RECRUITING

BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Study to Assess the Effect of BALSTILIMAB (AGEN2034) on Viral Clearance in HPV-positive Oropharyngeal Cancer Patients With Persistent HPV Detection in Plasma cfDNA After Definitive Therapy

Quick Facts

Study Start:2023-10-18

Study Completion:2028-02-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05363709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Histologically or cytologically confirmed squamous cell carcinoma from oropharynx. note: patients with a clinical diagnosis of oropharyngeal cancer, awaiting a biopsy is eligible to consent for prescreening. 3. Stage I-III per AJCC 8th edition 4. Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history 5. Age ≥ 18 years at the time of consent. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for patients who receive treatment 7. 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). 8. Patients must have adequate hematologic, coagulation, hepatic, and renal function for anti-PD1 treatment. this includes: * 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 (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). * 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 9. 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. Note: women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following agespecific requirements must also apply: women \< 50 years old: they would be considered postmenopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) must also be in the post-menopausal range (as per the institution). Women ≥ 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses \> 1 year ago, or have had chemotherapyinduced menopause with \>1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy. 10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study.	1. Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed. 2. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active and uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 3. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement. 4. Active rheumatological or autoimmune conditions requiring systemic treatment, such as steroids. 5. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.

Inclusion Criteria

Exclusion Criteria

1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
2. Histologically or cytologically confirmed squamous cell carcinoma from oropharynx. note: patients with a clinical diagnosis of oropharyngeal cancer, awaiting a biopsy is eligible to consent for prescreening.
3. Stage I-III per AJCC 8th edition
4. Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history
5. Age ≥ 18 years at the time of consent.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for patients who receive treatment
7. 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).
8. Patients must have adequate hematologic, coagulation, hepatic, and renal function for anti-PD1 treatment. this includes:
* 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 (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
* 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
9. 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. Note: women will be considered post-menopausal if they have been amenorrheic for the past 12 months without an alternative medical cause. The following agespecific requirements must also apply: women \< 50 years old: they would be considered postmenopausal if they have been amenorrheic for the past 12 months or more following cessation of exogenous hormonal treatments. The levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) must also be in the post-menopausal range (as per the institution). Women ≥ 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses \> 1 year ago, or have had chemotherapyinduced menopause with \>1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy.
10. Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study.

1. Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed.
2. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol, or active and uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
3. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirement.
4. Active rheumatological or autoimmune conditions requiring systemic treatment, such as steroids.
5. Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.

Contacts and Locations

Study Contact

Luana Guimaraes de Sousa, MD

CONTACT

(832) 728-7849

lgsousa@mdanderson.org

Principal Investigator

Luana Guimaraes de Sousa, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Luana Guimaraes de Sousa, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18

Study Completion Date2028-02-15

Study Record Updates

Study Start Date2023-10-18

Study Completion Date2028-02-15

Terms related to this study

Additional Relevant MeSH Terms

HPV
Oropharyngeal Cancer