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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    20
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 20 September 2022
pancreatic adenocarcinoma
ipilimumab
cancer chemotherapy
adenocarcinoma
metastatic pancreatic cancer
metastatic pancreatic adenocarcinoma

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.

Details
Condition Pancreatic Cancer
Treatment Ipilimumab, Pembrolizumab, Tadalafil, CRS-207
Clinical Study IdentifierNCT05014776
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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