Study on Combining Immunotherapy with Standard Chemotherapy for Advanced Pancreatic Cancer

Sponsor: ImmunityBio, Inc.

Sponsor score: 60

ClinicalTrials ID:NCT04390399

This clinical trial is testing whether adding new immunotherapy drugs to standard chemotherapy can improve treatment outcomes for patients with locally advanced or metastatic pancreatic cancer. The study will compare the effectiveness and safety of the combination treatment against standard chemotherapy alone.

Patient Parameters

Program Overview

This study aims to evaluate if combining immunotherapy drugs with standard chemotherapy can better treat pancreatic cancer that is either locally advanced or has spread to other parts of the body. The trial includes three groups: two groups will receive either the combination treatment or standard chemotherapy, and one group will receive only the combination treatment. Each group will be assessed separately based on their treatment history and cancer stage.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Have confirmed pancreatic cancer that cannot be surgically removed or has spread.
  • For Group A: Must have been treated with gemcitabine and nab-paclitaxel for at least 16 weeks and shown stable disease or improvement.
  • For Group B: Must have disease progression after initial treatment with specific chemotherapy regimens.
  • For Group C: Must have disease progression after at least two lines of therapy.
  • Must have a performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have at least one measurable tumor.
  • Must be able to attend study visits and follow-up.
  • Must agree to use effective contraception during and after the study.

Exclusion Criteria

  • Weigh less than 40 kg.
  • Have serious uncontrolled diseases that could complicate treatment.
  • Have autoimmune diseases like lupus or rheumatoid arthritis.
  • For Group A: Have tumors with specific genetic mutations (BRCA1/2).
  • For Group B: Have previously received certain treatments for pancreatic cancer.
  • Have had an organ transplant requiring immunosuppression.
  • Have inflammatory bowel disease.
  • Have poor organ function based on specific lab tests.
  • Have uncontrolled high blood pressure or significant heart problems.
  • Have breathing difficulties requiring oxygen therapy.
  • Are on long-term steroid treatment.
  • Have allergies to study medications.
  • Are taking certain medications that affect drug metabolism.
  • Are participating in another clinical trial.
  • Are pregnant or breastfeeding.
  • Have had another cancer in the past 5 years that is active or requires treatment.

Locations

FACILITYZIPCITYSTATE
Chan Soon-Shiong Institute for Medicine90245El SegundoCalifornia
Hoag memorial Presbyterian Hospital92663Newport BeachCalifornia
Astera Cancer Care08816East BrunswickNew Jersey
Avera Cancer Institute57105Sioux FallsSouth Dakota

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