Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer
|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: NCT04177810|
Recruitment Status : Not yet recruiting
First Posted : November 26, 2019
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Cemiplimab Drug: Plerixafor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2024|
Experimental: Cemiplimab and Plerixafor
All participants will receive Cemiplimab and Plerixafor.
Other Name: REGN-2810, Libtayo
Other Name: AMD3100, Mozobil
- Objective response rate (ORR) using immune RECIST (iRECIST) criteria [ Time Frame: 4 years ]ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
- Overall Response Rate (ORR) using RECIST 1.1 criteria [ Time Frame: 4 years ]Overall Response Rate (ORR) is the best response recorded from the start of the study treatment until the disease progression/recurrence based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Estimation based on the Kaplan-Meier curve.
- Number of participants experiencing grade 3 or above drug-related toxicities [ Time Frame: 4 years ]When calculating the incidence of adverse events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Estimation based on the Kaplan-Meier curve.
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): NCT04177810
|Contact: Susan Sartorius-Mergenthaler, RN||410-614-3644||Sartosu@jhmi.edu|
|Contact: Ellen Lilly-Forman, RNfirstname.lastname@example.org|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Dung Le, MD||Johns Hopkins Medical Institution|