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

Status
Active
Cancer Type
Head and Neck Cancer
Trial Phase
Phase III
Eligibility
12 - 75 Years, Male and Female
Study Type
Treatment
NCT ID
NCT04974398
Protocol IDs
AK105-304 (primary)
NCI-2022-08325
Study Sponsor
Akeso

Summary

This study is a randomized, double-blind, multi-center phase III clinical study to
compare the efficacy and safety of penpulimab combined with chemotherapy and placebo
combined with chemotherapy in the first-line treatment of recurrent or metastatic
nasopharyngeal carcinoma.

Eligibility

  1. Voluntarily signed written Informed Consent Form(ICF).
  2. Main study: Age of = 18 years and = 75 years at the time of enrollment.
  3. Substudy: Age of = 12 years and < 18 years. Weight= 35KG.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Expected survival of = 3 months.
  6. Histologically or cytologically confirmed nasopharyngeal carcinoma.
  7. 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.
  8. At least one measurable lesion according to RECIST v1.1;
  9. Has adequate organ function.
  10. 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.

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.