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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05368207
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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 Design

Study Type:
Interventional
Anticipated 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.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 :
Dec 6, 2021
Anticipated Primary Completion Date :
Dec 6, 2023
Anticipated Study Completion Date :
Dec 6, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [2 years]

      Determined by CT scans

    Secondary Outcome Measures

    1. overall performance status [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 [2 years]

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

    3. Exploratory Endpoint [2 Years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with small cell carcinoma of the ovary, hypercalcemic type (SCCOHT)
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT05368207
    Other Study ID Numbers:
    • Pemb-HT
    First Posted:
    May 10, 2022
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Ovarian Neoplasms
    Carcinoma, Small Cell
    Small Cell Lung Carcinoma
    Carcinoma, Ovarian Epithelial
    Pembrolizumab

    Study Results

    No Results Posted as of May 10, 2022