Study on Combining Radiation Therapy with Durvalumab for Pancreatic Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT03245541

This clinical trial is exploring whether adding the drug durvalumab to standard radiation therapy can effectively treat people with locally advanced or borderline resectable pancreatic cancer. The study will also assess the safety and potential side effects of this combination treatment.

Patient Parameters

Program Overview

The aim of this study is to determine if combining the immunotherapy drug durvalumab with standard radiation therapy, known as stereotactic ablative radiotherapy (SABR), can be an effective treatment for patients with pancreatic cancer that is either locally advanced or borderline resectable. Researchers will also evaluate the safety of this treatment combination and monitor any side effects experienced by participants.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic cancer that is locally advanced or borderline resectable, as confirmed by medical tests.
  • Previously treated with FOLFIRINOX chemotherapy for 3-6 months, with stable disease shown in follow-up imaging.
  • A break of no more than 6 weeks between finishing chemotherapy and starting the study treatment.
  • Aged 18 years or older.
  • Weigh more than 30 kg (about 66 pounds).
  • In good general health with an ECOG performance status of 0 to 2.
  • Normal organ and bone marrow function, as shown by specific blood test results.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Men must agree to use effective contraception if sexually active with a woman of childbearing potential.
  • Able to understand and willing to sign a consent form.
  • Willing to follow the study protocol, including treatment and follow-up visits.

Exclusion Criteria

  • History of another cancer, unless treated successfully and inactive for at least 2 years.
  • Previously received other anti-cancer treatments not specified in the study.
  • Women who are breastfeeding.
  • Significant unresolved side effects from previous cancer treatments, except for hair loss or skin changes.
  • Currently receiving other investigational treatments for cancer.
  • Previous treatment with PD1 or PD-L1 inhibitors, including durvalumab.
  • Known spread of cancer to other parts of the body.
  • Recent major surgery within 30 days before starting the study treatment.
  • Allergic reactions to similar drugs as durvalumab.
  • Uncontrolled illnesses, such as infections or heart problems, that could interfere with the study.
  • Receiving radiation treatment outside of the study centers.
  • Active autoimmune or inflammatory disorders, except for certain stable conditions.
  • Use of immunosuppressive medications within 28 days before starting the study, except for chemotherapy.
  • History of organ transplant requiring immunosuppressive drugs.
  • Active infections, including hepatitis B, hepatitis C, or HIV.
  • Recent live vaccinations within 30 days before starting durvalumab.
  • Any condition that could interfere with the study or affect patient safety.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)11553UniondaleNew York

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