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

Study 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 below
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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 bilirubin levels are within normal range, except if I have Gilbert's syndrome.
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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 and able to follow the study's treatment plan and attend all visits.
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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.

Timeline

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

Trial 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
~3870
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
2,967 Previous Clinical Trials
1,804,772 Total Patients Enrolled
Brandon G SmagloPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04940286 — Phase 2
Pancreatic Cancer Research Study Groups: Treatment (durvalumab, oleclumab, nab-paclitaxel, gemcitabine)
Pancreatic Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04940286 — Phase 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04940286 — Phase 2

Frequently Asked Questions

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

What are the primary indications for Nab-paclitaxel?

"Nab-paclitaxel can be used to treat aggressive forms of lung and bladder cancer that have metastasized."

Answered by AI

How many volunteers will be included in this research project?

"That is accurate. The most recent information available on clinicaltrials.gov suggests that this study is still actively recruiting patients. This specific trial was first posted on September 28th, 2021 and last updated on October 12th, 2022. So far, 30 individuals have been enrolled at a single location."

Answered by AI

Are there currently any open slots for patients to enroll in this trial?

"The clinical trial is still recruiting patients, as indicated by the most recent update on October 12th, 2022. The study was first posted September 28th, 2021."

Answered by AI

What is the maximum dosage of Nab-paclitaxel that a person can take without experiencing any adverse effects?

"Nab-paclitaxel has received a score of 2 from our Power team. This is due to the fact that, while there are Phase 2 trials supporting its safety, none have been done to test for efficacy."

Answered by AI

Can you tell me if there is a history of using Nab-paclitaxel in medical research?

"Nab-paclitaxel is being trialled in 1472 different ongoing investigations, with 368 of them being Phase 3 trials. Nab-paclitaxel's clinical trials are located all around the world, with 68376 sites running active trials."

Answered by AI
~11 spots leftby Oct 2025