Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I've been treated with FOLFIRINOX for 3-6 months and my cancer hasn't worsened.
Select...
I had my standard chemotherapy less than 6 weeks ago and am ready to start the study treatment.
Select...
I am 18 years old or older.
Select...
My body weight is over 30kg.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My kidney function, measured by creatinine or its clearance, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with dose limiting toxicities in the first 10 weeks of treatment
Progression Free Survival
Progression Free Survival (Phase II)
+1 moreSecondary outcome measures
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 moreTrial 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
499 Previous Clinical Trials
164,839 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,604 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,884 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that could interfere with the study.I may have significant nerve pain or damage, subject to my doctor's approval.I have been diagnosed with a type of pancreatic cancer that is locally advanced or borderline resectable.I've been treated with FOLFIRINOX for 3-6 months and my cancer hasn't worsened.I had my standard chemotherapy less than 6 weeks ago and am ready to start the study treatment.I am 18 years old or older.My body weight is over 30kg.I agree to use effective birth control or abstain from sex during the study and for 90 days after.I am willing and able to follow the study's requirements.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.I have previously been treated with a PD1 or PD-L1 inhibitor.I haven't had major surgery within the last 30 days, but minor procedures like a laparoscopy are okay.My cancer has visibly spread into my duodenum.I have not had serious autoimmune or inflammatory disorders in the last 3 years, except for allowed conditions like vitiligo, alopecia, stable hypothyroidism, or psoriasis not needing systemic treatment.I have not received a live vaccine within the last 30 days.I do not have active infections like TB, hepatitis B or C, or HIV.I have active hepatitis B or had it in the past but it's now resolved.I have hepatitis C antibodies but no active virus.My pancreatic cancer has spread to the lining of my stomach or bowel.I have had cancer before, but it was a different type than my current diagnosis.I have active Hepatitis B or C.I can take care of myself and am up and about more than half of my waking hours.My organ and bone marrow functions are normal.I am currently undergoing or have had cancer treatment other than chemotherapy.My kidney function, measured by creatinine or its clearance, is within the required range.I don't have major side effects from past cancer treatments, except for hair loss or skin changes.I haven't taken immunosuppressive drugs in the last 28 days, except as part of chemotherapy.My cancer has spread to other parts of my body.I had skin cancer (not melanoma) treated and currently show no signs of it.I have had an organ transplant and take drugs to suppress my immune system.I am getting radiation treatment from a place not running this study.My treatment plan is based on modified FOLFIRINOX doses.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + SABR
Awards:
This trial has 2 awards, including:- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has this investigation been implemented in healthcare centers?
"Eight medical centres are currently enrolling patients in this trial. These include Memorial Sloan Kettering Cancer Center (All Protocol Activities) located in New york, Cedars-Sinai Medical Center based in Los Angeles, and Memoral Sloan Kettering Westchester (All Protocol Activities) situated Harrison; as well as other sites scattered around the United States of America."
Answered by AI
What objectives is this experiment striving to accomplish?
"AstraZeneca, the trial sponsor, has reported that Progression Free Survival (Phase II) over one year will be the main objective. Additionally, measurable secondary outcomes such as changes in protein levels from baseline and inflammatory cytokines measured by serum analysis are also being assessed. Furthermore, an evaluation of how microbiome alterations correlate with treatment is underway via stool sample examination."
Answered by AI
What is the current capacity for recruitment into this investigation?
"Unfortunately, this clinical trial has already concluded its participant recruitment period. First posted on August 14th 2020 and last updated on August 11th 2022; anyone seeking to join a similar medical study should instead look at the 787 studies actively enrolling patients with adenocarcinoma or the 333 trials for Durvalumab admitting participants."
Answered by AI
Has Durvalumab been previously investigated in any other research projects?
"Durvalumab was initially studied at City of Hope in 2010, resulting in 106 completed clinical trials. Currently, 333 more are taking place across the United States with many located in New york City."
Answered by AI
In what contexts is Durvalumab typically prescribed?
"Durvalumab is a popular treatment for unresectable stage III non-small cell lung cancer, and it has also been used to effectively address metastatic urothelial carcinoma and advanced directives."
Answered by AI
Is there still an opportunity for participants to join this research endeavor?
"Based on the clinicaltrials.gov database, this medical study is not currently seeking new candidates - its last update was 8/11/2022. However, there are 1120 other trials that have open enrolment at present."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger