Balstilimab for Oropharyngeal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Oropharyngeal Cancers+2 More
Balstilimab - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This study aims to leverage this unique property of HPV+ OPC to detect possible minimal residual disease represented by persistent viral detection after the completion of definitive treatment. The study will offer adjuvant immune therapy to patients with persistent viral detection and evaluate the clearance of viral load. It will evaluate the rate of viral clearance with immune therapy and establish the link between viral clearance and long-term disease control.

Eligible Conditions

  • Oropharyngeal Cancers
  • HPV

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Oropharyngeal Cancers

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: through study completion, an average of 2 years

Year 2
To establish the Overall survival.

Trial Safety

Safety Progress

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

Other trials for Oropharyngeal Cancers

Trial Design

1 Treatment Group

Balstilimab
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Balstilimab · No Placebo Group · Phase 2

Balstilimab
Drug
Experimental Group · 1 Intervention: Balstilimab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 years
Closest Location: M D Anderson Cancer Center · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2003First Recorded Clinical Trial
2 TrialsResearching Oropharyngeal Cancers
465 CompletedClinical Trials

Who is running the clinical trial?

Agenus Inc.Industry Sponsor
34 Previous Clinical Trials
3,769 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,772 Previous Clinical Trials
1,795,192 Total Patients Enrolled
10 Trials studying Oropharyngeal Cancers
2,091 Patients Enrolled for Oropharyngeal Cancers
Xiuning Le, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
105 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a platelet count of at least 100,000/mm3.
You have a blood hemoglobin level of at least 9 g/dL (may be with transfusion).
Creatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute.
You have a total serum bilirubin level of ≤ 1.5 x ULN.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.