Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma (MCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05496036|
Recruitment Status : Not yet recruiting
First Posted : August 10, 2022
Last Update Posted : November 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma|
|Estimated Study Start Date :||January 1, 2023|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2026|
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.
Other Name: Keytruda
- : Pathologic Response Rate [ Time Frame: Approximately 3 weeks ]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
- Frequency and incidence of adverse events [ Time Frame: Up to 13 months ]Toxicity will be determined by scoring treatment-related AEs and SAEs. CTCAE version 5.0 grades will be employed.
- Tumor infiltrating response (TIL) [ Time Frame: Approximately 3 weeks ]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)
- Two Year Recurrence-Free Survival [ Time Frame: Approximately 2 years ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05496036
|Contact: Lydia Giles, BSN, RN||2156626389||Lydia.Giles@pennmedicine.upenn.edu|
|Contact: John Miura, MD||267-588-9179||John.Miura@Pennmedicine.upenn.edu|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Lydia Giles, BSN, RN 215-662-6389 Lydia.Giles@pennmedicine.upenn.edu|
|Principal Investigator:||John Miura, MD||Penn Medicine|