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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05368207
Recruitment Status : Enrolling by invitation
First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Small Cell Carcinoma, Hypercalcaemic Type Ovarian Cancer Drug: Pembrolizumab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient (Pemb-HT)
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : December 6, 2023
Estimated Study Completion Date : December 6, 2023


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 Name: KEYTRUDA




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
    Determined by CT scans


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05368207


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05368207    
Other Study ID Numbers: Pemb-HT
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents