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Checkpoint Inhibitor
Treatment (bintrafusp alfa, SBRT) for Head and Neck Squamous Cell Carcinoma
Phase 1 & 2
Waitlist Available
Led By Renata Ferrarotto
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying bintrafusp alfa and stereotactic body radiation therapy to see how well they work in treating patients with recurrent or second primary head and neck squamous cell cancer.
Eligible Conditions
- Head and Neck Squamous Cell Carcinoma
- Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Distant metastases rate
Fibrosis-related functional outcomes
Fibrosis-related toxicities
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (bintrafusp alfa, SBRT)Experimental Treatment4 Interventions
Patients receive bintrafusp alfa IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Beginning day 15 of cycle 1, patients also undergo SBRT over 5 fractions once QOD for 2 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Bintrafusp Alfa
2021
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,639 Previous Clinical Trials
40,930,481 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,965 Previous Clinical Trials
1,804,916 Total Patients Enrolled
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
166 Total Patients Enrolled
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