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PD-L1 Inhibitor

Durvalumab + Radiation Therapy for Pancreatic Cancer

Phase 1 & 2
Waitlist Available
Led By Eileen O'Reilly, 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
Patients must have normal organ and marrow function as defined below: Absolute Neutrophil Count (ANC) ≥1.0 K/mcL, Platelets ≥75 K/mcL, Hemoglobin ≥ 9 g/dL, Total bilirubin ≤ 1.5 X upper limit of normal (ULN), AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN, Creatinine OR creatinine clearance ≤ 1.5 times the upper limit of normal OR > 40 mL/min for patients with creatinine levels above normal.
Patients must have received FOLFIRINOX for 3-6 months prior to enrollment with at least stable disease by restaging imaging.
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
°Malignancy treated with curative intent with no known active disease for 2 years before the first dose of study drug and low potential risk for recurrence.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for pancreatic cancer.

Who is the study for?
Adults over 18 with pancreatic cancer that's locally advanced or borderline resectable, who've had FOLFIRINOX chemotherapy for 3-6 months without disease progression. They must have good organ function and not be pregnant or breastfeeding. Men and women must agree to contraception, and no recent other cancers or treatments outside the protocol are allowed.
What is being tested?
The trial is testing if durvalumab combined with SABR (a type of targeted radiation therapy) is effective in treating pancreatic cancer. Durvalumab is an immunotherapy drug designed to help the immune system attack cancer cells.
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, fatigue, skin reactions, hormonal changes, flu-like symptoms, and potential infusion-related reactions. The radiation could cause localized pain or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've been treated with FOLFIRINOX for 3-6 months and my cancer hasn't worsened.
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I had my standard chemotherapy less than 6 weeks ago and am ready to start the study treatment.
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I am 18 years old or older.
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My body weight is over 30kg.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidney function, measured by creatinine or its clearance, is within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that could interfere with the study.
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My cancer was treated with the goal of cure, and I've been free of active disease for 2 years with a low risk of it coming back.
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I have previously been treated with a PD1 or PD-L1 inhibitor.
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I haven't had major surgery within the last 30 days, but minor procedures like a laparoscopy are okay.
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My cancer has visibly spread into my duodenum.
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I do not have active infections like TB, hepatitis B or C, or HIV.
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I have hepatitis C antibodies but no active virus.
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My pancreatic cancer has spread to the lining of my stomach or bowel.
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I have had cancer before, but it was a different type than my current diagnosis.
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I have active Hepatitis B or C.
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I am currently undergoing or have had cancer treatment other than chemotherapy.
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I haven't taken immunosuppressive drugs in the last 28 days, except as part of chemotherapy.
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My cancer has spread to other parts of my body.
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I had skin cancer (not melanoma) treated and currently show no signs of it.
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I have had an organ transplant and take drugs to suppress my immune system.
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I am getting radiation treatment from a place not running this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Progression Free Survival (Phase II)
Proportion of participants who have resectable disease
Secondary study objectives
Mean change in levels of immune cells from baseline
Mean change in levels of inflammatory cytokines from baseline
Mean change in microbiome from baseline
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Durvalumab + SABRExperimental Treatment2 Interventions
Durvalumab + Stereotactic Ablative Body Radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER
512 Previous Clinical Trials
163,346 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,394 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,638 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03245541 — Phase 1 & 2
Pancreatic Adenocarcinoma Research Study Groups: Durvalumab + SABR
Pancreatic Adenocarcinoma Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03245541 — Phase 1 & 2
Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03245541 — Phase 1 & 2
~3 spots leftby Sep 2025
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