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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04974398




Registration number
NCT04974398
Ethics application status
Date submitted
13/07/2021
Date registered
23/07/2021
Date last updated
3/04/2024

Titles & IDs
Public title
A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma
Scientific 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
Secondary ID [1] 0 0
AK105-304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Penpulimab
Treatment: Drugs - placebo

Experimental: Group A - Group A (study group): Penpulimab plus cisplatin and gemcitabine

Placebo Comparator: Group B - Group B (control group): Placebo plus cisplatin and gemcitabine


Treatment: Drugs: Penpulimab
Arm A: Penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin 80 mg/m2, 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 treatment cycle (Q3W), and then followed by penpulimab monotherapy as maintenance treatment, Q3W.

Treatment: Drugs: placebo
Arm B: Placebo (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2, administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/m2, on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), every 3 weeks (21 days) per treatment cycle and then followed by placebo monotherapy as maintenance treatment, Q3W. Subjects in Arm B will have the opportunity to crossover to open-label treatment with penpulimab monotherapy after radiographic disease progression.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Overall survival(OS)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Duration of response (DoR)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Disease control rate (DCR)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Adverse event (AE)
Timepoint [5] 0 0
From the time of informed consent signed through 90 days after the last dose of penpulimab
Secondary outcome [6] 0 0
Maximum observed concentration (Cmax)
Timepoint [6] 0 0
From first dose of penpulimab through 30 days after last dose of penpulimab
Secondary outcome [7] 0 0
Anti-drug antibodies (ADA)
Timepoint [7] 0 0
From first dose of penpulimab through 30 days after last dose of penpulimab
Secondary outcome [8] 0 0
PD-L1 expression
Timepoint [8] 0 0
Baseline (Tumor tissue samples must be provided to the research center or central laboratory prior to initial administration).
Secondary outcome [9] 0 0
Blood EBV level
Timepoint [9] 0 0
Up to 2 years

Eligibility
Key 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; 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.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2026
Actual
Sample size
Target
298
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
St Vincent's Public Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Genesis Care North Shore - St Leonards
Recruitment hospital [4] 0 0
Sir Charles Gardner - Heidelberg
Recruitment hospital [5] 0 0
Austin Health - Nedlands
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Brazil
State/province [5] 0 0
Reg1
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
China
State/province [8] 0 0
Anhui
Country [9] 0 0
China
State/province [9] 0 0
Fujian
Country [10] 0 0
China
State/province [10] 0 0
Guangdong
Country [11] 0 0
China
State/province [11] 0 0
Guangxi
Country [12] 0 0
China
State/province [12] 0 0
Guizhou
Country [13] 0 0
China
State/province [13] 0 0
Hainan
Country [14] 0 0
China
State/province [14] 0 0
Hubei
Country [15] 0 0
China
State/province [15] 0 0
Hunan
Country [16] 0 0
China
State/province [16] 0 0
Jiangxi
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
China
State/province [18] 0 0
Sichuan
Country [19] 0 0
China
State/province [19] 0 0
Yunnan
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Akeso
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04974398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chaosu Hu, MD
Address 0 0
Fudan University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zhifang Yao, MD
Address 0 0
Country 0 0
Phone 0 0
+86-0760-89873999
Fax 0 0
Email 0 0
clinicaltrials@akesobio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04974398