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

Sponsor
University College, London (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03425565
Collaborator
(none)
48
Enrollment
5
Locations
1
Arm
66.4
Anticipated Duration (Months)
9.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
Actual Study Start Date :
Feb 18, 2019
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pembrolizumab

Drug: Pembrolizumab
3 weekly cycles of Pembrolizumab administered by IV

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival at 12 weeks [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western General Hospital Edinburgh United Kingdom
2 University College Hospital London United Kingdom
3 The Christie Hospital Manchester United Kingdom
4 Mount Vernon Hospital Northwood United Kingdom
5 Churchill Hospital Oxford United Kingdom

Sponsors and Collaborators

  • University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT03425565
Other Study ID Numbers:
  • UCL/17/0672
First Posted:
Feb 7, 2018
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pembrolizumab

Study Results

No Results Posted as of Oct 25, 2021