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Anti-tumor antibiotic, Anti-metabolites
Nivolumab + Chemotherapy for Pancreatic Cancer
Phase < 1
Recruiting
Led By Zev A Wainberg
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed pancreatic adenocarcinoma
Serum creatinine (sCr) =< 1.5 x ULN or creatinine clearance (Ccr) >= 40 mL/min as calculated by the modified Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for pancreatic cancer patients who are eligible for surgery. The hope is that the immunotherapy will help the body's immune system attack the cancer and make the surgery more successful.
Who is the study for?
This trial is for patients with a specific type of pancreatic cancer that might be removable by surgery. They should have good performance status, no prior treatments, and normal levels of blood cells and liver enzymes. People with advanced or metastatic disease, uncontrolled HIV or hepatitis B, recent serious heart issues, bleeding disorders, or women who are pregnant/nursing can't join.Check my eligibility
What is being tested?
The study tests how well nivolumab (an immune system-boosting drug) works with chemotherapy drugs like fluorouracil and oxaliplatin before surgery in treating pancreatic cancer. The goal is to see if this combination is more effective than chemotherapy alone in shrinking the tumor enough to allow for surgical removal.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, fatigue, nausea, diarrhea from chemotherapy drugs; also potential nerve damage leading to numbness or tingling sensations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of pancreatic cancer confirmed by tissue analysis.
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My kidney function, measured by creatinine levels, is within the required range.
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My condition is considered borderline operable.
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I am fully active or can carry out light work.
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My nerve damage does not severely affect my daily activities.
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I have not received any treatment for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically relevant pancreatic fistula in the post-operative period after neoadjuvant treatment with nivolumab and fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (FOLFIRINOX) (mFFX) chemotherapy
Pathologic complete response after nivolumab and mFFX treatment
Secondary outcome measures
Delayed wound healing
Disease free survival (DFS)
Incidence of adverse events
+5 moreOther outcome measures
Changes in immune cell infiltrates and cancer cell IFNgamma signaling in response to FOLFIRINOX and nivolumab treatment
Signaling and metabolomic changes in pancreatic ductal adenocarcinoma (PDAC) cancer cells that respond to IFNgamma
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, mFOLFIRINOX)Experimental Treatment8 Interventions
Patients receive nivolumab IV over 60 minutes on day 1. Patients also receive fluorouracil IV over 10 minutes and over 46 hours, irinotecan hydrochloride IV over 90-120 minutes, leucovorin calcium IV over 120 minutes, and oxaliplatin IV over 120 minutes on days 1 and 15. Treatments repeat every 28 days for 3-6 cycles in the absence of disease progression or unacceptable toxicity. Within 2-4 weeks after treatment, patients with resectable disease undergo surgery. Within 8-12 weeks after surgery, patients with successful resection may receive 6 additional cycles of fluorouracil, irinotecan hydrochloride, leucovorin calcium, and oxaliplatin in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Leucovorin Calcium
2011
Completed Phase 3
~12310
Nivolumab
2014
Completed Phase 3
~4750
Fluorouracil
2014
Completed Phase 3
~11540
Oxaliplatin
2011
Completed Phase 4
~2560
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
25,996 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,964 Total Patients Enrolled
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke, mini-stroke, or have carotid artery disease.I have no active cancer other than skin cancer (not melanoma) in the past 5 years.I have hepatitis B that has not been treated.My cancer is a type of pancreatic cancer confirmed by tissue analysis.My kidney function, measured by creatinine levels, is within the required range.I have not taken antibiotics or had an infection in the last 2 days.I do not have severe heart problems like recent heart attacks or uncontrolled heart rhythm issues.I am not pregnant or nursing, and if capable of bearing children, I test negative for pregnancy.My condition is considered borderline operable.I am fully active or can carry out light work.I have a blood clotting disorder but am on treatment without major bleeding recently.My nerve damage does not severely affect my daily activities.My cancer cannot be removed by surgery and has spread.I have not received any treatment for my condition.My HIV status is known and not well-controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, mFOLFIRINOX)
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.
What is the aggregate figure of participants enrolled in this experiment?
"Affirmative. Research collated on clinicaltrials.gov validates that this medical investigation, initially posted on 24th July 2019, is presently enlisting participants. A total of 36 volunteers will be accepted across one site."
Answered by AI
Are there other experiments involving Fluorouracil that have been completed?
"At the current moment, 1345 clinical trials related to Fluorouracil are in progress. Of those studies, 278 are Phase 3 and primarily located in Guangzhou, Guangdong. Simultaneously, 66206 sites worldwide have launched research initiatives revolving around this drug's efficacy."
Answered by AI
What is the most frequent purpose for which Fluorouracil is prescribed?
"Fluorouracil is primarily employed to address macrocytic anemia, but can also be beneficial for those with metastatic urothelial carcinoma of the ureter, requiring mineral supplementation therapy, and patients suffering from metastatic hepatocellular carcinoma."
Answered by AI
Are enrollees still being accepted into this clinical investigation?
"According to the clinicaltrials.gov database, enrollment for this investigation is ongoing since its initial posting on July 24th 2019 and last edited on May 11th 2022."
Answered by AI
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