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

April 8, 2026 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
Drug: Tadalafil
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6.
Other Names:
  • CIALIS®
Drug: Pembrolizumab
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6.
Other Names:
  • KEYTRUDA®
Drug: Ipilimumab
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
Other Names:
  • YERVOY®
Drug: CRS-207
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 [1 × 10^9 colony forming units (CFU) in 100ml NS] will be administered IV on Day 2 of Cycles 1-6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Time Frame: 9 months
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.
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)
Lustgarten Foundation

Investigators

  • Principal Investigator: Katherine Bever, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2022

Primary Completion (Actual)

April 3, 2024

Study Completion (Actual)

June 19, 2025

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J2180
  • 5P01CA247886 (U.S. NIH Grant/Contract)
  • IRB00291762 (Other Identifier: Johns Hopkins Medical Institution)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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