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

NCT04736810 | Completed Phase 2

• 1 other identifier: AK105-205
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Immunotherapy; Anti-PD-1 antibody; Nasopharyngeal Carcinoma; VEGF

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is the proportion of subjects with CR or PR based on RECIST v1.1.

  up to 2 years

Secondary Outcomes (6)

• Progression-free survival (PFS)

  up to 2 years

• Disease control rate (DCR)

  up to 2 years

• Duration of response (DoR)

  up to 2 years

• Overall survival (OS)

  up to 2 years

• Observed concentrations of AK105

  From first dose of AK105 through 90 days after last dose of AK105.

Study Arms (1)

AK105 plus Gemcitabine and Anlotinib Hydrochloride

EXPERIMENTAL

Biological: AK105; Drug: Cisplatin; Drug: Gemcitabine; Drug: Anlotinib hydrochloride

Interventions

AK105 BIOLOGICAL

IV infusion

AK105 plus Gemcitabine and Anlotinib Hydrochloride

Cisplatin DRUG

IV infusion

AK105 plus Gemcitabine and Anlotinib Hydrochloride

Gemcitabine DRUG

IV infusion

AK105 plus Gemcitabine and Anlotinib Hydrochloride

Anlotinib hydrochloride DRUG

Oral administration

AK105 plus Gemcitabine and Anlotinib Hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead
• Akeso Tiancheng, Inc: collaborator

Study Sites (1)

Cancer Hospital of the University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiaozhong Chen, MD

  Cancer Hospital of The University of Chinese Academy of Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 3, 2021
• Study Start: February 25, 2021
• Primary Completion: June 9, 2022
• Study Completion: December 18, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

CN (1)