Pembrolizumab for Head Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Head Neoplasms+2 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.

Eligible Conditions

  • Head Neoplasms
  • Head and Neck Cancer
  • Lung Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 36 months

36 months
Adverse Events
Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
Health Related Quality of Life (HRQoL) assessment (Head and Neck Cancer)
Health Related Quality of Life (HRQoL) assessment (Lung Cancer)
Overall response rates
Progression Free Survival
Tumor immune microenvironment (TME) evaluation of biopsy tissues, via tumor markers

Trial Safety

Safety Progress

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

Trial Design

3 Treatment Groups

Squamous Lung Cancer
1 of 3
Non-Squamous Lung Cancer
1 of 3
Head and Neck Squamous Cell Carcinoma
1 of 3
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Squamous Lung CancerExperimental Group · 3 Interventions: Paclitaxel, Carboplatin, Pembrolizumab · Intervention Types: Drug, Drug, Drug
Non-Squamous Lung CancerExperimental Group · 3 Interventions: Pemetrexed, Carboplatin, Pembrolizumab · Intervention Types: Drug, Drug, Drug
Head and Neck Squamous Cell CarcinomaExperimental Group · 3 Interventions: 5Fluorouracil, Carboplatin, Pembrolizumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~6340
5Fluorouracil
2020
Completed Phase 3
~690
Pemetrexed
2014
Completed Phase 3
~5260
Carboplatin
2014
Completed Phase 3
~6570
Pembrolizumab
2017
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
Closest Location: Rutgers Cancer Institute of New Jersey · New Brunswick, NJ
Photo of new jersey 1Photo of new jersey 2Photo of new jersey 3
2013First Recorded Clinical Trial
0 TrialsResearching Head Neoplasms
163 CompletedClinical Trials

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
361 Previous Clinical Trials
60,037 Total Patients Enrolled
Missak Haigentz, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition).
You are eligible if you are ≥ 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.