Pembrolizumab for Oropharyngeal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oropharyngeal Cancers+14 MorePembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding the immunotherapy drug pembrolizumab to standard radiation therapy improves outcomes for patients with head and neck squamous cell carcinoma.

Eligible Conditions
  • Oropharyngeal Cancers
  • Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Metastatic Oropharynx Cancer
  • Head and Neck Cancer
  • Neck Tumor
  • Cancer Metastasis
  • Advanced Cancer
  • Oropharyngeal Cancer
  • Neoplasm Recurrence
  • Metastatic Cancer
  • Oropharyngeal Cancer, Stage III
  • Tumors
  • Oral Cancers
  • Recurrent Oropharynx Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

3 months
Acute toxicity
3 years
Late toxicity
PD-L1 expression correlations
Patterns of failure
overall survival
progression-free survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Parkinsonism
100%Urinary tract infection
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Parkinsonism with 100%, Urinary tract infection with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

Control-radiotherapy/cisplatin
1 of 2
Experimental-Radiotherapy/pembrolizumab
1 of 2

Active Control

Experimental Treatment

114 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Experimental-Radiotherapy/pembrolizumabExperimental Group · 2 Interventions: Radiation therapy, Pembrolizumab · Intervention Types: Radiation, Drug
Control-radiotherapy/cisplatinActiveComparator Group · 2 Interventions: Cisplatin, Radiation therapy · Intervention Types: Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2840
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,673 Previous Clinical Trials
4,958,790 Total Patients Enrolled
2 Trials studying Oropharyngeal Cancers
1,952 Patients Enrolled for Oropharyngeal Cancers
Loren Mell, MDLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity.
You have oropharyngeal squamous cell carcinoma.
You have a p16+ squamous cell carcinoma of the oral cavity.
You have measurable disease based on RECIST 1.1.
You have hematologic function within 28 days prior to registration.
You are female and of childbearing potential.