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

NCT05014776 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: J2180IRB002917625P01CA247886
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer; Pembrolizumab; Ipilimumab; CRS-207; Tadalafil; Immunotherapy; Anti-PD-1; Anti-CTLA-4; Adenocarcinoma; Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)

  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 Outcomes (1)

• Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation

  9 months

Study Arms (1)

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

EXPERIMENTAL

Drug: Tadalafil; Drug: Pembrolizumab; Drug: Ipilimumab; Drug: CRS-207

Interventions

Tadalafil DRUG

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.

Also known as: CIALIS®

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

Pembrolizumab DRUG

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.

Also known as: KEYTRUDA®

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

Ipilimumab DRUG

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.

Also known as: YERVOY®

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

CRS-207 DRUG

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.

Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lustgarten Foundation: collaborator
• National Cancer Institute (NCI): collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma; Carcinoma

Interventions

Tadalafil; pembrolizumab; Ipilimumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Katherine Bever, MD
• Organization: SKCCC Johns Hopkins Medical Institution

kbever1@jhmi.edu

443-287-0966

Study Officials

• Katherine Bever, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: August 22, 2022
• Primary Completion: April 3, 2024
• Study Completion: June 19, 2025
• Last Updated: April 28, 2026
• Results First Posted: January 30, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)