A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT04974398
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
296 participants
INTERVENTIONAL
2021-08-16
2026-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Group A (study group): Penpulimab plus cisplatin/carboplatin and gemcitabine
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.
Group B
Group B (control group): Placebo plus cisplatin/carboplatin and gemcitabine
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Principal Investigators
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Chaosu Hu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Xiaozhong Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital of The University of Chinese Academy of Sciences
Locations
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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
Countries
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Other Identifiers
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AK105-304
Identifier Type: -
Identifier Source: org_study_id
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