Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT05496036
Phase
PHASE2
Status
Recruiting
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Conditions

  • Merkel Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    400mg IV

Study Details

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.

Key Dates

Start date
Feb 13, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Study participants will undergo a tumor tissue collection biopsy prior to treatment, followed by one dose of pembrolizumab 400mg, then undergo a curative intent resection of all remaining disease 3 weeks after the initial dose of pembrolizumab. Post-operatively, subjects will receive up to 1 year of pembrolizumab 400mg every 6 weeks.

Primary Outcome Measure

: Pathologic Response Rate [ Time Frame: Approximately 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn MedicinePhiladelphiaPennsylvania19104
Lydia Giles, BSN, RN
[email protected]
2156626389

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By research site
Penn Medicine· Philadelphia, PA

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