Ovarian Cancer, Small Cell Carcinoma, Hypercalcaemic Type
Conditions
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.
Interventions
DRUGPembrolizumab
Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2 years | Determined by CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall performance status | 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 | 2 years | Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment |
| Exploratory Endpoint | 2 Years | Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease |
Countries
Canada
Outcome results
None listed