A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Phase II Study of Penpulimab Combined With Chemotherapy ± Anlotinib Hydrochloride in Patients With Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736810
• Other study ID #: AK105-205
• Status: Completed
• Phase: Phase 2
• Start date: March 4, 2021
• Est. completion date: December 18, 2023

Study information

• Verified date: April 2024
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, open-label, phase II study to evaluate the efficacy and safety of anti-PD-1 antibody Penpulimab (AK105) combined with chemotherapy ± anlotinib hydrochloride in the first-line treatment of patients with advanced nasopharyngeal carcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 18, 2023
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent form voluntarily.
• Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Expected life expectance = 3 months.
• Histologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
• Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
• At least one measurable tumor lesion per RECIST 1.1 criteria.
• Subjects must provide an available tumor tissue sample taken within 3 years prior to enrollment.
• Adequate organ function.
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
• Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product.

Exclusion Criteria:

• Other invasive malignancies within 2 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
• Is currently participating in a study of an investigational agent or using an investigational device.
• Has known active central nervous system (CNS) metastases.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study.
• Has an active infection requiring systemic therapy.
• Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
• History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
• Has undergone major surgery within 30 days of Study Day 1.
• Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
• Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Biological:
• AK105
IV infusion

Drug:
• Cisplatin
IV infusion
• Gemcitabine
IV infusion
• Anlotinib hydrochloride
Oral administration

Locations

Country	Name	City	State
China	Cancer Hospital of the University of Chinese Academy of Sciences	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Akeso	Akeso Tiancheng, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is the proportion of subjects with CR or PR based on RECIST v1.1.	up to 2 years
Secondary	Progression-free survival (PFS)	PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first).	up to 2 years
Secondary	Disease control rate (DCR)	DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.	up to 2 years
Secondary	Duration of response (DoR)	DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.	up to 2 years
Secondary	Overall survival (OS)	OS is defined as the time from the date of randomization to death from any cause.	up to 2 years
Secondary	Observed concentrations of AK105	The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.	From first dose of AK105 through 90 days after last dose of AK105.
Secondary	Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).	From first dose of AK105 through 90 days after last dose of AK105.