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Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

Not Applicable
Active, not recruiting
Conditions
Small Cell Carcinoma, Hypercalcaemic Type
Ovarian Cancer
Interventions
Registration Number
NCT05368207
Lead Sponsor
University Health Network, Toronto
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1
Inclusion Criteria
  • Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
Exclusion Criteria
  • N/A

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PembrolizumabPembrolizumabPembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.
Primary Outcome Measures
NameTimeMethod
Progression free survival2 years

Determined by CT scans

Secondary Outcome Measures
NameTimeMethod
overall performance status2 years

Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.

Exploratory Endpoint2 Years

Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease

Objective evidence of response to treatment2 years

Recorded with CA-125 every 6 weeks and CT scans after every 2 cycles of treatment

Trial Locations

Locations (1)

Princess Margaret Cancer Centre

🇨🇦

Toronto, Ontario, Canada

Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada

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