Clinical trial · Interventional
Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer
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
NCT05014776CI-TRIAL-00109654completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS-207 | Drug | — | UNRESOLVED |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Tadalafil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
- interventionNames
- Drug: Tadalafil
- Drug: Pembrolizumab
- Drug: Ipilimumab
- Drug: CRS-207
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
- timeFrame
- 9 months
- description
- Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.