Actively Recruiting
Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
17
Participants Needed
3
Research Sites
262 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older with histologically confirmed soft tissue sarcoma, excluding angiosarcoma, with the primary tumor site considered cutaneous or dermal
- Metastatic or advanced disease, including recurrent, unresectable, or multifocal lesions, or where surgery would cause unacceptable harm
- Measurable disease based on RECIST 1.1 criteria, including lesions in previously irradiated areas if progression is shown
- Availability of archival tumor tissue or a newly obtained biopsy of a tumor lesion not previously irradiated; formalin-fixed, paraffin-embedded tissue blocks preferred
- At least 4 weeks since prior systemic anti-cancer therapy or 3 drug half-lives for prior tyrosine kinase inhibitor therapy; at least 2 weeks since prior radiotherapy before study treatment
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as defined by the study protocol
- Well-controlled HIV infection on antiretroviral therapy
- For HBsAg positive participants, at least 4 weeks of HBV antiviral therapy and undetectable HBV viral load prior to randomization
- History of HCV infection allowed if viral load is undetectable at screening
- Treated brain metastases allowed if stable without steroids and no progression for at least 4 weeks
- Prior or concurrent malignancy allowed if not progressing and no therapy required in past 3 years
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeting agents (e.g., CTLA-4, OX-40, CD137)
- Unresolved toxicities from prior anti-cancer therapy greater than Grade 1, except alopecia or neuropathy Grade 2 or less
- Receipt of live or live-attenuated vaccine within 30 days before first study dose
- Immunodeficiency diagnosis or ongoing systemic steroid therapy above 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first study dose
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years, except replacement therapies
- History or current pneumonitis/interstitial lung disease requiring steroids or active pneumonitis/interstitial lung disease
- Active infection needing systemic treatment
- Incomplete recovery from major surgery or ongoing surgical complications
- Any condition or situation that might interfere with study participation or results as judged by the investigator
- Psychiatric or social situations limiting compliance with study requirements
- Pregnancy, breastfeeding, or planning to conceive or father children during the study period
- History of allogenic tissue or solid organ transplant
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
K
Kristie Newsome
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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