ClinicalTrials.gg
CompletedNCT03425565PEACOCCUpdated Sep 22, 2026Results posted

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

A Phase 2 interventional study of Pembrolizumab in Clear Cell Tumor, Gynecologic Cancer and Advanced Cancer, sponsored by University College, London. Completed at 5 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by University College, London · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Clear Cell Tumor
  • Gynecologic Cancer
  • Advanced Cancer
03

In context

Lead sponsor

University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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 based on 1.1.
  3. Evidence of radiological disease progression.
  4. Patient is willing to provide tissue from a newly obtained core or excisional of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
  5. Performance Status 0 or 1.
  6. Patient has a of at least 3 months from consent.
  7. Received ≥ 1 .

Main Exclusion Criteria:

  1. Has a known diagnosis of immunodeficiency or is receiving systemic therapy at doses > 10mg prednisolone daily or equivalent or any other form of therapy within 7 days prior to the first dose of trial treatment.
  2. Has a known history of active TB (Bacillus Tuberculosis), (e.g., HBsAg reactive), or a known history of (HIV).
  3. Has symptomatic central nervous system (CNS) and/or carcinomatous meningitis.
  4. Has active 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-L1, or anti-PD-L2 agent.
  7. Has received a within 30 days prior to the planned start of trial treatment.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Pembrolizumab

    Drug: Pembrolizumab

Interventions

  • 3 weekly cycles of Pembrolizumab administered by IV

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

07

Results

Posted Sep 22, 2026
Limitations and caveats
The main limitations of our study are the single-arm design and moderate sample size of the trial.

Participant flow

Potential participants were identified through routine clinics/multi disciplinary team meetings at the trial NHS Hospital research locations, or referral from external NHS Trust Consultant Oncologists. Patients were clinical screened for the trial and those who consented and were confirmed eligible by site investigator were registered by the Sponsor to enter the trial and start receiving trial treatment, pembrolizumab. The trial started recruiting patient

Participant flow — Overall Study
MilestonePembrolizumab
Started48
Completed48
Not completed0

Outcome measures

PrimaryProgression 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
Reported as:
Number · % of participants
Progression Free Survival at 12 Weeks
% of participantsPembrolizumab
Progression Free Survival at 12 Weeks42 (28 to 57)
SecondaryProgression-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).
Reported as:
Median · Months
Progression-free Survival
MonthsPembrolizumab
Progression-free Survival2.7 (1.3 to 5.4)
SecondaryTime 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.
Reported as:
Number · Months
Time to Second Disease Progression (Re-treatment Period)
MonthsPembrolizumab
Time to Second Disease Progression (Re-treatment Period)7.1
SecondaryOverall 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.
Reported as:
Median · Months
Overall Survival
MonthsPembrolizumab
Overall Survival14.8 (6.7 to 28.2)
SecondaryObjective 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
Reported as:
Number · % of participants
Objective Response at 12 Weeks
% of participantsPembrolizumab
Objective Response at 12 Weeks21 (10 to 35)
SecondaryBest 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.
Reported as:
Number · % of participants
Best Objective Response Rate
% of participantsPembrolizumab
Best Objective Response Rate25 (14 to 40)
SecondaryDuration 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.
Reported as:
Median · Months
Duration of Response
MonthsPembrolizumab
Duration of Response13.1 (4.2 to 26.5)
SecondaryQuality 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.

Time frame:
Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O total score
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Total Score
FACT-O total scorePembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Total Score-6.7 ± 20.88
SecondaryQuality 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.

Time frame:
Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O score (PWB)
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Physical Well-being (PWB)
FACT-O score (PWB)Pembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Physical Well-being (PWB)-1.3 ± 5.40
SecondaryQuality 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.

Time frame:
Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O score (SWB)
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Social Well-being (SWB)
FACT-O score (SWB)Pembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Social Well-being (SWB)-1.3 ± 3.43
SecondaryQuality 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.

Time frame:
Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O score (EWB)
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Emotional Well-being (EWB)
FACT-O score (EWB)Pembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Emotional Well-being (EWB)-0.3 ± 4.29
SecondaryQuality 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.

Time frame:
At end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O score (FWB)
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Functional Well-being (FWB)
FACT-O score (FWB)Pembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Functional Well-being (FWB)-1.8 ± 6.72
SecondaryQuality 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.

Time frame:
Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.
Reported as:
Mean · FACT-O score (OCS)
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Ovarian Cancer Sub-scale (OCS)
FACT-O score (OCS)Pembrolizumab
Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Ovarian Cancer Sub-scale (OCS)-2.0 ± 7.87

Adverse events

Collected over All adverse events that occurred between informed consent and 30 days (or 110 for Adverse Events of Special Interest) post last trial treatment administration were collected, up to 2 years plus 30 days. Serious Adverse Events that occurred between informed consent and 110 days post last trial treatment administration (or after this date if the site investigator assessed the event as related to a trial treatment) were collected, up to 2 years plus 110 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pembrolizumab40/48 (83.3%)18/48 (37.5%)48/48 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventPembrolizumab
FeverGeneral disorders3/48
Abdominal painGastrointestinal disorders2/48
Acute kidney injuryRenal and urinary disorders2/48
Alanine aminotransferase increasedInvestigations2/48
AscitesGastrointestinal disorders2/48
Aspartate aminotransferase increasedInvestigations2/48
DiarrhoeaGastrointestinal disorders2/48
HypercalcaemiaMetabolism and nutrition disorders2/48
HyperthyroidismEndocrine disorders2/48
Lung InfectionInfections and infestations2/48
Most frequent other events
Showing 10 of 149
Most frequent other events
EventPembrolizumab
fatigueGeneral disorders25/48
nauseaGastrointestinal disorders24/48
anorexiaMetabolism and nutrition disorders18/48
abdominal painGastrointestinal disorders16/48
constipationGastrointestinal disorders16/48
diarrheaGastrointestinal disorders16/48
hypertensionVascular disorders15/48
painGeneral disorders14/48
vomitingGastrointestinal disorders14/48
back painMusculoskeletal and connective tissue disorders12/48

Baseline characteristics

All trial participants who were registered and received at least one cycle of trial treatment were included in analysis.

Age, Continuous
Age, Continuous(years)Pembrolizumab
Median58.5 (32 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Pembrolizumab
Female48
Male0
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Pembrolizumab
08

Study locations

5 sites
  • 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
    Oxford, United Kingdom
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2019 to primary completion in Jul 2024, 65 months.

Results were first posted in Sep 2026, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2018
First posted
Feb 7, 2018
StartActual
Feb 18, 2019
Primary completionActual
Jul 24, 2024
CompletionActual
Sep 18, 2026
Results first posted
Sep 22, 2026
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03425565
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Feb 18, 2019
Primary completion
Jul 24, 2024
Completion
Sep 18, 2026
Results posted
Sep 22, 2026
Last update
Sep 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Pembrolizumab

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