Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Lustgarten Foundation
• Treatments: Ipilimumab; Pembrolizumab; Tadalafil

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Known history or evidence of brain metastases.

• Had chemotherapy, radiation, or biological cancer therapy within the last 14 days.

• Have received an investigational agent or device within the last 28 days.

• Had surgery within the last 28 days.

• Expected to require any other form of systemic or localized cancer therapy while on study.

• Have received a vaccine within the last 14 days (7 days for the COVID vaccine) or received a live vaccine within the last 30 days.

• Have received steroids within the last 14 days.

• Use more than 4 g/day of acetaminophen.

• Use of organic nitrates.

• Use of guanylate cyclase (GC) stimulators such as riociguat.

• Consumption of substantial amounts of alcohol (≥5 units/day)

• Use of strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitor or inducer.

• Patients on immunosuppressive agents within the last 7 days

• Known allergy to both penicillin and sulfa.

• Severe hypersensitivity reaction to any monoclonal antibody.

• History of severe hypersensitivity to tadalafil.

• Have implant(s) or device(s) that has not and cannot be easily removed.

• Have artificial joints or implanted medical devices that cannot be easily removed.

• Have any evidence of clinical or radiographic ascites.

• Have significant and/or malignant pleural effusion

• Uncontrolled intercurrent illness.

• Subjects with active, known or suspected autoimmune disease.

• Have a tissue or organ allograft, including corneal allograft.

• Have been diagnosed HIV, Hepatitis B or C positive.

• Is on supplemental home oxygen.

• Has an unhealed surgical wound or ulcer, or a bone fracture considered non-healing.

• Has clinically significant heart disease

• Prior history of non-arterial ischemic optic retinopathy.

• History of significant hypotensive episode requiring hospitalization within 6 months.

• Has insufficient peripheral vein access.

• Is unwilling or unable to follow the study schedule for any reason.

• Is pregnant or breastfeeding.