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PD-L1 Inhibitor
Personalized Cancer Vaccine + PD-L1 Blocker for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Vinod Balachandran, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be >/= 18 years of age at time of informed consent
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination of treatments for pancreatic cancer. The hope is that it will be more effective and have fewer side effects than current treatments.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include typical reactions from immunotherapies such as fatigue, allergic reactions to infusions and vaccines; gastrointestinal symptoms from chemo; increased risk of infections; possible inflammation related to atezolizumab; and tissue-specific side effects due to individual health variability.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Drug related toxicity
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pancreatic CancerExperimental Treatment3 Interventions
Radiologically resectable primary pancreatic tumors
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
mFOLFIRINOX
2013
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,049 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,971 Total Patients Enrolled
Vinod Balachandran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My pancreatic tumor can be removed surgically and looks like adenocarcinoma on scans.
Research Study Groups:
This trial has the following groups:- Group 1: 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.