Actively Recruiting
Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-02-18
15
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main purpose of this study is to determine the response of Merkel cell carcinoma to pembrolizumab before surgery and to determine whether it further reduces the risk for disease recurrence. Another purpose of this study is to look at the side effects that occur when the experimental drug pembrolizumab is given to people with Merkel cell carcinoma before and after their standard of care surgery to remove the Merkel cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have resectable stage I-III Merkel cell carcinoma
- Expected to have enough tumor for 2-4 pre-operative biopsy samples plus diagnostic tissue
- Expected to have enough residual tumor after pre-operative biopsy to obtain 4-6 additional biopsy samples at surgery
- Willing to undergo paired tumor biopsies for biomarker studies with tissue not previously irradiated
- Male participants must use contraception during treatment and for at least 120 days after last dose and avoid sperm donation
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to use contraception during treatment and for at least 120 days after last dose
- Provided archival tumor tissue or newly obtained biopsy of tumor not previously irradiated
- Have an ECOG performance status of 0 to 1
- Have adequate organ function
- Participants with hepatitis B are eligible if on antiviral therapy with undetectable viral load prior to randomization and will continue antiviral therapy during study
- Participants with hepatitis C are eligible if viral load is undetectable and curative antiviral therapy completed at least 4 weeks prior to randomization
You will not qualify if you...
- Have unresectable disease that cannot be completely removed with clear margins
- Have not recovered adequately from major surgery or surgical complications before starting study treatment
- Female of childbearing potential with positive pregnancy test within 72 hours prior to allocation
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or related immunotherapies
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before allocation
- Prior radiotherapy within 2 weeks before study treatment start unless palliative radiation with 1-week washout
- Received live or live-attenuated vaccine within 30 days before first dose; killed vaccines allowed
- Participation in other investigational studies or use of investigational devices within 4 weeks before first dose
- Diagnosis of immunodeficiency or receiving systemic steroid therapy over 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first dose
- Other active malignancies progressing or requiring treatment within past 3 years, except certain skin cancers treated curatively
- Active central nervous system metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids or active disease
- Active infections needing systemic therapy
- Known HIV infection
- Concurrent active hepatitis B and hepatitis C infection
- Conditions or treatments that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or expecting to conceive or father children during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Penn Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
L
Lydia Giles, BSN, RN
CONTACT
J
John Miura, MD
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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