Immune-modulating stereotactic radiotherapy (iSBRT) for Squamous Cell Carcinoma of the Head and Neck

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Squamous Cell Carcinoma of the Head and NeckImmune-modulating stereotactic radiotherapy (iSBRT) - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for people with HPV-negative, PD-L1-positive head and neck cancer who have not had systemic treatment yet.

Eligible Conditions
  • Squamous Cell Carcinoma of the Head and Neck

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Surgery up to approximately 5 years

Week 9
Duration of Delayed Surgery Due to Treatment-Related Adverse Events
Rate of Delayed Surgery Due to Treatment-Related Adverse Events
Week 7
Objective Response Rate (ORR)
Week 7
Pathologic Complete Response (pCR), as Determined by Central Pathologic Review
Pathologic Response Rate (pRR), as Determined by Central Pathologic Review and Local Pathologic Review
pCR, as Determined by Local Pathologic Review
Year 5
Surgical Complication Rates
Year 5
Event-Free Survival (EFS)
Overall Survival (OS)
Year 5
Relapse-Free Survival (RFS)
Year 5
Percentage of Participants With Adverse Events
Week 12
Percentage of Participants with Immune-Related Adverse Events Grade >=3

Trial Safety

Trial Design

4 Treatment Groups

Atezo Monotherapy
1 of 4
Atezo + Tira +iSBRT
1 of 4
Atezo + Tira
1 of 4
Atezo + Tira + CP
1 of 4

Active Control

Experimental Treatment

180 Total Participants · 4 Treatment Groups

Primary Treatment: Immune-modulating stereotactic radiotherapy (iSBRT) · No Placebo Group · Phase 1 & 2

Atezo + Tira +iSBRTExperimental Group · 3 Interventions: Tiragolumab, Atezolizumab, Immune-modulating stereotactic radiotherapy (iSBRT) · Intervention Types: Drug, Drug, Radiation
Atezo + TiraExperimental Group · 2 Interventions: Tiragolumab, Atezolizumab · Intervention Types: Drug, Drug
Atezo + Tira + CPExperimental Group · 4 Interventions: Tiragolumab, Atezolizumab, Paclitaxel, Carboplatin · Intervention Types: Drug, Drug, Drug, Drug
Atezo Monotherapy
Drug
ActiveComparator Group · 1 Intervention: Atezolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 4
~7560
Paclitaxel
2011
Completed Phase 4
~6440
Carboplatin
2014
Completed Phase 3
~7230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: surgery up to approximately 5 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,362 Previous Clinical Trials
1,067,966 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,149 Previous Clinical Trials
876,056 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically confirmed Stage III-IVA squamous cell carcinoma of the head and neck.
You are eligible for resection.
You have not had a positive HIV test, negative HBsAb and negative HBcAb test, negative HCV at screening.