What side effects are associated with this type of intervention?

Common treatments for nasopharyngeal cancer, particularly those involving PD-1 inhibitors like Penpulimab combined with chemotherapy, are associated with several side effects. PD-1 inhibitors can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy can lead to neutropenia, fatigue, stomatitis, and hypertension. These side effects reflect the combined impact of immune modulation and cytotoxic effects of the treatment regimen.

What prior FDA approvals exist?

The FDA has approved several PD-1 inhibitors for the treatment of various cancers, including pembrolizumab and nivolumab. These drugs have shown efficacy in treating head and neck cancers, which are related to nasopharyngeal cancer. Pembrolizumab, in particular, has been approved for recurrent or metastatic head and neck squamous cell carcinoma, demonstrating significant improvements in overall survival and progression-free survival. While specific FDA approvals for nasopharyngeal cancer may not be detailed, the use of PD-1 inhibitors like pembrolizumab and nivolumab in related cancers suggests a promising potential for similar treatments in nasopharyngeal cancer.

What other types of research exist?

Promising alternatives to Penpulimab for Nasopharyngeal Cancer patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors with demonstrated efficacy in various cancers. Additionally, combination therapies such as Pembrolizumab plus chemotherapy or Pembrolizumab plus Cetuximab are being investigated and show potential.

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Monoclonal Antibodies

Penpulimab for Nasopharyngeal Cancer

Phase 3

Recruiting

Led By Xiaozhong Chen, MD

Research Sponsored by Akeso

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed nasopharyngeal carcinoma

Has adequate organ function

Must not have

Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and other treatments against tumor immune mechanism

Has known active Hepatitis B or Hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Possible side effects include allergic reactions to the drug components, fatigue, digestive issues due to chemotherapy, potential immune-related adverse events from Penpulimab such as inflammation in organs similar to autoimmune conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis is nasopharyngeal carcinoma.

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My organs are functioning well.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am between 12 and 18 years old and weigh at least 35KG.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received immunotherapy for my cancer before.

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I have an active Hepatitis B or C infection.

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I have nerve damage in my hands or feet.

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My cancer is nasopharyngeal adenocarcinoma or sarcoma.

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I have had a transplant using donor cells.

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I have or had Crohn's disease or ulcerative colitis.

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I have a weak immune system or I am taking medication that weakens my immune system.

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I have brain metastases that are either active or not yet treated.

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I have not received a live vaccine in the last 30 days nor plan to during the study.

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I still have side effects from previous cancer treatments that haven't gone away.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS)

Secondary study objectives

Adverse event (AE)

Anti-drug antibodies (ADA)

Blood EBV level

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Penpulimab

2022

Completed Phase 2

~70

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Nasopharyngeal Cancer (NPC) include PD-1 inhibitors like Penpulimab and chemotherapy. PD-1 inhibitors work by blocking the programmed cell death protein 1 (PD-1) pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, PD-1 inhibitors enable the immune system to recognize and attack cancer cells more effectively. Chemotherapy, on the other hand, uses drugs to kill rapidly dividing cancer cells or stop their growth. These treatments are crucial for NPC patients as they target the cancer cells directly and enhance the body's immune response, potentially leading to better outcomes and prolonged survival.

Targeting Mutant KRAS in Pancreatic Cancer: Futile or Promising?Molecular-targeted first-line therapy for advanced gastric cancer.Characteristics of Real-World Metastatic Non-Small Cell Lung Cancer Patients Treated with Nivolumab and Pembrolizumab During the Year Following Approval.