A Randomized, 2-Arm Study to Evaluate the Efficacy and Safety of CRB-701 Compared With Investigator's Choice of Capecitabine, Cetuximab, or Docetaxel in Participants With Recurrent or Metastatic Oropharyngeal Squamous Cell Carcinoma Previously Treated With Platinum-based Chemotherapy and a PD-(L)1 Inhibitor
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 29
- 主要终点
- Objective Response Rate (%)
研究概览
简要总结
The goal of this study is to understand whether CRB-701, a targeted form of chemotherapy called an anti-body drug conjugate, will work as a treatment for oropharyngeal (throat, tonsil) cancer. In patients who have already received platinum based chemotherapy or immunotherapy (using a check-point inhibitor) It will also learn about the safety of the drug and measure quality of life. The main questions it asks are:
- What proportion of participants respond to CRB-701 measured using scans (CT or MRI)
- What medical problems do participants experience when taking CRB-701.
Researchers will compare CRB-701 with standard of care medicines (drugs that are normally used this disease).
Participants will:
- Attend clinic every three weeks to receive infusions of CRB-701 or standard of care medicines until the cancer cannot be measured or is not controlled by the treatment they are receiving.
- Have a CT or MRI every 6 weeks to measure the effect on their cancer
- Complete questionnaires to assess their health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Sponsor personnel involved in making key trial decisions are masked to efficacy and patient level treatment arm allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological and/or cytological confirmed diagnosis of OPSCC arising from tonsils, base of tongue, soft palate and posterior pharyngeal wall, with evidence of metastatic or recurrent disease not amenable to standard therapy with curative intent.
- •Either second or third-line OPSCC patients who have progressed on or after receiving SOC therapy (that must have included platinum chemotherapy and an anti-PD-(L)1 antibody administered sequentially or together) OR received platinum chemotherapy and/or anti-PD-(L)1 therapy in the neoadjuvant or adjuvant setting or as part of definitive chemoradiation therapy, provided disease recurrence occurred less than 6 months after completion of the relevant systemic therapy.
- •ECOG PS of 0-1
- •Measurable disease as per RECIST v1.1, with at least one measurable lesion not previously irradiated unless unequivocal progression has been documented after radiation.
- •Life expectancy of greater than 12 weeks at time of enrollment, as per Investigator's assessment.
- •Signed informed consent
排除标准
- •Persistent CTCAE Grade >1 clinically significant toxicities related to prior antineoplastic therapies, excluding alopecia.
- •Significant active or chronic corneal disorders
- •Pre-existing Grade ≥2 peripheral neuropathy
- •Any other significant co-morbidities, disease, metabolic dysfunction, physical examination, or clinical laboratory finding that contraindicates the use of the investigational drug or may represent an unacceptable risk from treatment complications or may affect adherence to the study procedures or the interpretation of the results.
- •Pregnant or breastfeeding females
研究组 & 干预措施
CRB-701
3.6mg/Kg CRB-701 administered intravenously Q3W.
干预措施: CRB-701 (Drug)
Investigator's Choice monotherapy
Investigator's choice of capecitabine, cetuximab or docetaxel
干预措施: Cetuximab (EGFR inhibitor) (Drug)
Investigator's Choice monotherapy
Investigator's choice of capecitabine, cetuximab or docetaxel
干预措施: Docetaxel (Drug)
Investigator's Choice monotherapy
Investigator's choice of capecitabine, cetuximab or docetaxel
干预措施: capcitabine (Drug)
结局指标
主要结局
Objective Response Rate (%)
时间窗: Up to 24 months
Measured using RECIST version 1.1 by Blinded Independed Central Review (BICR)
Overall Survival (months)
时间窗: Approximately 3 years from randomization
Median time to death from any cause
次要结局
- Progression Free Survival (Months)(up to 24 months from randomization)
- Duration of Response (Months)(Up to approximately 2 years)
- Change in baseline in EORTC QLQ-C30 functional and symptom scales(up to approximately 2 years)
- Objective Response Rate (%)(Up to approximate 2 years)
- Time to Response (days)(up to approx 2 years)
- Time to Response (days)(up to approximately 2 years)
- Number of participants experiencing a treatment emergent adverse events(Up to approximately 2 years)
- Number of participants experiencing a serious treatment emergent adverse event(Up to approximately 2 years)
- Number of participants that had a treatment modification due to an adverse event(Up to approx. 2 years)
- Number of participants who discontinued study treatment due to a treatment emergent adverse event(Up to approximately 2 years)