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

NCT ID: NCT04536077

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2023-11-21

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.

Conditions

Pancreatic Cancer; Cancer of the Pancreas; Pancreas Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CDX-1140

Intervention Type: DRUG

The drug will be supplied free of charge by Celldex

Research blood draw

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

CDX-301

Intervention Type: DRUG

The drug will be supplied free of charge by Celldex

CDX-1140

Intervention Type: DRUG

The drug will be supplied free of charge by Celldex

Research blood draw

Intervention Type: PROCEDURE

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

Interventions

CDX-301

The drug will be supplied free of charge by Celldex

Intervention Type: DRUG

CDX-1140

The drug will be supplied free of charge by Celldex

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

Eligibility 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). Patients who have previously received chemotherapy for his/her pancreas cancer within the past 6 months and who are now deemed resectable are also eligible for this trial.
• 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.
• Receipt of chemotherapy within 2 weeks of 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celldex Therapeutics

INDUSTRY

Sponsor Role: collaborator

The Foundation for Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roheena Z Panni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

1R01CA262506

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202011125

Identifier Type: -

Identifier Source: org_study_id