Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT05014776
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tadalafil — DRUGPatients 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.
- Pembrolizumab — DRUGPatients 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.
- Ipilimumab — DRUGPatients 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.
- CRS-207 — DRUGPatients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 \[1 × 10\^9 colony forming units (CFU) in 100ml NS\] will be administered IV on Day 2 of Cycles 1-6.
Study Details
The purpose of this study is to evaluate the safety and clinical activity of tadalafil, pembrolizumab, ipilimumab, and CRS-207 in subjects with metastatic pancreatic adenocarcinoma who have progressed after at least 1 prior chemotherapy regimen.
Key Dates
- Start date
- Aug 22, 2022
- Status verified
- Apr 2026
- Primary completion
- Apr 3, 2024
- Completion
- Jun 19, 2025
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
Primary Outcome Measure
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [ Time Frame: 9 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | - |
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