Study on Penpulimab for First-line Treatment of Recurrent or Metastatic Nasopharyngeal Cancer

Sponsor: Akeso

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04974398

Provider View

This clinical trial is testing the effectiveness and safety of the drug penpulimab, combined with chemotherapy, compared to a placebo with chemotherapy, for treating nasopharyngeal cancer that has returned or spread.

Patient Parameters

Program Overview

This study aims to find out if penpulimab, when used with chemotherapy, is more effective and safe compared to a placebo with chemotherapy for patients with nasopharyngeal cancer that has come back or spread to other parts of the body. The trial involves multiple centers and is conducted in a randomized, double-blind manner, meaning neither the participants nor the researchers know who is receiving the actual drug or the placebo.

Eligibility Criteria

Inclusion Criteria

  • Must voluntarily sign a consent form.
  • Main study: Age between 18 and 75 years.
  • Substudy: Age between 12 and 18 years, weighing at least 35 kg.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Expected to live for at least 3 more months.
  • Must have confirmed nasopharyngeal cancer.
  • Cancer must be at an advanced stage (stage IVB) and not suitable for local or radical treatment, or must have returned or spread more than 6 months after previous treatment.
  • Must not have received systemic treatment for recurrent or metastatic cancer.
  • Must have at least one tumor that can be measured.
  • Must have adequate organ function.
  • Must agree to use effective birth control during and for 150 days after the study.

Exclusion Criteria

  • Have nasopharyngeal adenocarcinoma or sarcoma.
  • Have had another cancer within the last 3 years, except for certain cured cancers.
  • Have participated in another drug or device study within 4 weeks before this study.
  • Have received previous immunotherapy.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of inflammatory bowel disease.
  • Have a history of immunodeficiency or test positive for HIV.
  • Have active tuberculosis or syphilis.
  • Have had organ or stem cell transplants.
  • Have active Hepatitis B or C.
  • Have untreated cancer spread to the brain or spinal cord.
  • Have peripheral nerve damage.
  • Have unresolved side effects from previous cancer treatments.
  • Have received a live vaccine within 30 days before the study.
  • Have allergies to study drugs or serious reactions to monoclonal antibodies.
  • Are pregnant or breastfeeding.

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