A Single-arm Open-label Phase II Trial to Assess the Efficacy and Safety of Pembrolizumab for Unresectable Advanced or Recurrent Ovarian Squamous Cell Carcinoma

Niigata University Medical & Dental Hospital2 个研究点分布在 1 个国家目标入组 21 人2023年5月1日

适应症Ovarian Squamous Cell Carcinoma

干预措施MK-3475 (pembrolizumab)

概览

阶段: 2 期
干预措施: MK-3475 (pembrolizumab)
疾病 / 适应症: Ovarian Squamous Cell Carcinoma
发起方: Niigata University Medical & Dental Hospital
入组人数: 21
试验地点: 2
主要终点: Objective response rate (ORR)
状态: 进行中（未招募）
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a phase II, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of MK-3475 in patients with ovarian squamous cell carcinoma.

详细描述

This study includes female patients 18 years of age or older with advanced or recurrent unresectable squamous cell carcinoma of the ovary. Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles of pembrolizumab with the q3 week dosing.

注册库

clinicaltrials.gov

开始日期

2023年5月1日

结束日期

2028年5月31日

最后更新

2个月前

研究类型

Interventional

研究设计

Single Group

性别

Female

研究者

发起方

Niigata University Medical & Dental Hospital

责任方

Principal Investigator

主要研究者

Kosuke Yoshihara

Professor

Niigata University Medical & Dental Hospital

入排标准

入选标准

•This study includes female patients 18 years of age or older with advanced or recurrent unresectable squamous cell carcinoma of the ovary. No prior approval (e.g., waiver or exemption) is granted for deviations from the study protocol regarding inclusion criteria.
•Inclusion Criteria:
•Participants are eligible to be included in the study only if all of the following criteria apply:
•Female participants who are at least 18 years of age on the day of signing informed consent.
•A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
•Not a woman of childbearing potential (WOCBP) as defined OR
•A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
•The participant is diagnosed with advanced or recurrent unresectable squamous cell carcinoma of ovary which are histologically confirmed.
•The participant provides written informed consent for the trial.
•Have measurable disease based on RECIST 1.

排除标准

•Participants are excluded from the study if any of the following criteria apply:
•A WOCBP who has a positive serum or urine pregnancy test within 72 hours prior to registration .
•TMB-High (TMB score ≥ 10 mut/Mb) by FoundationOne CDx Cancer Genome Profile.
•MSI-High by microsatellite instability test or FoundationOne CDx Cancer Genome Profile.
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
•Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to registration.
•Note: There is no limit to the number of chemotherapy treatments prior to the study. Participants must have recovered from all adverse events (AE) due to previous therapies to ≤Grade 1 or baseline. Participants with alopecia and ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AE Grade ≤2 requiring treatment or hormone replacement may be eligible Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery prior to starting study intervention.
•Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
•Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
•Note: please refer to Section 5.4.2 for information on COVID-19 vaccines

研究组 & 干预措施

MK-3475 (Pembrolizumab)

Treatment with MK-3475 (pembrolizumab) 200 mg.

干预措施: MK-3475 (pembrolizumab)

结局指标

主要结局

Objective response rate (ORR)

时间窗: 2 years

ORR is defined as the proportion of patients with the best overall response to complete response) or partial response (PR) as judged by the blinded independent central review (BICR) according to RECIST 1.1