A Randomized, Double-blind, Multi-center Phase III Study of Penpulimab (AK105) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Akeso56 sites in 5 countries296 target enrollmentAugust 16, 2021

ConditionsNasopharyngeal Carcinoma

InterventionsPenpulimab placebo

Overview

Phase: Phase 3
Intervention: Penpulimab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Akeso
Enrollment: 296
Locations: 56
Primary Endpoint: Progression-free survival (PFS)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

December 23, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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; subjects who have a local-regional recurrence and/or distant metastasis more than 6 months after the completion of prior radical treatment (radiotherapy with induction, concurrent, adjuvant chemotherapy)； No systemic treatment has been received for recurrent or metastatic diseases, not amendable to local treatment or have received local treatment for the local-regional recurrent disease
•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 Criteria

•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.

Arms & Interventions

Group A

Group A (study group): Penpulimab plus cisplatin/carboplatin and gemcitabine

Intervention: Penpulimab

Group B

Group B (control group): Placebo plus cisplatin/carboplatin and gemcitabine

Intervention: placebo

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: Up to 2 years

PFS assessed by BIRC based on RECIST v1.1 .

Secondary Outcomes

Duration of response (DoR)(Up to 2 years)
PD-L1 expression(Baseline (Tumor tissue samples must be provided to the research center or central laboratory prior to initial administration).)
Disease control rate (DCR)(Up to 2 years)
Maximum observed concentration (Cmax)(From first dose of penpulimab through 30 days after last dose of penpulimab)
Blood EBV level(Up to 2 years)
Overall survival(OS)(Up to 4 years)
Objective response rate (ORR)(Up to 2 years)
Adverse event (AE)(From the time of informed consent signed through 90 days after the last dose of penpulimab)
Anti-drug antibodies (ADA)(From first dose of penpulimab through 30 days after last dose of penpulimab)