Neoadjuvant Cemiplimab in Stage I-II Merkel Cell Carcinoma: Safety and Biomarker Analysis
|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: NCT04975152|
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : August 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Merkel Cell Carcinoma||Drug: Cemiplimab-Rwlc||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Cemiplimab in Stage I-II Merkel Cell Carcinoma: Safety and Biomarker Analysis|
|Actual Study Start Date :||July 20, 2021|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2026|
Experimental: Neoadjuvant Cemiplimab Treatment
Participants will receive cemiplimab 350 mg IV at least 3 weeks prior to surgical resection. After surgery they will continue to receive 350 mg cemiplimab every 3 weeks for up to 8 additional doses.
Flat dose of cemiplimab-rwlc 350 mg IV every 3 weeks, up to 9 cycles.
Other Name: Libtayo
- Number of Participants With Adverse Events Related to Study Treatment [ Time Frame: Beginning of treatment to end of follow up, up to 3 years ]Number of participants with adverse events after receiving at least one dose of cemiplimab
- Relapse Free Survival [ Time Frame: Up to 3 years ]Relapse Free Survival (RFS) is defined as the time from study enrollment until disease recurrence or death.
- Overall Survival [ Time Frame: Up to 3 years ]Overall Survival (OS) is defined as the time from study enrollment until death.
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): NCT04975152
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Justin Martin 813-745-7544 Justin.Martin@moffitt.org|
|Principal Investigator: Ahmad Tarhini, MD, PhD|
|Sub-Investigator: Vernon Sondak, MD|
|Sub-Investigator: Nikhil Khushalani, MD|
|Sub-Investigator: Jonathan Zager, MD|
|Sub-Investigator: Zeynep Eroglu, MD|
|Sub-Investigator: Amod Sarnaik, MD|
|Sub-Investigator: Joseph Markowitz, MD, PhD|
|Sub-Investigator: Keiran Smalley, PhD|
|Sub-Investigator: Andrew Brohl, MD|
|Principal Investigator:||Ahmad Tarhini, MD, PhD||Moffitt Cancer Center|