Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04974398

PHASE3

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

Sponsor: Akeso

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

296

Start Date

2021-08-16

Completion Date

2026-12-23

Last Updated

2025-04-13

Healthy Volunteers

Conditions

Nasopharyngeal Carcinoma

Interventions

DRUG

Penpulimab

Arm A: Penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) +cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/ m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), 3 weeks (21 days) per cycle; followed by penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment.

DRUG

placebo

Arm B: Placebo (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2) or carboplatin (AUC 5) (administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), every 3 weeks (21 days) per cycle; followed by placebo(200 mg, administered on Day 1 of each cycle, Q3W) as maintenance treatment. Subjects in Arm B will have the opportunity to crossover to openlabel treatment with penpulimab monotherapy after radiographic disease progression.

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 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; 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. * 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.

Locations (56)

City of Hope

Duarte, California, United States

Winship Cancer Institute/Emory University

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

St Vincent's Public Hospital Sydney

Darlinghurst, New South Wales, Australia

Genesis Care North Shore

St Leonards, New South Wales, Australia

Sir Charles Gardner

Heidelberg, Victoria, Australia

Austin Health

Nedlands, Western Australia, Australia

Hospital de Câncer de Barretos - Fundação Pio XII

Barretos, REG1, Brazil

Grupo Oncoclínicas

Botafogo, REG1, Brazil

Hospital Bruno Born

Lajeado, REG1, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, REG1, Brazil

Centro de Estudos e Pesquisa de Hematologia

Santo André, REG1, Brazil

Instituto do Câncer do Estado de São Paulo (ICESP)

São Paulo, REG1, Brazil

Centro de Câncer A. C. Camargo

São Paulo, REG1, Brazil

Alberta Health Services (Tom Baker Cancer Centre)

Calgary, Alberta, Canada

Toronto Sunnybrook Hospital

Toronto, Ontario, Canada

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Cancer Hospital

Guiyang, Guizhou, China

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Hainan General Hospital

Haikou, Hainan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)