Assessment of the Efficacy and Safety of Pembrolizumab for Ovarian Squamous Cell Carcinoma

NCT05737199 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: JGOG3029
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Squamous Cell Carcinoma

Keywords

Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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

  2 years

Secondary Outcomes (4)

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

• Duration of response (DOR)

  2 years

• safety and tolerability of MK-3475 therapy

  2 years

Other Outcomes (2)

• Exploratory objective: molecular biomarkers for MK-3475 therapy for ovarian squamous cell carcinoma.

  2 years

• Tumor shrinkage efficacy is evaluated by investigator according to RECIST1.1 and iRECIST .

  2 years

Study Arms (1)

MK-3475 (Pembrolizumab)

EXPERIMENTAL

Treatment with MK-3475 (pembrolizumab) 200 mg.

Drug: MK-3475 (pembrolizumab)

Interventions

MK-3475 (pembrolizumab) DRUG

MK-3475 (pembrolizumab) 200mg IV every 3 weeks \[Q3W\] Treated for 2 years (35 cycles), or until PD, unacceptable toxicity, or study withdrawal.

Also known as: Keytruda

MK-3475 (Pembrolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• 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.
• 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.
• Have adequate organ function as defined in the following. Specimens must be collected within 28 days prior to the start of study intervention.
• Absolute neutrophil count (ANC) ≥1500/µL
• Platelets ≥100 000/µL
• Hemoglobin ≥9.0 g/dL
• Creatinine ≤1.5 × upper limit of normal (ULN) OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN of Creatinine

You may not qualify if:

• 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
• 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.
• Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.

Sponsors & Collaborators

• Niigata University Medical & Dental Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Niigata University Medical & Dental Hosptal

Niigata, Niigata, 951-8510, Japan

Location

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Kosuke Yoshihara, Professor

  Niigata University Medical & Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 21, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)