Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)

March 12, 2024 updated by: University Health Network, Toronto

Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)

This is a study of pembrolizumab as consolidation therapy for a patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab
Pembrolizumab will be given as an intravenous infusion at 200 mg, every 6 weeks, for 6 cycles.
Drug: Pembrolizumab
Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.
Other Names:
  • KEYTRUDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 2 years
Determined by CT scans
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall performance status
Time Frame: 2 years
Eastern cooperative oncology group (ECOG) score, patient-reported symptoms as well as objective measurements by CT scans.
2 years
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
2 years
Exploratory Endpoint
Time Frame: 2 Years
Exploratory Endpoint will be measured by circulating DNA to monitor minimal residual disease
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Estimated)

November 2, 2024

Study Completion (Estimated)

November 2, 2024

Study Registration Dates

First Submitted

December 10, 2021

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pemb-HT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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