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Closed (no longer recruiting)Last updated: 3 May 2024

AK105-304: This study is evaluating the safety and effectiveness of chemotherapy plus targeted therapy, compared to chemotherapy plus placebo, in people with recurrent or metastatic nasopharyngeal cancer.A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Clinical summary

Summary

This study is recruiting participants with metastatic or recurrent nasopharyngeal carcinoma who have not received treatment for their recurrent or metastatic disease.

Eligible participants will be randomly allocated to one of two study groups. 

In Group A (Experimental), participants will receive targeted therapy (called penpulimab) plus chemotherapy (consisting of cisplatin and gemcitabine), which will then be followed by penpulimab monotherapy as maintenance treatment.

In Group B (Control), participants will receive a placebo plus chemotherapy (consisting of cisplatin and gemcitabine), which will then be followed by placebo monotherapy as maintenance treatment. Participants in Group B will have the opportunity to crossover to open-label treatment with penpulimab monotherapy after radiographic disease progression.

Conditions

This trial is treating patients with recurrent or metastatic nasopharyngeal cancer

Cancer

Head and Neck Cancers Head and Neck

Age

People12 - 75

Phase

III

Trial Acronym

AK105-304

More information

Trial Identifiers

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Trial sponsor

Akeso

Scientific Title

A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Eligibility

Inclusion

  • Voluntarily signed written Informed Consent Form(ICF).
  • Main study: Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
  • Substudy: Age of ≥ 12 years and < 18 years. Weight≥ 35KG.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival of ≥ 3 months.
  • Histologically or cytologically confirmed nasopharyngeal carcinoma.
  • Subjects with primary metastatic (nasopharyngeal carcinoma, stage IVB defined by the Union for International Cancer Control and the American Joint Committee on Cancer Staging System edition 8) nasopharyngeal carcinoma who are not suitable for local treatment or radical treatment; or nasopharyngeal carcinoma subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the end of previous radical treatment (radiotherapy with induction, concurrent, adjuvant chemotherapy);No systemic treatment has been received for recurrent or metastatic nasopharyngeal carcinoma, and local regional recurrence is not suitable for local treatment or has received local treatment.
  • At least one measurable lesion according to RECIST v1.1;
  • Has adequate organ function.
  • All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 150 days after the last dose of study treatment.

Exclusion

  • Subjects with pathologically diagnosed nasopharyngeal adenocarcinoma or sarcoma.
  • Subjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
  • Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
  • Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
  • Active autoimmune disease requiring systemic treatment within 2 years prior to initial administration, or as an autoimmune disease that can recur or for which treatment is planned determined by the investigator.
  • Active or past history of definite inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
  • History of immunodeficiency; those who test positive for HIV antibody; current chronic use of systemic corticosteroids or immunosuppressive agents.
  • Known active tuberculosis (TB) (suspected of having active TB need to undergo clinical examination for exclusion of such possibility); known active syphilis infection.
  • Known history of allotransplantation and allogeneic hematopoietic stem cell transplantation.
  • Has known active Hepatitis B or Hepatitis C.
  • Active or untreated CNS metastases.
  • Subjects with peripheral neuropathy.
  • Unresolved toxicity from prior anti-tumor therapy, defined as toxicity that has not recovered .
  • Received a live vaccine within 30 days before the first dose or planned to receive a live vaccine during the study.
  • Known allergy to any study drug component; known history of serious hypersensitivity to other monoclonal antibodies.
  • Pregnant or nursing (lactating) women.

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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