Status:
UNKNOWN
A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
Lead Sponsor:
University College, London
Conditions:
Clear Cell Tumor
Gynecologic Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 gynaecologica...
Eligibility Criteria
Inclusion
- Main
- Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
- Have measurable disease based on RECIST 1.1.
- Evidence of radiological disease progression.
- 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.
- ECOG Performance Status 0 or 1.
- Patient has a life expectancy of at least 3 months from consent.
- Received ≥ 1 line of prior chemotherapy .
- Main
Exclusion
- 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.
- 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).
- Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 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).
- Has known history or evidence of active, non-infectious pneumonitis.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has received a live vaccine within 30 days prior to the planned start of trial treatment.
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03425565
Start Date
February 18 2019
End Date
September 1 2024
Last Update
April 12 2024
Active Locations (5)
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1
Western General Hospital
Edinburgh, United Kingdom
2
University College Hospital
London, United Kingdom
3
The Christie Hospital
Manchester, United Kingdom
4
Mount Vernon Hospital
Northwood, United Kingdom