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A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer (PEACOCC)

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: NCT03425565
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
University College, London

Study Description
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Brief Summary:
PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.

Condition or disease Intervention/treatment Phase
Clear Cell Tumor Gynecologic Cancer Advanced Cancer Drug: Pembrolizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pembrolizumab Drug: Pembrolizumab
3 weekly cycles of Pembrolizumab administered by IV


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival at 12 weeks [ Time Frame: 12 weeks ]

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

Main Inclusion Criteria:

  1. Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
  2. Have measurable disease based on RECIST 1.1.
  3. Evidence of radiological disease progression.
  4. Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
  5. ECOG Performance Status 0 or 1.
  6. Patient has a life expectancy of at least 3 months from consent.
  7. Received ≥ 1 line of prior chemotherapy .

Main Exclusion Criteria:

  1. Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses > 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  2. Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV).
  3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
  4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose >10mg predisolone daily or equivalent) or immunosuppressive drugs).
  5. Has known history or evidence of active, non-infectious pneumonitis.
  6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  7. Has received a live vaccine within 30 days prior to the planned start of trial treatment.
Contacts and Locations
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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): NCT03425565


Locations
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United Kingdom
Western General Hospital
Edinburgh, United Kingdom
University College Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Mount Vernon Hospital
Northwood, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
University College, London
More Information
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03425565    
Other Study ID Numbers: UCL/17/0672
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: November 3, 2022
Last Verified: November 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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Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents