Personalized Cancer Vaccine + PD-L1 Blocker for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen ByVinod Balachandran, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety or treating pancreatic cancer with surgery to remove cancerour tissue, followed by atezolizumab, followed by a personalized cancer vaccine (PCV), and then with chemotherapy.

Eligibility Criteria

Adults with resectable pancreatic cancer, specifically adenocarcinoma, who haven't had prior treatments like chemotherapy or immunotherapy. They must be in good physical condition (ECOG 0-1), able to follow the study plan, and agree to use effective contraception. Excluded are those with other cancers under treatment, serious organ/system conditions, certain infections or immune disorders, recent major heart issues, allergies requiring steroids pre-treatment.

Inclusion Criteria

Able to comply with the study protocol, in the investigator's judgment

I am 18 years old or older.

Tumors must be radiographically resectable, defined as: A clear fat plane around the celiac and superior mesenteric arteries, patent superior mesenteric and portal veins without primary tumor involvement, no encasement of the superior mesenteric vein or portal veins, no encasement of the superior mesenteric or hepatic arteries, no metastatic disease, no extra-regional nodal disease, subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation, pancreatic cancer surgical staging: T 1-3, N0-2, M0 per AJCC 8th edition staging, performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status, subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for PDAC, subjects must be able to read, understand, and sign informed consent, women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study initiation, for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab and for at least 90 days after the last dose of RO7198457, for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom during the entire study period and up to 90 days after last administration of RO7198457, examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization and established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices, hormonal contraceptive methods must be supplemented by a barrier method plus spermicide, the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient, periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception

+1 more

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply: prior neoadjuvant treatment or radiation therapy for PDAC, prior therapy with uPD-1 antibody or any other immune therapy, borderline resectable, locally unresectable or metastatic PDAC, pancreas tumor histology other than PDAC, pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment, life expectancy less than 12 weeks, inability to comply with study and/or follow-up procedures, any other malignancy for which the patient is undergoing active treatment which will be concurrent with the investigational agent in this study, patients with unresolved Clavien-Dindo >/= Grade 3 postoperative complications, active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, active tuberculosis, known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications, known hypersensitivity or allergy to the active substance or to any of the excipients of RO7198457, atezolizumab, oxaliplatin, leucovorin, irinotecan, or fluorouracil, serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, history of connective tissue disorders, history of interstitial lung disease, history of the following within 6 months prior to RO7198457 administration: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram (ECG) abnormality, history or autoimmune disease, patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible, patient with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible, patients type 2 diabetes mellitus may be eligible, patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only may be eligible provided that they meet specific conditions, treatment with systemic immunosuppressive medication within 2 weeks prior to RO7198457 administration, subjects with allergies to IV contrast agents requiring pretreatment with corticosteroids, history of idiopathic pulmonary fibrosis, pneumonitis, known primary immunodeficiencies, prior allogeneic bone marrow transplantation or prior solid organ transplantation, any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug, known clinically significant liver disease, previous splenectomy, administration of a live, attenuated vaccine within 4 weeks before RO7198457 administration or anticipation that such a live attenuated vaccine will be required during the study

Participant Groups

The trial is testing a sequence of treatments for pancreatic cancer: surgery to remove the tumor followed by atezolizumab (a PD-L1 blocker), then a personalized cancer vaccine (PCV) tailored to the patient's tumor specifics, and finally mFOLFIRINOX chemotherapy regimen.

1Treatment groups

Experimental Treatment

Group I: Pancreatic CancerExperimental Treatment3 Interventions

Radiologically resectable primary pancreatic tumors

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: