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

Advanced Cancer Clinical Trial

— PEACOCC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03425565
• Other study ID #: UCL/17/0672
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 18, 2019
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Clear Cell Tumor
• Gynecologic Cancer

Intervention

Drug:
• Pembrolizumab
3 weekly cycles of Pembrolizumab administered by IV

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival at 12 weeks		12 weeks