New cocktail of drugs takes on tough pancreatic cancer
NCT ID NCT07671339
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing whether adding an experimental cancer vaccine (ELI-002 7P) and an immunotherapy drug (tislelizumab) to standard chemotherapy (mFOLFIRINOX) is safe and effective for people with a specific type of pancreatic cancer that has a KRAS mutation. The study will enroll 20 patients whose cancer is still confined to the pancreas and can potentially be removed by surgery. The main goal is to check for serious side effects, while also seeing how well the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mFOLFIRINOX (chemotherapy), ELI-002 7P (cancer vaccine), and tislelizumab (immunotherapy)
- What this could lead to
- If successful, this could point toward a more effective treatment approach for pancreatic cancer that may improve surgical outcomes and long-term control.
- What could go wrong
- This is a very early Phase 1 trial with only 20 participants, focused primarily on safety. The combination may cause significant side effects and may not prove effective against the cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Documentation of Disease * Pathologically confirmed adenocarcinoma of the pancreas. * Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D. * Definition of Disease * Patients must have resectable or borderline resectable localized disease as defined by NCCN Guidelines v2.2025. Staging CT or MRI of the chest/abdomen/pelvis at enrollment must be negative for metastatic disease. * Prior Treatment * Up to 4 doses of neoadjuvant mFOLFIRINOX are allowed prior to enrollment. Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2), alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator). * Age ≥18 years. * ECOG Performance Status 0-1 * Pregnancy and Nursing * Not pregnant or breastfeeding. * Evidence of post-menopausal status or a negative urinary or serum pregnancy test for females of child-bearing potential within 28 days prior to initiation of treatment. * Required Organ Function * Hematologic function: * ANC ≥1,500/mm³ * Platelets ≥100,000/mm³ * Hemoglobin ≥8.0 g/dL * Renal function: * Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula or 24-hour urine collection). * Hepatic function: * Total bilirubin ≤1.5 × ULN (Gilbert's syndrome allowed up to ≤3 × ULN) * AST and ALT ≤3 × ULN Albumin: ≥2.5 g/dL * Cardiac function: Patients with known cardiac disease or prior exposure to cardiotoxic agents should undergo risk assessment per NYHA classification; patients must be class or better. Compliance and Life Expectancy * Patient is willing and able to comply with protocol procedures, treatment, and follow-up. * Estimated life expectancy of at least 12 weeks per treating physician. * Comorbid Conditions * No active infection requiring parenteral antibiot ic(s) * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Allergies: No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients). * Concomitant Medications * Concomitant medication use should only exclude patients when clinically relevant drug-drug interactions or overlapping toxicities are expected to impact safety or efficacy. All concomitant medications from 7 days prior to screening through 12 weeks after the last dose of investigational product must be documented in the medical record. * Contraception Requirements * Patients of reproductive potential must use highly effective contraception from screening through 90 days after the last dose of immunotherapy. Exclusion Criteria: * Locally advanced unresectable PDAC (per NCCN v2.2025), including unreconstructable venous anatomy, arterial tumor contact ≥180° (superior mesenteric, celiac, or hepatic artery), or aortic invasion * Metastatic PDAC. * Prior treatment with TNF receptor agonists (OX40, CD27, CD137/4-1BB, GITR) or prior checkpoint inhibitor therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1). * Active infection including tuberculosis, hepatitis A, active HBV (HBsAg+), or active HCV. Patients with resolved HBV (anti-HBc+, HBsAg-) may enroll. HCV Ab+ patients are eligible if HCV RNA PCR is negative. Successfully treated cholangitis is not exclusionary if no active infection remains. * Known HIV infection not meeting the on-study guideline criteria above. * Active or prior documented autoimmune/inflammatory disorders including: IBD, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, systemic sclerosis, CNS or motor neuropathy of autoimmune origin (e.g., Guillain-Barré, myasthenia gravis, multiple sclerosis). Exceptions: vitiligo, alopecia, stable hypothyroidism on replacement, remote (\>5 years) inactive autoimmune disease, or celiac disease controlled by diet. * Uncontrolled intercurrent illness including, but not limited to, symptomatic CHF, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, interstitial lung disease, serious GI conditions with chronic diarrhea, or psychiatric/social situations limiting compliance. * Current or prior systemic immunosuppressive medication within 14 days of first ELI-002 7P dose. * Exceptions: intranasal/inhaled/topical steroids, local steroid injections, physiologic replacement doses (≤10 mg prednisone/day or equivalent), steroids as premedication for imaging contrast allergy, or limited steroid use as anti-emetic with mFOLFIRINOX. * Receipt of a live attenuated vaccine within 30 days prior to first dose of immunotherapy. * Pregnancy, breastfeeding, or unwillingness to use effective contraception during treatment and for 90 days after last immunotherapy dose. * Allergy or hypersensitivity to study drugs or excipients. * Any other malignancy within 3 years except adequately treated cervical carcinoma in situ, non-muscle-invasive bladder cancer, localized prostate cancer, or non-melanoma skin cancers. * Prior allogeneic organ transplantation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activites)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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