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

Brief summary public domain (ClinicalTrials.gov)

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

Intervention public domain (ClinicalTrials.gov)

Drug: CDX-301. The drug will be supplied free of charge by Celldex

Intervention public domain (ClinicalTrials.gov)

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

Intervention public domain (ClinicalTrials.gov)

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

Arm public domain (ClinicalTrials.gov)

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.

Arm public domain (ClinicalTrials.gov)

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.

Primary outcome public domain (ClinicalTrials.gov)

Amount of Intratumoral Conventional Dendritic Cells (cDCs). Time frame: At time of surgery (estimated to be between day 8 and day 20).

Eligibility public domain (ClinicalTrials.gov)

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 …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 16 participants (actual).

Why stopped public domain (ClinicalTrials.gov)

Celldex decision

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Amount of Intratumoral Conventional Dendritic Cells (cDCs) [At time of surgery (estimated to be between day 8 and day 20)]. Mean, percentage of total cells (Standard Deviation). CDX-1140 Monotherapy (n=4): 0.9615 (0.3699); CDX-1140 + CDX-301 (n=4): 2.631 (0.8024).