NCT05368207

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

December 10, 2021

Last Update Submit

March 12, 2024

Conditions

Small Cell Carcinoma, Hypercalcaemic TypeOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    Determined by CT scans

    2 years

Secondary Outcomes (3)

  • overall performance status

    2 years

  • Objective evidence of response to treatment

    2 years

  • Exploratory Endpoint

    2 Years

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

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

Drug: Pembrolizumab

Interventions

PembrolizumabDRUG

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

Also known as: KEYTRUDA
Pembrolizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Small CellOvarian Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2021

First Posted

May 10, 2022

Study Start

December 6, 2021

Primary Completion

November 2, 2024

Study Completion

November 2, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)