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

NCT03425565 | Unknown Phase 2 DMC

• 1 other identifier: UCL/17/0672
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Clear Cell Tumor; Gynecologic Cancer; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival at 12 weeks

  12 weeks

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

3 weekly cycles of Pembrolizumab administered by IV

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (5)

Western General Hospital

Edinburgh, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

The Christie Hospital

Manchester, United Kingdom

Location

Mount Vernon Hospital

Northwood, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• Kristeleit R, Devlin MJ, Clamp A, Gourley C, Roux R, Hall M, Nirsimloo R, Kounnis V, Sage L, Narayanan P, Herrington CS, Arora R, Farrelly L, Hughes L, Counsell N, Miller RE. Pembrolizumab in Patients With Advanced Clear Cell Gynecological Cancer: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2025 Apr 1;11(4):377-385. doi: 10.1001/jamaoncol.2024.6797.

  PMID: 39913118 DERIVED

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 7, 2018
• Study Start: February 18, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)