A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer (PEACOCC)
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|ClinicalTrials.gov Identifier: NCT03425565|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : November 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Tumor Gynecologic Cancer Advanced Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
3 weekly cycles of Pembrolizumab administered by IV
- Progression Free Survival at 12 weeks [ Time Frame: 12 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Main Inclusion Criteria:
- 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 Criteria:
- 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.
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
|Western General Hospital|
|Edinburgh, United Kingdom|
|University College Hospital|
|London, United Kingdom|
|The Christie Hospital|
|Manchester, United Kingdom|
|Mount Vernon Hospital|
|Northwood, United Kingdom|
|Oxford, United Kingdom|
|Responsible Party:||University College, London|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Antineoplastic Agents, Immunological