A clinical study testing the effectiveness of an immunotherapy cancer drug called pembrolizumab, in patients who have progressed with gynaecological cancer, called clear cell cancer.

Phase 1

• Conditions: Advanced Gynaecological Clear Cell Cancer; MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10009252Term: Clear cell endometrial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10046885Term: Vaginal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10047741Term: Vulval cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004168-36-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

1. Histological diagnosis of advanced gynaecological cancer including ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
2. Be willing and able to provide written informed consent/assent for the trial.
3. Age =18 years.
4. Patient must have at least one measurable lesion according to RECIST v1.1 in addition to a separate biopsiable lesion. Measurable lesions should be outside any prior radiation field unless progression has occurred at that site.
5. Have measurable disease according to RECIST v1.1.
6. Evidence of radiological disease progression.
7. Patient is willing to provide archival tissue.
8. ECOG Performance Status 0 or 1.
9. Patient has a life expectancy of at least 4 months from consent.
10. Received = 1 line of prior chemotherapy.
11. Demonstrate adequate organ function.
12. For patients of childbearing potential, negative urine or serum pregnancy test prior to receiving the first dose of study medication.
13. Patients of childbearing potential must be willing to use a highly effective method of contraception for the study duration required.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Patient is currently participating in and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
2. Prior anti-cancer monoclonal antibody (mAb), chemotherapy or targeted small molecule therapy within 4 weeks prior to study treatment Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
3. Radiation therapy within 2 weeks prior to starting study treatment.
4. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent.
5. 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.
6. Has a known history of active bacillus tuberculosis (TB).
7. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] detected) infection.
8. Known history of Human Immunodeficiency Virus (HIV) (HIV type 1/2 antibodies).
9. Known hypersensitivity to pembrolizumab or any of its excipients.
10. Known additional malignancy that is progressing or requires active treatment. If there is a history of a second malignancy and there is doubt regarding the aetiology of progressive disease, then a biopsy is required to determine the diagnosis.
11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
12. 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).
13. Corrected serum calcium of grade 1 hypercaelcemia (>2.9 mmol/L) despite maximal antihypercalcaemic therapy.
14. Has a known history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
15. Newly diagnosed venous thromboembolic event (eg pulmonary embolism, deep vein thrombosis DVT), unless patient has received at least 14 days of therapeutic dose anticoagulation for a new thromboembolic event and is suitable for continued therapeutic anticoagulation during trial participation.
16. History of arterial thrombosis (excluding the pulmonary artery), within 12 months prior to registration (if beyond 12 months prior to registration, patient may be included providing they have fully recovered clinically).
17. Active infection requiring systemic therapy (for example antibiotics, antivirals, antifungals).
18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
20. Pregnant or breastfeeding.
21. Has received a live vaccine within 30 days prior to the planned start of trial treatment.
22. Has been hospitalised for bowel obstruction within 4 weeks prior to registration.
23. Current abdominal/pelvic fistulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified