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Completed

NCT Number: NCT03425565

A 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.

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Key information

Conditions

Clear Cell Tumor Advanced Cancer Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Western General Hospital, Edinburgh, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pembrolizumab

Drug

3 weekly cycles of Pembrolizumab administered by IV

Primary outcomes

  1. Progression Free Survival at 12 Weeks

    Time frame: 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.

Secondary outcomes

  1. Progression-free Survival

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

    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.

  2. Time to Second Disease Progression (Re-treatment Period)

    Time frame: 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.

    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.

  3. Overall Survival

    Time frame: Time from start of treatment to death from any cause.

    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.

  4. Objective Response at 12 Weeks

    Time frame: 12 weeks post start of treatment

    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.

  5. Best Objective Response Rate

    Time frame: 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.

    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).

  6. Duration of Response

    Time frame: 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.

    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.

  7. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Total Score

    Time frame: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

  8. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Physical Well-being (PWB)

    Time frame: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

  9. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Social Well-being (SWB)

    Time frame: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

  10. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Emotional Well-being (EWB)

    Time frame: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

  11. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Functional Well-being (FWB)

    Time frame: At end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

  12. Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Ovarian Cancer Sub-scale (OCS)

    Time frame: Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.

    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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: PEACOCC

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Feb 7, 2018
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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