2022-500652-37-00
进行中（未招募）
2 期
A MULTICOHORT, OPEN LABEL, PHASE 2 STUDY OF BOTENSILIMAB (AGEN1181) FOR TREATMENT OF ADVANCED MELANOMA REFRACTORY TO PRIOR CHECKPOINT INHIBITOR THERAPY
概览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Agenus Inc.
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- 1. Objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
概览
简要总结
To evaluate the clinical efficacy of botensilimab as monotherapy and in combination with balstilimab.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Cohort A only: Prior treatment with anti-programmed cell death protein (ligand) 1 (anti-PD-L1) therapy (e.g., pembrolizumab or nivolumab) for at least 6 weeks, and radiologic progression confirmed by 2 scans at least 4 weeks apart, or if symptomatic due to progressive malignancy, then 1 scan showing progression is sufficient.
- •Cohort A only: Progression must be either on treatment with anti-PD-L1 regimen or ≤ 12 weeks from last anti-PD-L1 dose in metastatic setting or ≤ 24 weeks from completion of therapy in adjuvant/neoadjuvant setting.
- •Cohort A only: For Part 2 only, no intervening anti-cancer therapy between the last course of anti-PDL1 treatment and the first dose of study treatment except for local measures (eg, surgical excision, biopsy, focal radiation therapy), or BRAF ± MEK inhibition when applicable in BRAF mutant patients.
- •Cohort B only: Prior treatment with first generation anti-CTLA-4 therapy (e.g., ipilimumab or tremelimumab), and prior treatment with anti-PD-L1 for at least 6 weeks.
- •Cohort B only: Progression on most recent anti-neoplastic therapy.
- •Cohort B only: For Part 2 only, no more than 3 prior lines of therapy in the metastatic setting for BRAF mutation and no more than 2 prior lines of therapy in the metastatic setting in the BRAF wild type.
- •Cohorts A and B: Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.
- •Cohorts A and B: ≥ 18 years of age.
- •Cohorts A and B: Histological confirmation of Stage III (unresectable) or Stage IV cutaneous melanoma, as per the AJCC 8th edition staging system.
- •Cohorts A and B: Willing and able to comply with the requirements of the protocol
排除标准
- •Cohort A only: Received prior anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) therapy.
- •Cohorts A and B: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
- •Cohorts A and B: Active brain metastases or leptomeningeal metastases with the following exceptions: a. Treated brain metastases require a) surgical resection, or b) stereotactic radiosurgery. These patients must be off steroids ≥ 10 days prior to randomization for the purpose of managing their brain metastases. Repeat brain imaging following surgical resection or stereotactic radiosurgery is not required if their last brain MRI is within screening window. Whole-brain radiation is not allowed. b. Untreated isolated brain metastases that are too small for treatment by surgical resection or stereotactic radiosurgery (e.g., 1-2 mm) and/or of uncertain etiology are potentially eligible but need to be discussed with and approved by the study Medical Monitor.
- •Cohorts A and B: Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment (i.e., patients with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the patient has no evidence of disease). Patients with history of prior early-stage basal/squamous cell skin cancer, low-risk prostate cancer eligible for active surveillance or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
- •Cohorts A and B: A WOCBP who is pregnant or breastfeeding.
- •Cohorts A and B: Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D
- •Cohorts A and B: Uncontrolled infection with HIV. Patients on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.
- •Cohorts A and B: Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for HBV at screening is not required.
- •Cohorts A and B: Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for HCV at screening is not required.
- •Cohorts A and B: Incomplete resolution of clinically significant AEs related to most recent therapy/intervention prior to enrollment.
结局指标
主要结局
1. Objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
1. Objective response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
次要结局
- 1. Progression-free survival (PFS), defined as the time from enrollment until disease progression or death, whichever comes first, quantified as a rate at 6 and 12 months.
- 2. Duration of response (DOR), defined as the time from first objective response until progression of disease or death, whichever comes first, quantified as median DOR.
- 3. Overall survival (OS) time, defined as the time from enrollment until death, whichever comes first, quantified as median OS.
研究者
Agenus, Inc. Clinical Trial Information
Scientific
Agenus Inc.
研究点 (26)
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