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Monoclonal Antibodies
Chemotherapy + Immunotherapy Before Surgery for Pancreatic Cancer
Phase 2
Recruiting
Led By Brandon G Smaglo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has histologically or cytologically confirmed resectable or borderline resectable pancreatic adenocarcinoma per MD Anderson criteria
Must not have
Has a history of leptomeningeal carcinomatosis
Has a prior history of myocardial infarction, transient ischemic attack, or stroke within the past 3 months prior to the scheduled first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
This trial is studying gemcitabine, nab-paclitaxel, durvalumab, and oleclumab to see how well they work in treating patients with resectable/borderline resectable primary pancreatic cancer.
Who is the study for?
This trial is for adults over 18 with resectable or borderline resectable pancreatic adenocarcinoma who haven't had cancer treatment before. They must be able to follow the study plan, have good organ function, and a life expectancy of at least 6 months. Pregnant or breastfeeding individuals can't join, nor those with certain health conditions like autoimmune diseases, recent major surgery, or active infections.Check my eligibility
What is being tested?
The trial tests if combining chemotherapy drugs (gemcitabine and nab-paclitaxel) with immunotherapy antibodies (durvalumab and oleclumab) before surgery can help treat pancreatic cancer. It's a phase II study to see how these treatments affect tumor growth by killing cells or boosting the immune system.See study design
What are the potential side effects?
Possible side effects include reactions from the immune system affecting organs, infusion-related reactions from antibody treatments, blood cell count changes leading to increased infection risk or bleeding problems, liver enzyme alterations indicating potential liver damage, fatigue and digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My pancreatic cancer is confirmed and considered operable.
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My body weight is over 35 kg.
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My kidney function, measured by creatinine clearance, is above 40 mL/min.
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I am post-menopausal or not pregnant if pre-menopausal.
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I have not received any cancer treatment for pancreatic cancer.
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I am willing to have a special camera test to look inside my stomach.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer spread to the lining of my brain and spinal cord.
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I had a heart attack, mini-stroke, or stroke in the last 3 months.
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I am not pregnant, breastfeeding, and if capable of having children, I agree to use birth control.
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I have had a blood clot in the last 3 months.
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I had major surgery less than 4 weeks before starting the treatment.
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I am currently not on any cancer treatments like chemotherapy or hormonal therapy.
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I have not had a live vaccine in the last 30 days.
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I have a serious illness that is not under control.
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I have had another type of cancer before.
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I do not have an active infection like TB, hepatitis B, or C.
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I have used immunosuppressive medication within the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Major pathological response rate (=< 5% viable tumor cells)
Other outcome measures
Change in circulating tumor deoxyribonucleic acid (ctDNA) levels
Frequency of intraoperative and postoperative complications
Overall survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (durvalumab, oleclumab, nab-paclitaxel, gemcitabine)Experimental Treatment4 Interventions
Patients receive durvalumab IV over 1 hour on day 1, oleclumab IV over 1 hour, nab-paclitaxel IV, and gemcitabine IV over 1 hour over 30-40 minutes on days 1 and 15. Treatment repeats every 28 days for 2-6 cycles. Within 4-8 weeks after completion of last cycle of treatment, patients undergo surgical resection. After surgical resection, patient may receive adjuvant therapy with durvalumab and oleclumab, durvalumab, oleclumab, gemcitabine, and nab-paclitaxel, other chemotherapy, or observation only at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3840
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Oleclumab
2015
Completed Phase 2
~880
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,249 Total Patients Enrolled
Brandon G SmagloPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer spread to the lining of my brain and spinal cord.Your hemoglobin level is at least 9.0 grams per deciliter.I am fully active or restricted in physically strenuous activity but can do light work.My pancreatic cancer is confirmed and considered operable.My bilirubin levels are within normal range, except if I have Gilbert's syndrome.My body weight is over 35 kg.I had a heart attack, mini-stroke, or stroke in the last 3 months.I am not pregnant, breastfeeding, and if capable of having children, I agree to use birth control.I have had a blood clot in the last 3 months.My kidney function, measured by creatinine clearance, is above 40 mL/min.You have been diagnosed with cancer that has spread to other parts of your body based on imaging tests.You have enough infection-fighting white blood cells in your body.I am post-menopausal or not pregnant if pre-menopausal.You have received an organ from someone else in the past.Your platelet count is at least 100,000 per cubic millimeter.I have not received any cancer treatment for pancreatic cancer.I had major surgery less than 4 weeks before starting the treatment.I am currently not on any cancer treatments like chemotherapy or hormonal therapy.I might require radiation therapy before surgery.I have not had a live vaccine in the last 30 days.I have a serious illness that is not under control.I am willing and able to follow the study's treatment plan and attend all visits.I am willing to have a special camera test to look inside my stomach.You have a current or past autoimmune or inflammatory disorder.I am 18 years old or older.I have had another type of cancer before.You have a history of ongoing problems with your immune system.You are expected to live for at least 6 more months.Your AST and ALT levels in your blood should not be more than 2.5 times the normal limit at the study site.You have high levels of calcium or phosphorus in your blood.I do not have an active infection like TB, hepatitis B, or C.You have participated in a clinical trial before and received treatment with durvalumab or oleclumab, no matter which group you were in.I have used immunosuppressive medication within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (durvalumab, oleclumab, nab-paclitaxel, gemcitabine)
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.
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