Pembrolizumab for Recurrent Head and Neck Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Recurrent Head and Neck Cancer+1 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer treatment that uses light-sensitive drugs and laser light to kill cancer cells.

Eligible Conditions
  • Recurrent Head and Neck Cancer
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: At 10-12 weeks

At 10-12 weeks
Objective target tumor response rates (Phase II)
Up to 30 days
Incidence of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)

Trial Safety

Safety Progress

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

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
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: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

2 Treatment Groups

Arm A (standard of care chemotherapy at doctor's discretion)
1 of 2
Arm B(porfimer sodium, I-PDT, SoC chemotherapy)
1 of 2

Active Control

Experimental Treatment

82 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Arm B(porfimer sodium, I-PDT, SoC chemotherapy)Experimental Group · 9 Interventions: Nivolumab, Interstitial Illumination Photodynamic Therapy, Cisplatin, Carboplatin, Cetuximab, Quality of Life Assessment, Pembrolizumab, Porfimer Sodium, Fluorouracil · Intervention Types: Biological, Procedure, Drug, Drug, Biological, Other, Biological, Drug, Drug
Arm A (standard of care chemotherapy at doctor's discretion)ActiveComparator Group · 7 Interventions: Nivolumab, Cisplatin, Carboplatin, Cetuximab, Quality of Life Assessment, Pembrolizumab, Fluorouracil · Intervention Types: Biological, Drug, Drug, Biological, Other, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Cisplatin
FDA approved
Carboplatin
FDA approved
Cetuximab
FDA approved
Pembrolizumab
FDA approved
Porfimer sodium
FDA approved
Fluorouracil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 10-12 weeks

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,564 Total Patients Enrolled
1 Trials studying Recurrent Head and Neck Cancer
270 Patients Enrolled for Recurrent Head and Neck Cancer
Roswell Park Cancer InstituteLead Sponsor
377 Previous Clinical Trials
29,465 Total Patients Enrolled
Kimberly Wooten, MDPrincipal InvestigatorRoswell Park Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
You have locally advanced or recurrent head and neck cancer and have failed to respond to standard therapy.
You have a tumor accessible for unrestricted illumination for PDT.
Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
You must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.