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

University College, London48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clear Cell Tumor Gynecologic Cancer Advanced Cancer

Interventions

PembrolizumabDRUG

3 weekly cycles of Pembrolizumab administered by IV

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Western General Hospital

Edinburgh, United Kingdom

University College Hospital

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

Mount Vernon Hospital

Northwood, United Kingdom

Churchill Hospital

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

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.

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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Oxford, United Kingdom

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.

Time frame: 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).

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.

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.

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.

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.