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Immunomodulator
CDX-301 + CDX-1140 Immunotherapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Roheena Z Panni, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance ≤ 1.5 x IULN or glomerular filtration rate of ≥ 60 mL/min
At least 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of surgery (estimated to be between day 8 and day 20)
Awards & highlights
Study Summary
This trial is testing whether adding CDX-301 to CDX-1140 improves the effectiveness of the immunotherapy drug in people with pancreatic cancer.
Who is the study for?
This trial is for adults with resectable pancreatic cancer who haven't had chemotherapy in the past 2 weeks or major surgery within the last month. They must have good organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception, and can't have immune deficiencies like HIV, autoimmune diseases treated in the last 2 years, a recent history of serious cardiovascular events, or known mutations in Flt3.Check my eligibility
What is being tested?
The study tests whether adding CDX-301 to CDX-1140 boosts anti-tumor immunity in patients with operable pancreatic ductal adenocarcinoma. Participants will receive both drugs before their cancer surgery and researchers will monitor how this combination affects their immune system's ability to fight cancer.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as flu-like symptoms (fever, chills), fatigue, possible allergic reactions similar to other compounds like CDX-301 or CDX-1140. The exact side effects are unknown since these drugs are being researched.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of surgery (estimated to be between day 8 and day 20)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery (estimated to be between day 8 and day 20)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount of intratumoral conventional dendritic cells (cDCs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: CDX-1140 MonotherapyExperimental Treatment2 Interventions
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 II: CDX-1140 + CDX-301Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-301
2017
Completed Phase 1
~170
Research blood draw
2022
Completed Phase 2
~240
CDX-1140
2017
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,933 Previous Clinical Trials
2,299,709 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
61 Previous Clinical Trials
3,934 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,473 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cancer is confirmed and considered operable, not treated with chemotherapy in the last 6 months.My blood clotting time is normal or managed with medication.I agree to use birth control or abstain from sex during and for 3 months after the study.My kidney function is within the normal range.I can understand and am willing to sign the consent form.My blood clotting time is within a safe range, even if I'm on blood thinners.I have not had major surgery in the last 28 days.I do not have any serious ongoing illnesses like heart problems or infections.I have had a bone marrow or organ transplant.You have a history of hepatitis B or active hepatitis C virus.I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.I haven't had chemotherapy in the last 2 weeks.You have a weakened immune system, such as from HIV.I do not have any ongoing serious illnesses like infections or autoimmune diseases.My cancer has Flt3 mutations.I have not had a heart attack, stroke, clot, or lung blockage in the last year.I have had pneumonitis treated with steroids or have it now.Your albumin level in your blood is at least 3.0mg/dL.I am fully active and can carry on all my pre-disease activities without restriction.My blood tests for bone marrow and organ function are normal.Your platelet count is at least 100,000 per cubic millimeter.Your hemoglobin level must be 9.0 grams per deciliter or higher.Your liver enzymes (AST and ALT) are not more than 2.5 times the upper limit of normal.You have enough white blood cells called neutrophils.I am 18 years old or older.I have an active tuberculosis infection.You have had allergic reactions to drugs similar to CDX-301 or CDX-1140.I have an immune system disorder or have been on long-term steroids or other drugs that weaken my immune system.I have been treated for an autoimmune disease with strong medication in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-1140 Monotherapy
- Group 2: CDX-1140 + CDX-301
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any subjects currently enrolled in this investigation?
"As reported on clinicaltrials.gov, this investigation is currently recruiting participants and was initially posted on February 25th 2021. The study has been updated most recently on November 3rd 2022."
Answered by AI
How widespread is the participation in this research experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this investigation is open to new patients, having been posted on February 25th 2021 and last refreshed November 3rd 2022. The trial requires 24 individuals from one test location."
Answered by AI
Has the FDA granted clearance to CDX-1140?
"Our team at Power gave CDX-1140 a score of 2 to indicate that while there is some evidence verifying its safety, the absence of data supporting efficacy means it cannot be rated higher."
Answered by AI
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