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Completed

NCT Number: NCT05368207

Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

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

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Key information

Conditions

Small Cell Carcinoma, Hypercalcaemic Type Adnexal Diseases Carcinoma Carcinoma, Small Cell Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Pembrolizumab

Drug

Pembrolizumab is an antineoplastic agent, monoclonal antibody against PD-L1.

Other names: KEYTRUDA

Primary outcomes

  1. Progression free survival

    Time frame: 2 years

    Determined by CT scans

Secondary outcomes

  1. 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. 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

  3. Exploratory Endpoint

    Time frame: 2 Years

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: Pemb-HT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 10, 2022
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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