Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

Not Applicable

Active, not recruiting

• Conditions: Small Cell Carcinoma, Hypercalcaemic Type; Ovarian Cancer
• Interventions: Drug: Pembrolizumab

• 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.

Study Timeline

• Study Start: 2021-12-06
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-11-02
• Study Completion: 2024-11-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab	Pembrolizumab	Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 years	Determined by CT scans

Secondary Outcome Measures

Name	Time	Method
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
overall performance status	2 years	Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada