Pancreatic CancerPhase 2NCT05014776
Study of CRS-207, Pembrolizumab, Ipilimumab, and Tadalafil in Metastatic Pancreatic Cancer
A Phase 2 study testing Tadalafil, Pembrolizumab and Ipilimumab in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Tadalafil, Pembrolizumab and Ipilimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 19 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Tadalafil, Pembrolizumab, Ipilimumab, CRS-207
- Keywords
- Pancreatic cancer, Pembrolizumab, Ipilimumab, CRS-207, Tadalafil, Immunotherapy, Anti-PD-1, Anti-CTLA-4, Adenocarcinoma, Carcinoma
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TadalafilDrug
Also called CIALIS®
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.
PembrolizumabDrug
Also called KEYTRUDA®
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.
IpilimumabDrug
Also called YERVOY®
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.
CRS-207Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 | Experimental | Not described Receives: Drug: Tadalafil; Drug: Pembrolizumab; Drug: Ipilimumab; Drug: CRS-207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (1)
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start22 Aug 2022
- Primary completion3 Apr 2024
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Lustgarten Foundation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katherine Bever, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014776
- Sponsor's protocol ID
- J2180
- Other IDs
- IRB00291762, 5P01CA247886
- Status last verified
- Apr 2026
- First submitted
- 13 Aug 2021
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05014776
- Acronym / sponsor ID
- J2180
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Pembrolizumab, Ipilimumab, CRS-207, Tadalafil, Immunotherapy, Anti-PD-1, Anti-CTLA-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Lustgarten Foundation, National Cancer Institute (NCI)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 | Experimental | Drug: Tadalafil, Drug: Pembrolizumab, Drug: Ipilimumab, Drug: CRS-207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TadalafilAlso: CIALIS®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. | Drug | Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 |
| PembrolizumabAlso: KEYTRUDA®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. | Drug | Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 |
| IpilimumabAlso: YERVOY®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. | Drug | Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 |
| CRS-207Patients 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. | Drug | Arm A - Tadalafil, Pembrolizumab, Ipilimumab, CRS-207 |
Primary outcome
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.
1 secondary outcome
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Bever, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tadalafil, Pembrolizumab and Ipilimumab in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.