Chemotherapy + Immunotherapy Before Surgery for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byBrandon Smaglo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies the effects of gemcitabine, nab-paclitaxel, durvalumab, and oleclumab in treating patients with primary pancreatic cancer that may be able to be removed by surgery (resectable/borderline resectable). Chemotherapy drugs, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and oleclumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving gemcitabine, nab-paclitaxel, durvalumab, and oleclumab may help control the disease in patients with resectable/borderline resectable primary pancreatic cancer.

Eligibility Criteria

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.

Inclusion Criteria

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.

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Exclusion Criteria

I have had cancer spread to the lining of my brain and spinal cord.

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.

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Participant Groups

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.

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.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: