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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is more effective and has fewer side effects than the current standard of care.

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.Check my eligibility
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).See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Adverse event (AE)
Anti-drug antibodies (ADA)
Blood EBV level
+6 more

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

Find a Location

Who is running the clinical trial?

AkesoLead Sponsor
98 Previous Clinical Trials
15,995 Total Patients Enrolled
Xiaozhong Chen, MDPrincipal InvestigatorCancer Hospital of The University of Chinese Academy of Sciences
4 Previous Clinical Trials
784 Total Patients Enrolled
David G. Pfister, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
203 Total Patients Enrolled

Media Library

Penpulimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04974398 — Phase 3
Nasopharyngeal Cancer Research Study Groups: Group A, Group B
Nasopharyngeal Cancer Clinical Trial 2023: Penpulimab Highlights & Side Effects. Trial Name: NCT04974398 — Phase 3
Penpulimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04974398 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any existing research papers on Penpulimab?

"Currently, there are 1020 ongoing clinical trials for the drug penpulimab. Of these trials, 349 are in phase 3. Additionally, there are 52413 different locations around the world where these trials are taking place."

Answered by AI

Does this research require that participants be of a certain age?

"The age limit for participants in this trial is 12 years or older, and 75 years or younger."

Answered by AI

To what purpose is Penpulimab typically employed?

"Penpulimab is most effective in treating neoplasm metastasis, however it can also provide relief for patients with small cell lung cancer, urinary bladder cancer, and advanced testicular cancer."

Answered by AI

Are researchers presently looking for new participants for this clinical trial?

"Correct, the clinical trial is still looking for patients. The listing on clinicaltrials.gov shows that it was posted on 8/16/2021 and was last edited on 9/30/2022. The trial is looking for 298 participants at 6 sites."

Answered by AI

Is this clinical trial popular in North America?

"Currently, there are 6 clinical trial sites enrolling patients for this study. They are situated in Duarte, Miami, Ann Arbor, and 6 other locations. If you are thinking about participating in this trial, please choose the site that is most conveniently located for you to reduce travel-related demands."

Answered by AI

Could I be a test subject for this experiment?

"This trial is looking for 298 people, between the ages of 12 and 75, who have nasopharyngeal carcinoma. Patients must also meet the following criteria:Main study:- Age of ≥ 18 years and ≤ 75 years at the time of enrollment- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1- Voluntarily signed written Informed Consent Form(ICF)Substudy:- Age of ≥ 12 years and < 18 years- Weight≥ 35KG- Expected survival of ≥ 3 months- Histologically"

Answered by AI
~83 spots leftby Mar 2025