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

NCT03425565 | Completed Phase 2 Results 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

  The proportion of progression-free participants is defined as the number of participants alive with complete or partial response or stable disease maintained at 12 weeks (as assessed by the site radiologist and/or investigator, using RECIST v1.1) divided by the number of participants in the analysis population. Only participants with tumour assessment at or beyond 12 weeks were considered progression-free. All eligible participants who received at least one cycle of pembrolizumab were included in the analysis population. Any patient found to be ineligible will be excluded and replaced.

  12 weeks

Secondary Outcomes (12)

• Progression-free Survival

  Time from start of trial treatment to progression or death from any cause (whichever came first).

• Time to Second Disease Progression (Re-treatment Period)

  Time from diagnosis of first progression during or after their initial pembrolizumab therapy to second progression or death from any cause (whichever came first), during or after their retreatment pembrolizumab.

• Overall Survival

  Time from start of treatment to death from any cause.

• Objective Response at 12 Weeks

  12 weeks post start of treatment

• Best Objective Response Rate

  Time from start of treatment until last tumour assessment. Tumour imaging was performed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and follow-up; on average the last response assessment was at 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

Limitations and Caveats

The main limitations of our study are the single-arm design and moderate sample size of the trial.

Results Point of Contact

• Title: Trial Research Team (Sponsor)
• Organization: University College London

ctc.peacocc@ucl.ac.uk

0207 679 9284

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: July 24, 2024
• Study Completion: September 18, 2026
• Last Updated: September 22, 2026
• Results First Posted: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)