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Chemotherapy
Chemotherapy + Immunotherapy for Pancreatic Cancer
Phase 2
Recruiting
Led By Ernest R. Camp, M.D., M.S.C.R., F.A.C.S.
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior mesenteric vein/portal vein (SMV/PV) with < 180-degree abutment and no evidence of invasion.
Patient must not have received prior chemotherapy or radiation for pancreatic cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new combination treatment for pancreatic cancer. Patients will receive neoadjuvant FOLFIRINOX (a chemotherapy regimen) combined with pembrolizumab (a immunotherapy) followed by surgery. The trial will enroll 30 patients and will last for 3.5 years.
Who is the study for?
This trial is for adults with a specific type of pancreatic cancer that can potentially be removed by surgery. They should not have had previous chemotherapy or radiation, must be in good physical condition (ECOG PS 0-1), and have normal organ function. Women of childbearing age must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The study is testing the combination of Folfirinox (a mix of chemotherapy drugs) with Pembrolizumab, an immunotherapy drug, given before surgery to remove the cancer. This Phase II trial will compare results against past data from similar patients who didn't receive this combo treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs, infusion-related reactions from the drug entering your body, fatigue, nausea or vomiting due to chemo drugs, blood cell count changes increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to major arteries or veins near my liver.
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I have not had chemotherapy or radiation for pancreatic cancer.
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My liver is functioning properly.
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My main abdominal veins are open and not blocked.
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My kidney function is within the required range.
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I am over 18 and have a type of pancreatic cancer that can potentially be surgically removed.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine or GFR, is within the required range.
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My cancer has not spread to the celiac axis or hepatic artery.
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My cancer has not spread to distant parts of my body.
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I agree to follow the study's rules for using contraception and not donate sperm for a specified time after the last dose.
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I am a male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine if the neoadjuvant FOLFIRINOX chemotherapy followed by pembrolizumab followed by surgery will improve the overall response rate (ORR) for patients with localized, resectable adenocarcinoma of the pancreas.
Secondary outcome measures
Determine if the addition of pembrolizumab to neoadjuvant mFOLFIRINOX leads to improved CD8+ T cell frequencies in resected tumor samples in comparison to archived matched controls from patients meeting the same I/E criteria as those in the study.
Estimate the effect of combination neoadjuvant therapy on the R0 resection rate
Estimate the effect of combined neoadjuvant therapy on relapse-free survival, time to recurrence and overall survival.
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Folfirinox and Pembrolizumab followed by sx for patients with pancreatic cancerExperimental Treatment2 Interventions
Patients will receive 6 cycles of Folfirinox (Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2,400 mg/m2) with 2 cycles of Pembrolizumab 400 mg before surgical resection. Following surgery patients will receive 5-Fluorouracil based chemotherapy for up to 6 cycles with 7 more cycles of Pembrolizumab. Patients will receive a total of 9 doses of Q6week cycles of Pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Folfirinox
2018
Completed Phase 3
~760
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,222 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,345 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,053 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with specific immune therapy drugs before.I am not on high-dose steroids or other drugs that weaken my immune system.I have a history of Hepatitis B or active Hepatitis C.My liver is functioning properly.My main abdominal veins are open and not blocked.I experience significant numbness, pain, or weakness in my hands or feet.My kidney function is within the required range.I am over 18 and have a type of pancreatic cancer that can potentially be surgically removed.My blood clotting time is normal or managed with medication.I have or had lung inflammation not caused by infection, treated with steroids.I have received an organ or tissue transplant from another person.My blood counts are within normal ranges.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well, as confirmed by recent tests.My kidney function, measured by creatinine or GFR, is within the required range.I am a woman who can have children and have a recent negative pregnancy test.I have not had major surgery in the last 4 weeks.My cancer has not spread to the celiac axis or hepatic artery.My cancer has not spread to distant parts of my body.I am over 80 but fit for chemotherapy and surgery.There should be a visible separation between the SMA (superior mesenteric artery) and celiac axis (artery).I am not pregnant or have confirmed it with a test before starting the treatment.I have not received a live vaccine in the last 30 days.I am not pregnant, not breastfeeding, and meet one of the specific conditions listed.I agree to follow the study's rules for using contraception and not donate sperm for a specified time after the last dose.I have not had active treatment for another cancer, except for certain skin cancers or localized cancers, in the past 2 years.I have not had serious heart problems in the last year.My cancer has not spread to major arteries or veins near my liver.I have not had chemotherapy or radiation for pancreatic cancer.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I do not have any active infections needing treatment.My cancer is advanced but hasn't spread widely and isn't one of the excluded types.I am HIV positive.I am willing and able to follow the study's procedures.I have a health condition that makes receiving chemotherapy or radiation unsafe.I am a male.My blood clotting function is normal.My cancer is in one area and might be removable by surgery.I am allergic to the medication used in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant Folfirinox and Pembrolizumab followed by sx for patients with pancreatic cancer
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.
Has the U.S. Food and Drug Administration given its blessing to Pembrolizumab?
"Drawing from the evidence available, our team has assigned a risk score of 2 to Pembrolizumab. This is because Phase 2 trials have only produced safety data and not efficacy results."
Answered by AI
What conditions are typically treated with Pembrolizumab?
"Pembrolizumab has been established to be a viable treatment option for malignant neoplasms, unresectable melanomas and cases of microsatellite instability high."
Answered by AI
Have there been any other investigations undertaken with regards to Pembrolizumab?
"As of the present, there are 961 clinical trials in progress concerning Pembrolizumab. 122 of those investigations have reached Stage 3 and many are based out of Houston, Texas; however, 35731 other sites across the world host studies for this treatment."
Answered by AI
What is the current enrollment number for this clinical experiment?
"Affirmative. According to the clinicaltrials.gov website, this trial is still recruiting participants after initially being posted on August 31st 2022 and subsequently updated September 1st 2022. This study requires 30 volunteers from 2 sites in order to be completed satisfactorily."
Answered by AI
Are there any prospective participants for this clinical research project?
"As per the information hosted on clinicaltrials.gov, this medical study is actively seeking participants for enrollment. The trial was initially announced on August 31st 2022 and most recently revised on September 1st of that same year."
Answered by AI
What is the ultimate aim of this research endeavor?
"Merck Sharp & Dohme LLC, the trial sponsor for this study, has identified improved CD8+ T cell frequencies over a 3 year period as its primary outcome measure. Secondary objectives include an assessment of descriptive statistics and group comparison of CD8+T cells frequencies; estimation of R0 resection rate with 95% confidence interval; and evaluation of relapse-free survival, time to recurrence, and overall survival using 95% confidence intervals."
Answered by AI
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