NCT05363709进行中（未招募）2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To establish the Overall survival.
研究概览
简要总结
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.
详细描述
Objectives:
Primary Objective:
To assess whether anti-PD1 will lead to the clearance of the virus in the plasma cfDNA in HPV+ OPC patients with persistent cfDNA 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject must meet all of the following applicable inclusion criteria to participate in this study:
- •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.
- •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.
- •Stage I-III per AJCC 8th edition
- •Positive p16 immunohistochemistry or HPV testing, or p16/HPV status unknown with patients having a less than 10 pack-year smoking history
- •Age ≥ 18 years at the time of consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1 for patients who receive treatment
- •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).
- •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
- •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.
- •Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study.
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Prior treatment history with anti-PD-1 or anti-PD-L1 therapies are not allowed.
- •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.
- •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.
- •Active rheumatological or autoimmune conditions requiring systemic treatment, such as steroids.
- •Any evidence of current interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids.
研究组 & 干预措施
Balstilimab
Experimental
Participants will receive Balstilimab by vein over about 30 minutes on Days 1 and 15 of each cycle (every 2 weeks)
干预措施: Balstilimab (Drug)
结局指标
主要结局
To establish the Overall survival.
时间窗: through study completion, an average of 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
HPV-based Screening Among Women 23-29 Years of AgeHuman Papilloma VirusCervical CancerCervical Intraepithelial NeoplasiaNCT05229679Karolinska Institutet180,000
招募中
2 期
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)HPVOropharynx CancerHPV-Related CarcinomaHPV-Related MalignancyHPV Positive Oropharyngeal Squamous Cell CarcinomaNCT05307939Memorial Sloan Kettering Cancer Center30
招募中
2 期
HPV Vaccine, Imiquimod, and Metformin Combination TrialCervical CarcinomaVaginal CarcinomaVulvar CarcinomaHPV (Human Papillomavirus)-Associated CarcinomaNCT06686043Baylor College of Medicine85
已完成
2 期
Induction Chemotherapy Followed by Chemoradiotherapy for Head and Neck CancerHead and Neck CancerNCT01716195University of California, Davis18
已完成
1 期
Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult SubjectsNipah Virus InfectionNCT06221813Public Health Vaccines LLC120