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

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

Tracking Information

• First Submitted Date: February 1, 2018
• First Posted Date: February 7, 2018
• Last Update Posted Date: November 3, 2022
• Actual Study Start Date: February 18, 2019
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 6, 2018): Progression Free Survival at 12 weeks [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
• Official Title: A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Clear Cell Tumor
• Gynecologic Cancer
• Advanced Cancer

Intervention

Drug: Pembrolizumab

3 weekly cycles of Pembrolizumab administered by IV

Study Arms

Experimental: Pembrolizumab

Intervention: Drug: Pembrolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 6, 2018): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03425565
• Other Study ID Numbers: UCL/17/0672
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University College, London
• Original Responsible Party: Same as current
• Current Study Sponsor: University College, London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University College, London
• Verification Date: November 2022