Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma
ConditionMerkel Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have resectable stage I-III MCC.
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.
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.
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.
Disqualifiers
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.
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
A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
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).
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab
Drug400mg IV
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: PembrolizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
: Pathologic Response Rate
The number of subjects with pathologic complete response (CR) or near CR defined by less than 10% viable tumor cells will be determined for subjects who received 1 dose of neoadjuvant pembrolizumab and underwent definitive surgery. PathCR/nearCR rate is defined as the percentage of treated subjects who achieve PathCR/nearCR
Time frame
Approximately 3 weeksSecondary outcomes
1
Frequency and incidence of adverse events
Toxicity will be determined by scoring treatment-related AEs and SAEs. CTCAE version 5.0 grades will be employed.
Time frame
Up to 13 months2
Tumor infiltrating response (TIL)
Patients will be assessed for TIL response at the 3-week resection time point, with the resection tumor assessed for tumor-infiltrating lymphocytes by a board-certified pathologist. TIL response will be captured as a binary outcome that is either brisk TIL (diffuse lymphocytes throughout the tumor) or not (non-brisk TIL or absent TIL)
Time frame
Approximately 3 weeks3
Two Year Recurrence-Free Survival
Recurrence-free survival (RFS) is defined as the time from date of surgery to date of disease recurrence, death due to any cause or most recent follow-up documenting freedom from recurrence (i.e., scan date).
Time frame
Approximately 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov