NCT06292689招募中2 期
A Phase II, Single-arm, Multicenter, Prospective Study of Cardunolizumab in Recurrent or Metastatic Vulvar and Vaginal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of cardunolizumab in combination with/without chemotherapy ± bevacizumab for recurrent or metastatic vulvar and vaginal cancers that are not amenable to radical treatment.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary enrolment in the study with written informed consent and ability to comply with protocol requirements visits and related procedures as specified in the protocol.
- •Age≥18 & ≤
- •Recurrent or metastatic vulvar and vaginal carcinoma not amenable to curative treatment, diagnosed histologically or cytologically, with a pathological type of squamous, adenocarcinoma or adenosquamous carcinoma.
- •Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. Lesions located in previously irradiated areas are considered measurable if they show progression in such lesions.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of at least 3 months.
- •Prior immunotherapy, targeted therapies are permitted if treatment has not been discontinued due to a grade ≥2 adverse event.
- •The end of prior systemic therapy must be ≥ 4 weeks or 5 half-lives, whichever is shorter, from the first dose of this study. and the treatment-related AE returned to CTCAE 5.0 ≤ Grade 1 (except alopecia and malaise).
- •All participants must provide an archived tumour tissue sample (formalin-fixed paraffin-embedded [FFPE] tissue wax block or a minimum of 5 unstained tumour tissue section samples, preferably newly obtained tumour tissue samples) within 2 years prior to randomisation.
- •Has adequate organ function.
- •Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
- •Ability to understand and sign written informed consent and to comply with programme visits and related procedures.
排除标准
- •Participants who have received prior systemic anticancer therapy (including study drug) within 4 weeks prior to the first dose of study treatment. Note: If participants have undergone major surgery, they must have fully recovered from the toxicity and/or complications of the treatment prior to starting study treatment. Patients who require elective major surgical treatment during the study period are not eligible for enrolment.
- •Participants must have recovered to grade ≤1 or baseline level from all AEs resulting from prior treatment.
- •Received radiotherapy within 2 weeks prior to the first dose. For patients who have received radiotherapy prior to 2 weeks before the first dose, all of the following conditions must be met for enrolment: glucocorticosteroids are not required, and radiation pneumonitis, radiation hepatitis, and radiation enteritis are excluded. Patients with palliative radiotherapy to bone lesions more than 7 days from the first dose may be enrolled. Reirradiation of previously treated sites is not permitted.
- •Received an immunomodulatory drug within 2 weeks prior to randomisation.
- •Active Hepatitis B or Hepatitis C.
- •History of severe bleeding tendency or coagulation disorder.
- •Pregnant or lactating female patients.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
研究组 & 干预措施
Treatment
Experimental
1.Not systematically treated: 20 patients with recurrent or metastatic vulvar and vaginal cancers enrolled without systemic treatment (platinum-based doublet chemotherapy) will be treated with cardunolizumab + platinum-based doublet chemotherapy ± bevacizumab.
2.Previous systematic treatment: Twenty patients with recurrent or metastatic vulvar and vaginal cancers previously treated with systemic therapy (platinum-based doublet chemotherapy) will be enrolled as subjects receiving cardunolizumab ± investigator's choice of chemotherapy ± bevacizumab.
干预措施: Cardunolizumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
次要结局
- Overall survival (OS)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Adverse events (AEs)(From first dose of Cardunolizumab through to 90 days after last dose of Cardunolizumab)
研究者
Hanmei Lou
Director
Zhejiang Cancer Hospital
研究点 (1)
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