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

Who is this study for? Patients with Pancreatic Cancer
What treatments are being studied? Tadalafil+Pembrolizumab+Ipilimumab+CRS-207
Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• Have histologically or cytologically proven adenocarcinoma of the pancreas.

• Have previously treated metastatic disease.

• Have radiographic disease progression.

• Patients with the presence of at least one measurable tumor lesion.

• Patient's acceptance to have a tumor biopsy at baseline and on

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.

• For both Women and Men, must use acceptable form of birth control while on study.

• Ability to understand and willingness to sign a written informed consent document.

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore
Time Frame
Start Date: 2022-08-22
Completion Date: 2025-04-03
Participants
Target number of participants: 17
Treatments
Experimental: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI), Lustgarten Foundation
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov