Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05368207|
Recruitment Status : Enrolling by invitation
First Posted : May 10, 2022
Last Update Posted : May 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Carcinoma, Hypercalcaemic Type Ovarian Cancer||Drug: Pembrolizumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)|
|Actual Study Start Date :||December 6, 2021|
|Estimated Primary Completion Date :||December 6, 2023|
|Estimated Study Completion Date :||December 6, 2023|
Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.
Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.
Other Name: KEYTRUDA
- Progression free survival [ Time Frame: 2 years ]Determined by CT scans
- overall performance status [ Time Frame: 2 years ]Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.
- Objective evidence of response to treatment [ Time Frame: 2 years ]Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment
- Exploratory Endpoint [ Time Frame: 2 Years ]Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368207
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|