Back to resultsPembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)
Primary Purpose
Small Cell Carcinoma, Hypercalcaemic Type, Ovarian Cancer
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Carcinoma, Hypercalcaemic Type
Eligibility Criteria
Inclusion Criteria:
- Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
Exclusion Criteria:
- N/A
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pembrolizumab
Arm Description
Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.
Outcomes
Primary Outcome Measures
Progression free survival
Determined by CT scans
Secondary Outcome Measures
overall performance status
Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.
Objective evidence of response to treatment
Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment
Exploratory Endpoint
Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease
Full Information
NCT ID
NCT05368207
First Posted
December 10, 2021
Last Updated
August 24, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05368207
Brief Title
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient
Acronym
Pemb-HT
Official Title
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Carcinoma, Hypercalcaemic Type, Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA
Intervention Description
Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Determined by CT scans
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall performance status
Description
Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.
Time Frame
2 years
Title
Objective evidence of response to treatment
Description
Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment
Time Frame
2 years
Title
Exploratory Endpoint
Description
Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
Exclusion Criteria:
N/A
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient
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