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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014776
Recruitment Status : Recruiting
First Posted : August 20, 2021
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Lustgarten Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Tadalafil Drug: Pembrolizumab Drug: Ipilimumab Drug: CRS-207 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

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 Name: 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 Name: 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 × 109 colony forming units (CFU) in 100ml NS] will be administered IV on Day 2 of Cycles 1-6.


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (irORR) using immune Response Evaluation Criteria for Solid Tumors (iRECIST) [ Time Frame: 4 years ]
    irORR is defined as the number of patients achieving a complete response (irCR) or partial response (irPR) based on the immune Response Evaluation Criteria in Solid Tumors (iRECIST) at any time during the study. irCR = disappearance of all target lesions, irPR is =>30percent decrease in sum of diameters of target lesions, progressive disease (irPD) is >20percent increase in sum of diameters of target lesions, stable disease (irSD) is <30percent decrease or <20percent increase in sum of diameters of target lesions.


Secondary Outcome Measures :
  1. Number of participants experiencing grade 3 or above drug-related toxicities [ Time Frame: 4 years ]
    When calculating the incidence of adverse event (AE)s, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014776


Contacts
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Contact: Trish Brothers, RN 410-614-3644 GIClinicalTrials@jhmi.edu
Contact: Joann Santmyer, RN 410-614-3644 GIClinicalTrials@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Contact: Trish Brothers, RN    410-614-3644    GIClinicalTrials@jhmi.edu   
Contact: Joann Santmyer, RN    410-614-3644    GIClinicalTrials@jhmi.edu   
Principal Investigator: Katherine Bever, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lustgarten Foundation
Investigators
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Principal Investigator: Katherine Bever, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Institution
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT05014776    
Other Study ID Numbers: J2180
IRB00291762 ( Other Identifier: Johns Hopkins Medical Institution )
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Pancreatic cancer
Pembrolizumab
Ipilimumab
CRS-207
Tadalafil
 Immunotherapy
Anti-PD-1
Anti-CTLA-4
Adenocarcinoma
Carcinoma
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Ipilimumab
 Tadalafil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents