Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer (NCT05014776) | Clinical Trial Compass
CompletedPhase 2
Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer
United States17 participantsStarted 2022-08-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
*…
What they're measuring
1
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Timeframe: 9 months
Trial details
NCT IDNCT05014776
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins