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NCT05368207 Clinical Trial

Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

Ovarian Cancer Clinical Trial

— Pemb-HT  

Official title:
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05368207
Other study ID # Pemb-HT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 6, 2021
Est. completion date November 2, 2024

Study information
Verified date March 2024
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).

Description:

It is an open-label single patient Clinical Trial to be conducted at Princess Margaret Cancer Centre for a patient with Small Cell Carcinoma of Ovary - Hypercalcemic Type (SCCOHT) who has rare and aggressive malignancy with no current consensus on treatment approach and surveillance.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1
Est. completion date November 2, 2024
Est. primary completion date November 2, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pembrolizumab
Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.

Locations
Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival Determined by CT scans 2 years
Secondary overall performance status Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans. 2 years
Secondary Objective evidence of response to treatment Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment 2 years
Secondary Exploratory Endpoint Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease 2 Years
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