: Up to 3 years
Progression Free Survival (PFS)
Progression free survival (PFS) will be assessed by Kaplan-Meier method.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start20 Jun 2025
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous SarcomaStudies of the same condition, open and under way.
- 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
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Andrew Brohl, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007273
- Sponsor's protocol ID
- MCC-23318
- Status last verified
- Mar 2026
- First submitted
- 28 May 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma
- ClinicalTrials.gov ID
- NCT07007273
- Acronym / sponsor ID
- MCC-23318
- Conditions
- Cutaneous Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 5 Jun 2025 (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.
This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and/or gender. Approximately N=17 patients are planned to be enrolled. Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab Treatment | Experimental | Drug: PembrolizumabPembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of soft tissue sarcoma, not including angiosarcoma, will be enrolled on study. The primary tumor site must be deemed to be cutaneous or dermal in the opinion of the treating investigator (note the primary tumor site does NOT need to be present at the time of screening, i.e., may have been previously resected but recurred and/or metastasized).
- Participants must have metastatic or advanced disease which could include recurrent, unresectable or multifocal lesions or in which resection would result in unacceptable morbidity per the treating investigator.
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Archival tumor tissue sample or newly obtained [core, punch, incisional, or excisional] biopsy of a tumor lesion not previously irradiated is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Prior oncologic therapy is allowable but not required. Must be at least 4 weeks since prior systemic anti-cancer therapy including investigational agents prior to start of study treatment. For prior tyrosine kinase inhibitor therapy, 3 drug half-lives may instead be used for this criterion (if shorter). Must be at least 2 weeks since prior radiotherapy prior to start of study treatment.
Key exclusion criteria (13 listed)
- 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).
- Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia or participants who have ≤Grade 2 neuropathy.
- Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of other vaccine types is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaOutpatient infusion | Drug | Pembrolizumab Treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 3 years
Objective response rate will be determined by RECIST 1.1.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years
Progression Free Survival (PFS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Brohl, MD principal investigator
Moffitt Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Cutaneous Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristie Newsome (813-745-5978, Kristie.Newsome@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 3 years). 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 1 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.