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New treatment option for Pancreatic Cancer
Official title Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
ClinicalTrials.gov ID: NCT05462496
What this study is testing
What is FOLFIRINOX?
FOLFIRINOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Also referred to as Chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Histologically confirmed pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible. \ Note...
- Clinical stage T1-3, N0-2, M0 (per AJCC 8th ed)
- Resectable pancreatic cancer as defined by NCCN Guidelines 2.2021 and based on pancreatic protocol dual-phase CT imaging. Multi-detector computed...
- No arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA])
- No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity
You likely can't join if
- Borderline resectable, locally advanced or distant metastatic disease
- Any medical condition which makes definitive surgical resection of the pancreatic cancer contraindicated due to high risk of morbidity/mortality
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or...
- Medical history and concurrent disease as below: -Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
See the full eligibility criteria
Who can join
- Histologically confirmed pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible. \ Note: histology must be confirmed prior to study treatment, however...
- Clinical stage T1-3, N0-2, M0 (per AJCC 8th ed)
- Resectable pancreatic cancer as defined by NCCN Guidelines 2.2021 and based on pancreatic protocol dual-phase CT imaging. Multi-detector computed tomography (MDCT) angiography, performed by acquiring thin, preferably...
- No arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA])
- No tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity
- Age \> 18 years
- Patients must agree to pre-treatment biopsy(which may have been collected on a universal consent), on-treatment biopsy, and definitive surgical resection
- ECOG performance status of 0 or 1
- No prior treatment for diagnosis of pancreatic cancer
- Normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. )
- Creatinine ≤1.5 × ULN OR Measured or calculated creatinine clearance (Creatinine clearance (CrCl) should be calculated per institutional standard., GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for...
- Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN; ALT (SGPT) =alanine aminotransferase (serum glutamic pyruvic...
- International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic...
- Ability to understand and sign a written informed consent document. Participant must have willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- A female participant is eligible to participate if she is not pregnant , not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 120 days plus 30 days (a menstruation cycle) after the last dose of study treatment.
- Males who are sexually active with WOCBP must agree to follow study instructions for method(s) of contraception for the duration of treatment with study treatment(s) and for a total of 180 days post treatment...
What rules you out
- Borderline resectable, locally advanced or distant metastatic disease
- Any medical condition which makes definitive surgical resection of the pancreatic cancer contraindicated due to high risk of morbidity/mortality
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine...
- Medical history and concurrent disease as below: -Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
- Evidence of uncontrolled, active infection, requiring parenteral or oral anti-bacterial, anti-viral or anti-fungal therapy ≤ 28 days prior to screening on study.
- Participants with a condition requiring chronic systemic oral treatment with either antibiotics or anti-fungals
- Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
- Participants with active, known, or suspected autoimmune disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. \ Note: for those participants who will be undergoing planned splenectomy, vaccinations against S. pneumoniae...
- Use of probiotics ≤ 28 days prior to screening on study.
- Known human immunodeficiency virus (HIV), known active Hepatitis A, or known Hepatitis B
- History of acute diverticulitis within the last 6 months or current chronic diarrhea
- Expected to require any other form of antineoplastic or surgical therapy while on study.
- Pre-existing peripheral neuropathy \> Grade 1, as defined by CTCAE v5.0.
- Pregnant or lactating women.
- A WOCBP who has a positive urine pregnancy test within 72 hours or no pregnancy test prior to registration.
- WOCBP who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and 120 days plus 30 days (a menstruation cycle) after the last dose of study treatment. WOCBP...
- Sexually active fertile men not using effective birth control if their partners are WOCBP.
- History of primary immunodeficiency.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- History of organ allograft or allogeneic bone marrow transplant.
- Any prior radiation therapy, immunotherapy, or biologic ('targeted') therapy for treatment of the patient's pancreatic tumor. Biliary stent is allowed.
- Treatment for other invasive carcinomas within the last two years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of...
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery.
- History of allergy to study treatments or any of its components.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.