Study on Triple Immunotherapy for Advanced or Metastatic Merkel Cell Carcinoma Resistant to PD-(L)1 Treatment

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06056895

Provider View

This clinical trial is exploring a new combination of three immunotherapy drugs to treat Merkel cell carcinoma that has spread and is not responding to previous PD-(L)1 treatments. The study aims to see if this combination can help the immune system fight the cancer more effectively.

Patient Parameters

Program Overview

This phase II study is testing how well a combination of three immunotherapy drugs works for patients with advanced or metastatic Merkel cell carcinoma (MCC) that has spread to lymph nodes or other parts of the body and cannot be treated with surgery. The cancer must have continued to grow despite previous PD-(L)1 therapy. The three drugs used in this study are retifanlimab (anti-PD-1), tuparstobart (anti-LAG-3), and verzistobart (anti-TIM-3). These drugs are given through an IV to help reactivate the body's immune system to attack the cancer. The goal is to see if this combination can stop tumor growth when previous treatments have failed.

Description

In this study, all patients will receive the same combination of investigational drugs.

Screening Phase:

  • Patients will undergo a medical history review, physical exam, and various tests to ensure they are eligible for the study. This includes CT or MRI scans and signing an informed consent form.

Induction Phase:

  • Patients will receive two of the drugs (anti-LAG-3 and anti-TIM-3) every two weeks and retifanlimab (anti-PD-1) every four weeks through an IV. This phase includes regular clinical visits, physical exams, and safety tests. Treatment continues for up to 169 days unless the disease progresses or side effects become unacceptable. CT/MRI scans will be done every 8 weeks. Tumor biopsies and blood samples will be collected at specific times unless it is unsafe.

Maintenance Phase:

  • Patients will receive all three drugs every six weeks through an IV, along with regular clinical visits and safety tests. This phase continues for up to 715 days unless the disease progresses or side effects become unacceptable. CT/MRI scans will be done every 12 weeks. Blood samples will continue to be collected periodically.

If the cancer progresses, treatment will stop, and additional biopsies and blood samples may be taken if safe.

After completing the study treatment, safety visits will occur at 30 and 90 days, with long-term follow-up every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic Merkel cell carcinoma that cannot be cured with standard treatments.
  • Have at least one measurable tumor.
  • Be 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have previously received at least one treatment with an anti-PD-(L)1 drug.
  • Meet specific criteria for cancer progression after anti-PD-(L)1 treatment.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Be willing to undergo tumor biopsies during the study.
  • Be able to understand and sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test.
  • Agree to use effective contraception during the study and for 180 days after the last treatment.

Exclusion Criteria

  • Have unresolved side effects from previous treatments that could interfere with the study.
  • Have active cancer spread to the brain or a history of certain brain conditions.
  • Have had serious immune-related side effects from previous treatments.
  • Have allergies to any of the study drugs.
  • Have had another cancer within the last three years, with some exceptions.
  • Have active hepatitis B or C, or uncontrolled HIV infection.
  • Have an active autoimmune disease or require systemic immunosuppression.
  • Have a history of serious infections or lung disease.
  • Have significant heart disease or other serious medical conditions.
  • Have received a live vaccine within 30 days before starting the study.
  • Be pregnant or breastfeeding.

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