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Balstilimab for Oropharyngeal Cancer
Phase 2
Recruiting
Led By Xiuning Le, MD
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
Patients must have adequate hematologic, coagulation, hepatic, and renal function for anti-PD1 treatment including: ANC ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, HgB ≥ 9 g/dL (may be with transfusion), Creatinine ≤ 1.5x ULN or creatinine clearance (measured via 24-hour urine collection) ≥ 40 mL/minute, Total Serum Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN), SGOT, SGPT ≤ 3 X ULN, SGOT, SGPT ≤ 5 X ULN, Females of childbearing potential must not be breast feeding and must have a negative pregnancy test during screening and 7 days prior to initiation of study treatment. The patient must agree to use adequate contraception
Persistent detection of cfDNA HPV (≥ 16 copies/mL) in the absence of clinically evident disease at 3, 6, or 9 months following definitive treatment (surgery, systemic therapy, and/or radiation therapy)
Must not have
Active rheumatological or autoimmune conditions requiring systemic treatment, such as steroids
Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if patients with a type of cancer called HPV+ OPC have a higher chance of the cancer coming back after treatment if they receive immune therapy.
Who is the study for?
This trial is for adults over 18 with HPV+ oropharyngeal cancer confirmed by biopsy, who've completed treatment but still have detectable HPV. They must be in good health otherwise, with proper organ function and non-smokers or light smokers. Women of childbearing age must not be pregnant, breastfeeding, and agree to use contraception.
What is being tested?
The study tests Balstilimab's ability to clear persistent HPV infection after standard cancer treatment in patients without visible disease. It aims to understand if clearing the virus can help control the cancer long-term.
What are the potential side effects?
Balstilimab may cause immune-related side effects such as inflammation in various organs, potential lung issues like pneumonitis, fatigue, and could affect liver enzymes. Specific side effect details will depend on individual patient reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I still have HPV DNA in my blood after treatment, but no visible cancer.
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My cancer is a type of throat cancer confirmed by lab tests.
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My cancer is at an early to mid-stage.
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I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on systemic treatment for an autoimmune or rheumatological condition.
Select...
I have never been treated with anti-PD-1 or anti-PD-L1 therapies.
Select...
I have or had lung inflammation not caused by an infection, treated with high-dose steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BalstilimabExperimental Treatment1 Intervention
Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,626 Total Patients Enrolled
Agenus Inc.Industry Sponsor
52 Previous Clinical Trials
4,796 Total Patients Enrolled
Xiuning Le, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on systemic treatment for an autoimmune or rheumatological condition.I still have HPV DNA in my blood after treatment, but no visible cancer.My cancer is HPV positive or I've smoked less than 10 pack-years if HPV status is unknown.I am a man who can father children and will use birth control during the study.My cancer is a type of throat cancer confirmed by lab tests.I have never been treated with anti-PD-1 or anti-PD-L1 therapies.I am 18 years old or older.My cancer is at an early to mid-stage.I have or had lung inflammation not caused by an infection, treated with high-dose steroids.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any severe illnesses or infections that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Balstilimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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