Study on Toripalimab with Chemotherapy for Recurrent Metastatic Nasopharyngeal Cancer

Sponsor: Coherus Biosciences, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT06457503

This clinical trial is testing a new treatment combining the drug toripalimab with chemotherapy drugs cisplatin and gemcitabine to see if it can help treat nasopharyngeal cancer that has returned or spread.

Patient Parameters

Program Overview

The main goal of this study is to find out how effective the combination of toripalimab and chemotherapy (cisplatin and gemcitabine) is in treating nasopharyngeal cancer that has come back or spread to other parts of the body. The study will measure how well the treatment works by looking at how much the cancer shrinks in participants, as evaluated by a special review committee.

Description

This study is focused on evaluating the effectiveness of a new treatment for nasopharyngeal cancer that has returned or spread. The treatment combines toripalimab, an immunotherapy drug, with chemotherapy drugs cisplatin and gemcitabine. Researchers will assess how well this combination works by measuring the reduction in cancer size in participants. The study includes participants with both Epstein-Barr virus (EBV) associated and non-EBV associated nasopharyngeal cancer. The effectiveness will be measured using specific criteria to determine the response rate of the cancer to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of recurrent or metastatic nasopharyngeal cancer, which may be associated with the Epstein-Barr virus (EBV) or not.
  • The cancer must be at an advanced stage (stage IV-B) or have returned after previous treatment.
  • There must be a measurable tumor that can be tracked during the study.
  • For those with recurrent cancer, at least 6 months must have passed since the last treatment before the cancer returned.

Exclusion Criteria

  • Cancer that can be treated with local therapy aimed at curing it.
  • Have received prior systemic therapy for recurrent or metastatic cancer.
  • Cancer that has returned within 6 months of previous treatment with chemoradiation.
  • Rapidly worsening cancer symptoms, such as bleeding or severe pain, as judged by the doctor.
  • Active or untreated cancer spread to the brain or spinal cord, unless previously treated and stable for at least 1 month without steroid medication.

Locations

FACILITYZIPCITYSTATE
University of California, Irvine92697IrvineCalifornia
University of California, San Francisco94115San FranciscoCalifornia
Boston Medical Center02118BostonMassachusetts

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