Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil 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: NCT05014776|
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : June 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Tadalafil Drug: Pembrolizumab Drug: Ipilimumab Drug: CRS-207||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma|
|Estimated Study Start Date :||July 1, 2022|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
|Experimental: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207||
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6.
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6.
Other Name: KEYTRUDA®
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
Other Name: YERVOY®
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 [1 × 109 colony forming units (CFU) in 100ml NS] will be administered IV on Day 2 of Cycles 1-6.
- Objective response rate (irORR) using immune Response Evaluation Criteria for Solid Tumors (iRECIST) [ Time Frame: 4 years ]irORR is defined as the number of patients achieving a complete response (irCR) or partial response (irPR) based on the immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. irCR = disappearance of all target lesions, irPR is =>30percent decrease in sum of diameters of target lesions, progressive disease (irPD) is >20percent increase in sum of diameters of target lesions, stable disease (irSD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.
- Number of participants experiencing grade 3 or above drug-related toxicities [ Time Frame: 4 years ]When calculating the incidence of adverse event (AE)s, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
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): NCT05014776
|Contact: Trish Brothers, RN||410-614-3644||GIClinicalTrials@jhmi.edu|
|Contact: Joann Santmyer, RN||410-614-3644||GIClinicalTrials@jhmi.edu|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21231|
|Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu|
|Contact: Joann Santmyer, RN 410-614-3644 GIClinicalTrials@jhmi.edu|
|Principal Investigator: Katherine Bever, MD|
|Principal Investigator:||Katherine Bever, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution|