Trials Sponsors Conditions Drugs Pricing

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

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrycollaborator
Niigata University Medical & Dental Hospital
Otherlead

Study Sites (1)

Niigata University Medical & Dental Hosptal

Niigata, Niigata, 951-8510, Japan

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

Actual (reported)

Primary Completion

May 31, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.
+10 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (1)

MK-3475 (Pembrolizumab)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Study Arms (1)

MK-3475 (Pembrolizumab)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations