Study on Gemcitabine, Cisplatin, and Durvalumab Alternating with Pemigatinib for Treating Advanced Biliary Tract Cancers with FGFR2 Changes

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07780838

Provider View

This clinical trial is exploring a new treatment approach for advanced biliary tract cancers that cannot be surgically removed and have specific FGFR2 genetic changes. The study tests a combination of chemotherapy, immunotherapy, and a targeted therapy drug to see if it can effectively control the cancer.

Patient Parameters

Program Overview

This phase II study is testing a treatment plan for biliary tract cancer that cannot be removed by surgery and has spread locally or to other parts of the body. The treatment involves alternating cycles of chemotherapy drugs (gemcitabine and cisplatin) and an immunotherapy drug (durvalumab) with a targeted therapy drug (pemigatinib). The goal is to see if this combination can effectively treat cancers with FGFR2 genetic changes by stopping cancer cells from growing and spreading.

Description

The main goal of this study is to see how well a treatment plan that alternates between chemotherapy, immunotherapy, and a targeted therapy drug works for patients with advanced biliary tract cancer that has specific FGFR2 genetic changes. Researchers want to know if this approach can shrink tumors and improve patient outcomes.

The study involves two types of treatment cycles:

  1. Chemoimmunotherapy Cycle (CIO Block): Patients receive chemotherapy drugs (cisplatin and gemcitabine) and an immunotherapy drug (durvalumab) through an IV. This cycle repeats every 28 days for two cycles.

  2. FGFR Inhibitor Cycle (FGFRi Block): Patients take the targeted therapy drug (pemigatinib) orally for 14 days. This cycle repeats every 21 days for three cycles.

Patients will switch between these cycles based on how their cancer responds. If the cancer does not progress after the FGFRi cycle, patients will switch back to the CIO cycle. If the cancer progresses after both cycles, patients may stop the study treatment.

Throughout the study, patients will have regular scans and blood tests to monitor their cancer and overall health. After completing the study treatment, patients will have follow-up visits to check their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with advanced biliary tract cancer that cannot be surgically removed.
  • Cancer must have specific FGFR2 genetic changes, confirmed by a certified lab test.
  • Patients may have received one cycle of similar chemotherapy before joining the study.
  • Must have at least one measurable tumor.
  • Good overall health with a performance status score of 0 or 1.
  • Life expectancy of more than 4 months.
  • Ability to understand and agree to the study requirements.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • HIV-positive patients may participate if their condition is stable and controlled.
  • Patients with controlled hepatitis B or cured hepatitis C are eligible.

Exclusion Criteria

  • Recent treatment with certain cancer therapies or investigational drugs.
  • Unresolved side effects from previous cancer treatments.
  • Previous treatment with FGFR-targeted therapy.
  • Abnormal calcium or phosphate levels that cannot be controlled.
  • Significant gastrointestinal issues affecting drug absorption.
  • Eye conditions that may increase risk of eye toxicity.
  • Use of certain medications that affect drug metabolism.
  • Active autoimmune or inflammatory disorders requiring treatment.
  • Recent use of immunosuppressive medications.
  • Recent live vaccine administration.
  • History of organ transplantation.
  • Active hepatitis B, C, or uncontrolled HIV infection.
  • Allergy to study treatments.
  • Recent major surgery.
  • Brain metastases or unresolved spinal cord compression.
  • Uncontrolled illnesses or psychiatric conditions affecting study participation.
  • History of significant heart disease or recent heart attack.
  • Pregnant or breastfeeding women, or those unwilling to use contraception.
  • History of another primary cancer unless treated and not expected to recur.
  • Any other medical condition that may interfere with study participation.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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