JPRN-jRCT2031220701
Recruiting
Phase 2
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 - JGOG3029
Yoshihara Kosuke0 sites21 target enrollmentMarch 14, 2023
Conditionsovarian squamous cell carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ovarian squamous cell carcinoma
- Sponsor
- Yoshihara Kosuke
- Enrollment
- 21
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female participants who are at least 18 years of age on the day of signing informed consent.
- •2\. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP)
- •b) 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.
- •3\. The participant is diagnosed with advanced or recurrent unresectable squamous cell carcinoma of ovary which are histologically confirmed.
- •4\. The participant provides written informed consent for the trial.
- •5\. Have measurable disease based on RECIST 1\.1\. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •6\. Archival tumor tissue sample or newly obtained \[core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin\-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- •7\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- •8\. Have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study intervention.
Exclusion Criteria
- •1\. A WOCBP who has a positive serum or urine pregnancy test within 72 hours prior to registration .
- •2\. TMB\-High (TMB score 10 mut/Mb over) by FoundationOne CDx Cancer Genome Profile.
- •3\. MSI\-High by microsatellite instability test or FoundationOne CDx Cancer Genome Profile.
- •4\. 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\).
- •5\. 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 AEs due to previous therapies to less than Grade 1 or baseline. Participants with alopecia and less than Grade 2 neuropathy may be eligible. Participants with endocrine\-related AEs Grade less than 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.
- •6\. 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 (less than 2 weeks of radiotherapy) to non\-CNS disease.
- •7\. 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.
- •8\. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
Outcomes
Primary Outcomes
Not specified
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