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Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT04536077
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : March 2, 2021
Sponsor:
Collaborators:
Celldex Therapeutics
The Foundation for Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The central hypothesis is that the addition of CDX-301 to CDX-1140 radically improves anti-tumor immunity in patients with pancreatic ductal adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Cancer of the Pancreas Pancreas Cancer Drug: CDX-301 Drug: CDX-1140 Procedure: Research blood draw Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients
Actual Study Start Date : February 25, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CDX-1140 Monotherapy
Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.
Drug: CDX-1140
The drug will be supplied free of charge by Celldex

Procedure: Research blood draw
At screening; prior to first therapeutic dose of CDX-1140, on the day of the infusion; and at the time of surgery

Experimental: CDX-1140 + CDX-301
Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Drug: CDX-301
The drug will be supplied free of charge by Celldex

Drug: CDX-1140
The drug will be supplied free of charge by Celldex

Procedure: Research blood draw
At screening; prior to first therapeutic dose of CDX-1140, on the day of the infusion; and at the time of surgery




Primary Outcome Measures :
  1. Amount of intratumoral conventional dendritic cells between patients treated with CDX-1140 alone versus patients treated with CDX-301 plus CDX-1140 [ Time Frame: At time of surgery (estimated to be between day 8 and day 20) ]


Information from the National Library of Medicine

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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:

  • Histologically or cytologically confirmed surgically resectable pancreatic ductal adenocarcinoma, but not adenosquamous/squamous pancreas cancers (as determined by operating surgeon or tumor board).
  • At least 18 years of age.
  • ECOG performance status ≤ 1
  • Normal bone marrow and organ function as defined below:

    • Absolute neutrophil count ≥ 1,500 /cumm
    • Platelets ≥ 100,000 /cumm
    • Hemoglobin ≥ 9.0 g/dL
    • AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
    • Creatinine clearance ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL/min
    • INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
    • aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
    • Albumin ≥ 3.0mg/dL
  • The effects of CDX-301 and CDX-1140 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of either study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study or for 3 months after the last dose of either study drug, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Immune deficiencies such as HIV.
  • A history of other malignancy with the exception of malignancies for which all treatment was completed at least 2 years before registration and the patient has no evidence of disease.
  • Currently receiving any other investigational agents or has received any other investigational agents within 4 weeks or 5 half-lives of the planned first dose of study treatment.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-301 or CDX-1140 or other agents used in the study.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (for > 1 month of 10 mg prednisone daily, or equivalent) or any other form of immunosuppressive therapy not routinely associated with chemotherapeutic regimen.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, immunosuppression, autoimmune conditions, or underlying pulmonary disease.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, immunosuppression, autoimmune conditions, or underlying pulmonary disease.
  • Has an autoimmune disease requiring systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected).
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Has a known history of active TB (bacillus tuberculosis).
  • Major surgery within 28 days prior to the first study treatment.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • History of bone marrow or solid organ transplant.
  • Patients with a history of myocardial infarction, cerebral vascular accident, thrombosis or pulmonary embolus within 12 months prior to the first dose of study treatment are excluded from this study.
  • Patients with known mutations/amplifications in Flt3

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): NCT04536077


Contacts
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Contact: William G Hawkins, M.D. 314-362-7046 hawkinsw@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: William G Hawkins, M.D.    314-362-7046    hawkinsw@wustl.edu   
Principal Investigator: William G Hawkins, M.D.         
Sub-Investigator: David DeNardo, Ph.D.         
Sub-Investigator: Ryan Fields, M.D.         
Sub-Investigator: Kian-Huat Lim, M.D., Ph.D.         
Sub-Investigator: Manik Amin, M.D.         
Sub-Investigator: Olivia Aranha, M.D.         
Sub-Investigator: Nusayba Bagegni, M.D.         
Sub-Investigator: Salman Chaudhry, M.D.         
Sub-Investigator: Patrick Grierson, M.D.         
Sub-Investigator: Tanner Johanns, M.D., Ph.D.         
Sub-Investigator: Eric Knoche, M.D.         
Sub-Investigator: Haeseong Park, M.D.         
Sub-Investigator: Katrina Pedersen, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Benjamin Tan, M.D.         
Sub-Investigator: Nikolaos Trikalinos, M.D.         
Sub-Investigator: Liang Kiang, M.D., Ph.D.         
Sub-Investigator: Deyali Chatterjee, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Celldex Therapeutics
The Foundation for Barnes-Jewish Hospital
Investigators
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Principal Investigator: William G Hawkins, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04536077    
Other Study ID Numbers: 202011125
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
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
Product Manufactured in and Exported from the U.S.: No
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