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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 The Oral Rinse And/Or Plasma cfDNA After Definitive Therapy

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ClinicalTrials.gov Identifier: NCT05363709
Recruitment Status : Not yet recruiting
First Posted : May 6, 2022
Last Update Posted : December 7, 2022
Agenus Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
HPV Oropharyngeal Cancer Drug: Balstilimab Phase 2

Detailed Description:


Primary Objective:

To assess whether adjuvant anti-PD1 will lead to the clearance of the virus in the oral rinse and/or plasma cfDNA in HPV+ OPC patients with persistent HPV following definitive therapy

Secondary Objectives:

  • One-year recurrence-free survival (1-yr RFS),
  • 2-year RFS (2-yr RFS),
  • Overall survival (2-yr OS),
  • Safety and tolerability
  • Compliance
  • Quality of life (EORTC C30 will be utilized)

Correlative/Exploratory Objectives:

  • Time to viral clearance in the oral rinse and plasma cfDNA with anti-PD1 treatment
  • The concordance between plasma HPV and oral rinse HPV at diagnosis, post-definitive treatment and during adjuvant treatment
  • The correlation between tumor mutations and persistence of HPV in oral rinse/cfDNA.
  • The correlation between recurrence site (loco-regional vs. distant metastasis) and oral rinse vs.

plasma HPV detection

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 The Oral Rinse And/Or Plasma cfDNA After Definitive Therapy
Estimated Study Start Date : October 30, 2023
Estimated Primary Completion Date : February 15, 2028
Estimated Study Completion Date : February 15, 2028

Arm Intervention/treatment
Experimental: Balstilimab
Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)
Drug: Balstilimab
Given by Vein (IV)
Other Name: Balstilimab IB

Primary Outcome Measures :
  1. To establish the Overall survival. [ Time Frame: through study completion, an average of 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  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. Age ≥ 18 years at the time of consent.
  3. 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.
  4. Stage I-III per AJCC 8th edition HPV-positive tumor status confirmed by p16 immunohistochemistry, or HPV testing, or HPV status unknown with patients having a less than 10 pack-year smoking history

6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for patients who receive treatment (Appendix A) 7. Prior radiation or surgery to localized head and neck cancers are allowed. 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.

Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

  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).

    Screening for chronic conditions is not required.

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363709

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Contact: Xiuning Le, MD (713) 792-6980 xle1@mdanderson.org

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: Xiuning Le, MD    713-792-6980    xle1@mdanderson.org   
Principal Investigator: Xiuning Le, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Agenus Inc.
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Principal Investigator: Xiuning Le, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05363709    
Other Study ID Numbers: 2021-1077
NCI-2022-03805 ( Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry )
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: December 7, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases