Immunologic Effects Of CDX-301 And CDX-1140 In Resectable Pancreatic Cancer Patients

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-08-27	Results First Submitted 2024-08-30	Last Update Submitted that met QC Criteria 2024-09-30
First Submitted that Met QC Criteria 2020-08-27	Results First Submitted that Met QC Criteria 2024-09-30	Last Update Posted (ACTUAL) 2024-10-08
First Posted (ACTUAL) 2020-09-02	Results First Posted 2024-10-08	Last Verified 2024-09

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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	Measure Description	Time Frame
Amount of Intratumoral Conventional Dendritic Cells (cDCs)		At time of surgery (estimated to be between day 8 and day 20)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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).

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

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

Patients

Caregivers

Clinical Trial Record