Clear Cell TumorPhase 2PEACOCCNCT03425565
A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
A Phase 2 study testing Pembrolizumab in people with Clear Cell Tumor and Gynecologic Cancer, run by University College, London at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Clear Cell Tumor, Gynecologic Cancer, Advanced Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 18 Feb 2019to 18 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Western General Hospital
Edinburgh
University College Hospital
London
The Christie Hospital
Manchester
Mount Vernon Hospital
Northwood
Churchill Hospital
Oxford
About this study
Official title: A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
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
- Being tested
- Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
3 weekly cycles of Pembrolizumab administered by IV
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Not described Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (12)
Progression-free Survival
All deaths were included, whether they occurred on study or following treatment discontinuation. For participants who had not died or progressed, progression-free survival were censored at the date of last contact.
Measured: 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 to second disease progression refers to progression in participants re-treated on trial after their first progression. All deaths are included, whether they occur during the re-treatment period or following treatment discontinuation. For participants who have not died or progressed, second progression-free survival were censored at the date of last contact.
Measured: 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
All deaths were included, whether they occurred on study or following treatment discontinuation. For participants who had not died, overall survival was censored at the date of last contact.
Measured: Time from start of treatment to death from any cause.
Objective Response at 12 Weeks
Objective response is defined as a complete or partial response determined by RECIST v1.1. Participants without a tumour assessment at 12 weeks are considered to be non-responders.
Measured: 12 weeks post start of treatment
Best Objective Response Rate
The best objective response rate consists of the best among all objective responses assessed. The analysis of best objective response was performed with all participants over the whole study period (including re-treatment phase).
Measured: 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.
Duration of Response
For patients with an objective response, duration of objective response is defined as the time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 110 days of the last study treatment), whichever occurs first. Participants were censored at the date of last contact.
Measured: Time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 110 days of the last study treatment), whichever occurred first.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Total Score
The questionnaire used is The Functional Assessment of Cancer Therapy - Ovarian (FACT-O), version 4. Questionnaires were completed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and until progression/ end of treatment. The algorithm for core construction is based on that provided by the FACT-O manual using overall score. The higher the score, the better the QoL on a 0-152 scale (sum of physical, social, emotional and functional well-being); a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Physical Well-being (PWB)
The questionnaire used is FACT-O (version 4). Questionnaires were completed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and until progression/ end of treatment. The algorithm for core construction is based on that provided by the FACT-O manual using overall sub-score. The higher the score, the better the QoL on a 0-28 scale; a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Social Well-being (SWB)
The questionnaire used is FACT-O (version 4). Questionnaires were completed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and until progression/ end of treatment. The algorithm for core construction is based on that provided by the FACT-O manual using overall sub-score. The higher the score, the better the QoL on a 0-28 scale; a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Emotional Well-being (EWB)
The questionnaire used is FACT-O (version 4). Questionnaires were completed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and until progression/ end of treatment. The algorithm for core construction is based on that provided by the FACT-O manual using overall sub-score. The higher the score, the better the QoL on a 0-24 scale; a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Functional Well-being (FWB)
The questionnaire used is FACT-O (version 4). Questionnaires were completed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and until progression/ end of treatment. The algorithm for core construction is based on that provided by the FACT-O manual using overall sub-score. The higher the score, the better the QoL on a 0-28 scale; a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: At end of treatment from baseline (before start of treatment), an average of 20 weeks.
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Ovarian Cancer Sub-scale (OCS)
The questionnaire used is FACT-O (version 4). The algorithm for core construction is based on that provided by the FACT-O manual using overall sub-score. The higher the score, the better the QoL on a 0-100 scale (sum of PWB, FWB and OCS); a negative score at end of treatment indicates a decrease in QoL from baseline.
Measured: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start18 Feb 2019
- Primary completion24 Jul 2024
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell TumorStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425565
- Sponsor's protocol ID
- UCL/17/0672
- Acronym
- PEACOCC
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2018
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39913118