Penpulimab for Nasopharyngeal Cancer
Recruiting in Palo Alto (17 mi)
+59 other locations
Overseen ByChaosu Hu, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Akeso
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment combining penpulimab and chemotherapy for patients whose nasopharyngeal cancer has returned or spread. Penpulimab helps the immune system better recognize and fight cancer cells.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it excludes those who have had recent investigational drug treatments or certain medical conditions. It's best to discuss your specific medications with the trial investigators.
What data supports the idea that Penpulimab for Nasopharyngeal Cancer is an effective treatment?
The available research does not provide specific data on Penpulimab for Nasopharyngeal Cancer. However, it discusses other treatments like Toripalimab and anti-EGFR antibodies, which are used for similar conditions. These studies suggest that new treatments, including PD-1 inhibitors like Toripalimab, show promise in improving outcomes for patients with recurrent or metastatic nasopharyngeal carcinoma compared to standard chemotherapy. This implies that similar drugs, such as Penpulimab, might also be effective, but specific data on Penpulimab is not provided in the available research.
12345What safety data is available for Penpulimab in treating nasopharyngeal cancer?
The provided research does not contain specific safety data for Penpulimab (also known as AK-105, AK105, Anniko, Annikol) in the treatment of nasopharyngeal cancer. The studies focus on other treatments such as toripalimab, cetuximab, and sintilimab, assessing their safety and efficacy in nasopharyngeal carcinoma.
12678Is the drug Penpulimab a promising treatment for nasopharyngeal cancer?
Penpulimab is a promising drug for nasopharyngeal cancer because it is a new type of medicine that helps the body's immune system fight cancer. It has already been approved in China for treating another type of cancer, and it is being tested for nasopharyngeal cancer. This shows that it has potential to be an effective treatment.
89101112Eligibility Criteria
Adults aged 18-75 with recurrent or metastatic nasopharyngeal carcinoma, who haven't had systemic treatment for this condition and are not suitable for local therapy. They should have a life expectancy of at least 3 months, an ECOG performance status of 0 or 1 (meaning they are fully active or restricted in physically strenuous activity but can do light work), and adequate organ function. Participants must be willing to use effective contraception.Inclusion Criteria
At least one measurable lesion according to RECIST v1.1
My cancer diagnosis is nasopharyngeal carcinoma.
I have nasopharyngeal cancer that has spread and cannot be treated locally, or it came back 6 months after treatment.
+7 more
Exclusion Criteria
I have received immunotherapy for my cancer before.
Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing
I have an active Hepatitis B or C infection.
+13 more
Participant Groups
The trial is testing Penpulimab combined with chemotherapy versus a placebo combined with chemotherapy in patients with nasopharyngeal carcinoma. It's randomized (participants are assigned by chance) and double-blind (neither the researchers nor participants know who gets which treatment).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group AExperimental Treatment1 Intervention
Group A (study group): Penpulimab plus cisplatin and gemcitabine
Group II: Group BPlacebo Group1 Intervention
Group B (control group): Placebo plus cisplatin and gemcitabine
Penpulimab is already approved in China for the following indications:
🇨🇳 Approved in China as Penpulimab for:
- Classic Hodgkin’s lymphoma
- Locally advanced or metastatic squamous non-small cell lung cancer
- Nasopharyngeal carcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Miami Medical CenterMiami, FL
Memorial Sloan KetteringNew York, NY
Alberta Health Services (Tom Baker Cancer Centre)Calgary, Canada
City of HopeDuarte, CA
More Trial Locations
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Who Is Running the Clinical Trial?
AkesoLead Sponsor
References
Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). [2023]As yet, no checkpoint inhibitor has been approved to treat nasopharyngeal carcinoma (NPC). This study was aimed to evaluate the antitumor activity, safety, and biomarkers of toripalimab, a new programmed death-1 (PD-1) inhibitor for recurrent or metastatic NPC (RM-NPC) refractory to standard chemotherapy.
Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. [2022]Label="BACKGROUND">Toripalimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1. We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC).
Efficacy and survival analysis of nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced nasopharyngeal carcinoma. [2023]This study investigated the curative effect of adding nimotuzumab (NTZ) in patients with locally advanced nasopharyngeal carcinoma (NPC) who were treated with concurrent chemoradiotherapy (CCRT) and explored significant prognostic factors of NPC.
Adjunctive PD-1 inhibitor versus standard chemotherapy in recurrent or metastatic nasopharyngeal carcinoma: a systematic review and meta-analysis. [2022]To investigate whether Adjunctive PD-1 inhibitors have improved clinical outcomes compared to chemotherapy alone in platinum-pretreated and platinum-naive recurrent or metastatic nasopharyngeal carcinoma (R/M NPCA).
Anti-epidermal growth factor receptor monoclonal antibody plus palliative chemotherapy as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma. [2021]Platinum-based chemotherapy is the standard of care as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC); however, the prognosis of patients with RM-NPC remains poor. The aim of this study was to evaluate the role of anti-epidermal growth factor receptor (anti-EGFR) antibody plus chemotherapy for RM-NPC.
Combination treatment with cetuximab in advanced nasopharyngeal carcinoma patients: a meta-analysis. [2022]Cetuximab, an anti-epidermal growth factor receptor monoclonal antibody, carries the potential for combination treatment against nasopharyngeal carcinoma (NPC). We conducted a meta-analysis to assess the possible benefits and safety between the combination treatment with cetuximab and conventional treatment in NPC patients. Skin toxicity (ST) associated with additional cetuximab was evaluated as well.
Anti-PD1 checkpoint inhibitor with or without chemotherapy for patients with recurrent and metastatic nasopharyngeal carcinoma. [2021]To compare the efficacy and safety of anti-PD1 checkpoint inhibitor plus chemotherapy with anti-PD1 checkpoint inhibitor alone in recurrent and metastatic nasopharyngeal carcinoma (R/M NPC) progressing after first or subsequent-line therapy.
Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: an open-label phase 2 study. [2023]There are limited treatment options for patients with metastatic nasopharyngeal carcinoma (mNPC) after failure of platinum-based chemotherapy. In this trial, we assessed the efficacy and safety of sintilimab plus bevacizumab in patients with mNPC where platinum-based chemotherapy has been ineffective.
Penpulimab: First Approval. [2022]Penpulimab (®) is a humanised anti-programmed cell death 1 (PD-1) monoclonal antibody developed by Akeso Biopharma, in collaboration with Chia Tai Tianqing (a subsidiary of SinoBiopharm), for the treatment of various cancers, including Hodgkin's lymphoma, nasopharyngeal cancer, non-small cell lung cancer (NSCLC) and solid tumours. Penpulimab is an immunoglobulin G1 monoclonal antibody engineered to completely eliminate Fcγ receptor binding and Fc-mediated effector functions that can compromise anti-tumour activity. In August 2021, penpulimab received its first approval in China for the treatment of adult patients with relapsed or refractory classic Hodgkin's lymphoma who have undergone at least second-line chemotherapy. Penpulimab is under regulatory review for nasopharyngeal cancer and NSCLC in China. Clinical studies of penpulimab are underway for various cancers in China and Australia. This article summarizes the milestones in the development of penpulimab leading to this first approval for relapsed or refractory classic Hodgkin's lymphoma.
Long-Term Results of Concurrent Chemoradiotherapy for Advanced N2-3 Stage Nasopharyngeal Carcinoma. [2019]N-stage is related to distant metastasis in nasopharyngeal carcinoma (NPC) patients. The purpose of this study was to evaluate the efficacy and toxicity of different nedaplatin-based chemotherapy regimens in advanced N2-3 stage NPC patients treated with intensity modulated radiation therapy (IMRT).
The Association between Metformin and the Cancer-Specific Mortality Rate in Nasopharyngeal Cancer Patients: Real-World Evidence. [2023]Nasopharyngeal cancer is a common cancer in East and South Asia. The radiotherapy and chemotherapy regimen has advanced in recent years. However, many patients still suffer from local recurrence and distant metastasis; thus, identifying medication that can be combined with standard treatment to improve the treatment outcomes in nasopharyngeal cancer patients is an unmet need.
Concurrent chemoradiotherapy with carboplatin followed by carboplatin and 5-fluorouracil in locally advanced nasopharyngeal carcinoma. [2021]This study aimed to evaluate acute major toxicities, the response rate, 3-year overall survival and progression-free survival rate of locally advanced nasopharyngeal carcinoma patients on concurrent carboplatin chemoradiotherapy followed by carboplatin and 5-fluorouracil.