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

NCT04536077 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2020111251R01CA262506
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Amount of Intratumoral Conventional Dendritic Cells (cDCs)

  At time of surgery (estimated to be between day 8 and day 20)

Study Arms (2)

CDX-1140 Monotherapy

EXPERIMENTAL

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; Procedure: Research blood draw

CDX-1140 + CDX-301

EXPERIMENTAL

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; Drug: CDX-1140; Procedure: Research blood draw

Interventions

CDX-301 DRUG

The drug will be supplied free of charge by Celldex

CDX-1140 + CDX-301

CDX-1140 DRUG

The drug will be supplied free of charge by Celldex

CDX-1140 + CDX-301; CDX-1140 Monotherapy

Research blood draw 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; CDX-1140 Monotherapy

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Celldex Therapeutics: collaborator
• The Foundation for Barnes-Jewish Hospital: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Roheena Z. Panni, M.D.
• Organization: Washington University School of Medicine

roheenazpanni@wustl.edu

314-362-7046

Study Officials

• Roheena Z Panni, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: August 13, 2021
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)