New cocktail of drugs shows promise for tough pancreatic cancer
NCT ID NCT05014776
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of four drugs (tadalafil, pembrolizumab, ipilimumab, and CRS-207) in 17 people with advanced pancreatic cancer that had worsened after at least one round of chemotherapy. The goal was to see if the combination was safe and could shrink tumors. The approach aims to boost the immune system to fight the cancer, but this is not a cure and ongoing management is needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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17 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Three-Drug combo crack pancreatic Cancer's defenses?
- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
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- Can a new radiation machine cut breath holds for cancer patients?