Chemotherapy + Immunotherapy for Pancreatic Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byErnest R. Camp, M.D., M.S.C.R., F.A.C.S.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Baylor College of Medicine
Must not be taking: Immunosuppressants, Steroids
Disqualifiers: HIV, Cardiovascular disease, Autoimmune, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This trial tests a combination of chemotherapy and immune therapy for patients with a specific type of pancreatic cancer. The goal is to improve surgery outcomes by shrinking the tumor and boosting the body's ability to fight cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have received certain treatments like live vaccines recently, you may need to adjust your medications. It's best to discuss your specific situation with the trial team.
What data supports the effectiveness of the treatment FOLFIRINOX for pancreatic cancer?
What safety data exists for FOLFIRINOX in treating pancreatic cancer?
How is the chemotherapy and immunotherapy treatment for pancreatic cancer different from other treatments?
This treatment combines FOLFIRINOX, a chemotherapy regimen known for its effectiveness but also higher toxicity, with Pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells. This combination aims to enhance treatment effectiveness by using both chemotherapy and the body's immune response, which is a novel approach compared to standard chemotherapy alone.15101112
Eligibility Criteria
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.Inclusion Criteria
My liver is functioning properly.
My main abdominal veins are open and not blocked.
- Absolute neutrophil count (ANC) ≥1500/μL
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Exclusion 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.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Chemotherapy
Participants receive 6 cycles of FOLFIRINOX and 2 cycles of Pembrolizumab before surgical resection
12 weeks
Surgery
Surgical resection of the pancreatic tumor
1 week
Adjuvant Chemotherapy
Participants receive 5-Fluorouracil based chemotherapy for up to 6 cycles with 7 more cycles of Pembrolizumab
54 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
16 weeks
Treatment Details
Interventions
- Folfirinox (Chemotherapy)
- Pembrolizumab (PD-1 Inhibitor)
Trial OverviewThe 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.
Participant Groups
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.
Folfirinox is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as FOLFIRINOX for:
- Pancreatic cancer
🇪🇺 Approved in European Union as FOLFIRINOX for:
- Pancreatic cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
Baylor St. Luke's Medical Center (BSLMC).Houston, TX
Houston Methodist HospitalHouston, TX
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Who Is Running the Clinical Trial?
Baylor College of MedicineLead Sponsor
The Methodist Hospital Research InstituteCollaborator
Merck Sharp & Dohme LLCIndustry Sponsor
References
Defining Eligibility of FOLFIRINOX for First-Line Metastatic Pancreatic Adenocarcinoma (MPC) in the Province of British Columbia: A Population-based Retrospective Study. [2018]FOLFIRINOX is a first-line treatment option for patients with metastatic pancreatic cancer (MPC) and is associated with improved survival yet significantly more toxicities than standard gemcitabine. Our aim was to determine the proportion of patients with MPC who would be eligible for FOLFIRINOX based upon the pivotal ACCORD study criteria.
Pancreatic cancer and FOLFIRINOX: a new era and new questions. [2023]FOLFIRINOX (FFX) was introduced to clinical practice in 2010 following publication of the PRODIGE 4/ACCORD 11 study, which compared this novel regimen to gemcitabine in metastatic pancreatic cancer. Median overall survival, progression-free survival, and objective responses were all superior with FFX and there was improved time to definitive deterioration in quality of life. Despite initial concerns over toxicity, there has been rapid uptake of this regimen, both revolutionizing management and opening the door to innovative research. As experience with FFX has accrued, many questions have arisen including the management of toxicities, the impact of frequent modifications, the optimal number of cycles, integration with other regimens and modalities, interpretation of radiologic and serologic response, utility of molecular signatures, and potential benefit in unique clinical settings such as pre- and postsurgery. This review will closely examine these issues, not only to summarize current knowledge but also to fuel scientific debate.
Alterations in regulatory T cells and immune checkpoint molecules in pancreatic cancer patients receiving FOLFIRINOX or gemcitabine plus nab-paclitaxel. [2022]This pilot study aimed on generating insight on alterations in circulating immune cells during the use of FOLFIRINOX and gemcitabine/nab-paclitaxel in pancreatic ductal adenocarcinoma (PDAC).
Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden. [2023]Pembrolizumab confers minimal benefit to most patients with pancreas cancer. We explored survival and patient treatment burden (for example, death within 14 days of therapy) in a subgroup who had early access to pembrolizumab .
Current status on the place of FOLFIRINOX in metastatic pancreatic cancer and future directions. [2021]Pancreatic cancer (PC) incidence rates are rapidly increasing in developed countries, with half the patients being metastatic at diagnosis. For decades, fluorouracil, then gemcitabine regimens were the preferred palliative first-line options for fit patients with metastatic PC. FOLFIRINOX (a combination of bolus and infusional fluorouracil, leucovorin, irinotecan and oxaliplatin) was introduced to clinical practice in 2010 due to the results of the phase II/III trial (PRODIGE 4/ACCORD 11) comparing FOLFIRINOX with single-agent gemcitabine as first-line treatment for patients with MPC. Median overall survival, progression-free survival, and objective response rate were superior with FOLFIRINOX over gemcitabine and there was prolonged time to definitive deterioration in quality of life. Although FOLFIRINOX was also associated with increased toxicity, mainly febrile neutropenia and diarrhea, there has been rapid uptake of this regimen. This review closely examines optimal management and prevention of toxicities, international recommendations for first-line treatment, and use of modified FOLFIRINOX protocols. In this review, we also look at the potential benefit of FOLFIRINOX in selected groups of patients: second-line therapy, adjuvant chemotherapy, induction therapy in patients with borderline resectable and locally advanced PC. Robust validation of the FOLFIRINOX regimen in these settings requires confirmation in further randomized trials.
Equivalent Efficacy but Different Safety Profiles of Gemcitabine Plus Nab-Paclitaxel and FOLFIRINOX in Metastatic Pancreatic Cancer. [2022]FOLFIRINOX (FFX) and gemcitabine + nab-paclitaxel (GN) are the most common chemotherapy regimens in first-line treatment of metastatic pancreatic cancer (PC). They have not been compared each other in a prospective trial, but only in retrospective studies, which can thus be affected by several biases. In order to overcome these biases, we took advantage of matching-adjusted indirect comparison (MAIC), that allows an indirect comparison by reducing cross-trial differences, and compared data from 268 patients treated with GN in a real-world setting with data from the 171 patients included in the FFX arm of the PRODIGE trial. Survival outcomes did not differ between the two populations. Overall survival was 11.1 months for both treatments (hazard ratio (HR) of FFX 1.10, 95% confidence interval (CI) 0.81-1.49; p = 0.527). Progression-free survival was 6.0 months with GN and 6.4 months with FFX (HR of FFX 1.11, 95% CI 0.82-1.50; p = 0.520). On the other hand, we observed a difference in the toxicity profiles: grade 3/4 anemia was more frequent with GN, whereas a higher occurrence of grade 3/4 vomiting and diarrhea was reported with FFX. FFX and GN show an equivalent efficacy but different safety profiles in the first-line therapy of metastatic pancreatic cancer. Searching for reliable predictive biomarkers is advised in order to improve therapeutic strategy in metastatic PC.
Safety and efficacy of second-line treatment with folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) in combination of panitumumab and bevacizumab for patients with metastatic colorectal cancer. [2021]We investigated the efficacy and safety of a new second-line chemotherapy of combining folinic acid, 5-fluorouracil and irinotecan (FOLFIRI) with both panitumumab and bevacizumab to treat patients with metastatic colorectal cancer (mCRC). Patients with mCRC and unsuccessful previous oxaliplatin-based chemotherapy were included in the study. The FOLFIRI arm was given FOLFIRI only. The FOLFIRI+PB arm was given panitumumab (3 mg/kg) and bevacizumab (3 mg/kg) plus FOLFIRI every other week. Between 2009 and 2013, 155 and 137 patients were included in the FOLFIRI arm and FOLFIRI+PB arm, respectively. The response rate was 40.1 % for FOLFIRI+PB arm versus 30.1 % for FOLFIRI arm. The disease-controlled rate in FOLFIRI+PB arm was improved to 62.2 from 50.2 % in FOLFIRI arm. The median overall survival was 13.9 months in FOLFIRI+PB arm as compared to 10.7 months in FOLFIRI arm. A series of adverse events were comparable between two arms, whereas some of the antibody therapy-associated toxicities were observed in FOLFIRI+PB arm. The new strategy of combining panitumumab and bevacizumab with FOLFIRI as second-line chemotherapy for patients with mCRC is safe and feasible.
Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. [2020]To evaluate the efficacy and safety of modified FOLFIRINOX as a second-line treatment for gemcitabine (GEM)-refractory unresectable pancreatic cancer (PC).
FOLFIRINOX relative dose intensity and disease control in advanced pancreatic adenocarcinoma. [2022]Most patients with advanced pancreatic adenocarcinoma (PA) treated with FOLFIRINOX experience adverse events requiring dose reduction. We aimed to assess the association between relative dose intensity (RDI) and disease control in a European setting.
Sequential first-line treatment with nab-paclitaxel/gemcitabine and FOLFIRINOX in metastatic pancreatic adenocarcinoma: GABRINOX phase Ib-II controlled clinical trial. [2022]Nab-paclitaxel/gemcitabine (AG) and FOLFIRINOX (FFX) are promising drugs in metastatic pancreatic cancer (MPC). This study evaluated a new first-line sequential treatment (AG followed by FFX) in MPC that might overcome resistance to primary therapy and delay tumor progression.
Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis. [2022]FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, oxaliplatin) and gemcitabine plus nab-paclitaxel therapy have recently been introduced for the treatment of metastatic pancreatic cancer. Herein, overall treatment outcomes of metastatic pancreatic cancer after introduction of FOLFIRINOX and gemcitabine plus nab-paclitaxel therapy were evaluated, in daily practice.
Comparison of FOLFIRINOX vs Gemcitabine Plus Nab-Paclitaxel as First-Line Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma. [2023]FOLFIRINOX (leucovorin calcium [folinic acid], fluorouracil, irinotecan hydrochloride, and oxaliplatin) and gemcitabine plus nab-paclitaxel are the 2 common first-line therapies for metastatic adenocarcinoma of the pancreas (mPC), but they have not been directly compared in a clinical trial, and comparative clinical data analyses on their effectiveness are limited.