ISA101B for Squamous Cell Carcinoma of the Oropharynx

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous Cell Carcinoma of the OropharynxISA101B - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new combination of drugs to see if they are effective in treating cancer.

Eligible Conditions
  • Squamous Cell Carcinoma of the Oropharynx

Treatment Effectiveness

Effectiveness Progress

1 of 3

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REGN6569
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Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 20-25 monhts

20-25 monhts
Objective Response Rate based on radiographic response

Trial Safety

Safety Progress

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

Similar Trials

1
Cemiplimab-Rwlc
1
REGN6569
2
HPV ctDNA Assay

Trial Design

1 Treatment Group

single arm
1 of 1

Experimental Treatment

86 Total Participants · 1 Treatment Group

Primary Treatment: ISA101B · No Placebo Group · Phase 2

single armExperimental Group · 2 Interventions: ISA101b, ISA101B · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 20-25 monhts

Who is running the clinical trial?

ISA PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
362 Total Patients Enrolled
1 Trials studying Squamous Cell Carcinoma of the Oropharynx
194 Patients Enrolled for Squamous Cell Carcinoma of the Oropharynx
Regeneron PharmaceuticalsIndustry Sponsor
546 Previous Clinical Trials
199,729 Total Patients Enrolled
1 Trials studying Squamous Cell Carcinoma of the Oropharynx
194 Patients Enrolled for Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to comply with site visits and study-related procedures and requirements.
Patients must have histologically confirmed recurrent or metastatic HPV16 positive OPC
You have HPV16 genotyping as determined by a specified central reference laboratory
You have at least one measurable lesion by CT or MRI per RECIST version 1.1 criteria
You have a performance status of 0 or 1.
References

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