Could keytruda before surgery keep merkel cell cancer away?
NCT ID NCT05496036
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether the immunotherapy drug pembrolizumab (Keytruda) can shrink Merkel cell carcinoma before surgery and lower the risk of it returning afterward. About 15 people with stage I to III Merkel cell carcinoma that can be surgically removed will receive one dose of pembrolizumab before surgery, then more doses after. Researchers will measure how many patients have a complete or near-complete response in the tumor tissue removed during surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pembrolizumab (Keytruda)
- What this could lead to
- If successful, this approach could lower the chance of Merkel cell carcinoma coming back after surgery.
- What could go wrong
- This is a small, early-phase trial with only 15 participants, so results may not apply broadly. Side effects from pembrolizumab are possible, and the treatment may not improve outcomes.
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.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Sep 2027
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. Must have resectable stage I-III MCC. 2. Must be expected to have an adequate amount of tumor burden to yield 2-4 pre-operative research core biopsy (14-gauge needle) specimens or the equivalent amount of tissue (4-6 mm punch biopsy), in addition, to the tissue required for diagnostic purposes. For stage III MCC patients, assessment of measurable disease/tumor burden will be determined by tumor imaging and reviewed by the treatment team. 3. Must be expected to have an adequate amount of residual tumor after their pre-operative research tumor tissue collection, such that their operative research tumor collection will also yield at least 4-6 research core biopsy specimens or the equivalent amount of tissue. 4. Must be willing to undergo the two paired tumor tissue biopsy procedures to obtain samples for biomarker analysis. Tissue obtained must not be previously irradiated. 5. Male subjects must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. 6. Female subjects must not be pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. 7. Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 9. Have adequate organ function. 10. Hepatitis B (HBV) positive subjects * Subjects who is HBsAg positive is eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. * Subject should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 11. Subject with history of Hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening. Subject must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Exclusion Criteria: 1. Have unresectable disease; i.e. in the opinion of the surgical oncologist, all of the subject's MCC cannot be completely removed with a clear margin. 2. If the subject had major surgery, the subject must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention 3. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. 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 systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation. 6. Has received prior radiotherapy within 2 weeks of start of study intervention. Subject must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. 7. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 8. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 9. 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. 10. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Subject with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. 11. Has known active CNS metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. 12. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 13. 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 and is allowed. 14. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 15. Has an active infection requiring systemic therapy. 16. Has a known history of Human Immunodeficiency Virus (HIV) infection. 17. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. 18. 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. 19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 20. 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. 21. Has had an allogenic tissue/solid organ transplant.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Penn Medicine
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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