ISA101b for Carcinoma, Squamous Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Carcinoma, Squamous Cell+2 More
ISA101b - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare cemiplimab to cemiplimab plus ISA101b to see if the addition of ISA101b helps cemiplimab work better.

Eligible Conditions
  • Carcinoma, Squamous Cell
  • HPV16 Positive
  • Squamous cell carcinoma

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 25months

25 months
Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 "Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0".
25months
Duration of response (DOR) by independent review in subjects randomized to receive ISA101b plus cemiplimab compared to placebo plus cemiplimab.
Overall Response Rate

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Active ISA101b and cemiplimab.
1 of 2
Placebo and cemiplimab
1 of 2

Experimental Treatment

Non-Treatment Group

194 Total Participants · 2 Treatment Groups

Primary Treatment: ISA101b · Has Placebo Group · Phase 2

Active ISA101b and cemiplimab.Experimental Group · 2 Interventions: ISA101b, Cemiplimab · Intervention Types: Biological, Drug
Placebo and cemiplimabPlaceboComparator Group · 2 Interventions: Cemiplimab, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ISA101b
2018
Completed Phase 2
~10
Cemiplimab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 25months

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
543 Previous Clinical Trials
199,270 Total Patients Enrolled
17 Trials studying Carcinoma, Squamous Cell
2,194 Patients Enrolled for Carcinoma, Squamous Cell
ISA PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
254 Total Patients Enrolled
2 Trials studying Carcinoma, Squamous Cell
136 Patients Enrolled for Carcinoma, Squamous Cell
Bonnie S. Glisson, MD, BSPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
84 Total Patients Enrolled
2 Trials studying Carcinoma, Squamous Cell
50 Patients Enrolled for Carcinoma, Squamous Cell

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years of age or older.
You are willing and able to comply with the study requirements.
HPV-16 genotyping will be determined by the specified central reference laboratory.
You have a performance status of 0-1.
You have measurable disease by CT or MRI per RECIST 1.1 criteria.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 24th, 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.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
M. D. Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%