← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug related toxicity

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

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
2017
Completed Phase 3
~5860
mFOLFIRINOX
2013
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,781 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,660 Total Patients Enrolled
Vinod Balachandran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04161755 — Phase 1
Pancreatic Cancer Research Study Groups: Pancreatic Cancer
Pancreatic Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04161755 — Phase 1
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04161755 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other investigations employed Atezolizumab?

"In 2008, the first clinical trial of Atezolizumab was conducted by SCRI Tennessee Oncology Chattanooga. Since then, 80 such studies have been completed and 350 are currently active across many centres in Commack, New jersey."

Answered by AI

Has Atezolizumab been granted certification by the Food and Drug Administration?

"Due to the limited data available, our team at Power estimated Atezolizumab's safety and efficacy to fall on a scale of 1. This is due in part because this trial is only Phase 1."

Answered by AI

What medical conditions can Atezolizumab be helpful in alleviating?

"Atezolizumab is most commonly prescribed to treat small cell lung cancer. Beyond this, it has seen success in helping patients with malignant neoplasms and non-small cell lung carcinoma after surgery."

Answered by AI

In what locations can participants access this trial?

"Patients are eligible to join this trial at Memorial Sloan Kettering Cancer Center@ Commack (All Protocol Activities) in Commack, Memorial Sloan Kettering Nassau (All Protocol Activities) in Rockville Centre, and Memoral Sloan Kettering Monmouth (All Protocol Activities), along with 7 other locations."

Answered by AI

Is this trial pioneering a novel approach?

"According to the current data, 350 clinical trials featuring Atezolizumab are taking place in 74 distinct countries and 1646 cities. This drug has been studied since 2008 when Hoffmann-La Roche launched a Phase 2 study that included 720 patients; subsequently, 80 studies have been conducted."

Answered by AI

Is enrollment into this research project still available for participants?

"This medical trial is not currently enrolling patients. Initially posted on December 13th 2019 and recently edited on October 21st 2022, the study has been closed for recruitment at this time. If interested in other studies, there are 700 clinical trials actively recruiting participants with malignant neoplasm of pancreas and 350 Atezolizumab-related studies that need volunteers."

Answered by AI

How many individuals have signed up to participate in this clinical experiment?

"At present, this medical trial is not open for patient recruitment. First posted on December 13th 2019 and last updated October 21st 2022, no one can currently take part in the study. However, there are 700 trials actively recruiting participants with malignant neoplasm of pancreas and 350 studies seeking patients who may benefit from Atezolizumab treatment."

Answered by AI
~3 spots leftby Nov 2024