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Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

Phase II Trial of Maintenance Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

NCT03430700•University College, London

View on ClinicalTrials.gov

Summary

The overall aim of the study is to demonstrate a clinically meaningful extension of progression free survival using maintenance pembrolizumab. The aim of the translational research is to study the immune microenvironment before and during pembrolizumab therapy.

Detailed Description

This study aims to investigate the effect of maintenance pembrolizumab in patients who have undergone treatment with weekly paclitaxel for platinum-resistant recurrent ovarian cancer and have either responded or have not progressed after a minimum of 4 cycles of treatment. In this study patients will receive 3 weekly pembrolizumab until progression and the investigators will monitor the immune microenvironment by tumour biopsy and blood sampling before starting pembrolizumab and again before cycle 4 of treatment. The clinical endpoint will be to demonstrate a worthwhile improvement in the 6 month median PFS and to study possible predictive markers or response to pembrolizumab. This is a non-randomised phase II study, and the population may be different from those who received paclitaxel and bevacizumab.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must have a diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
•2. Be willing and able to provide written informed consent for the trial, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
•3. Be \>=18 years of age on day of signing informed consent
•4. Patients should be treated with a minimum of 4 cycles of weekly paclitaxel for recurrent disease. \[Non-platinum-based therapy given for CT/MR documented recurrence where further platinum therapy considered unsuitable\]
•5. Patients can have had up to 3 prior lines of platinum-based chemotherapy for ovarian cancer before starting weekly paclitaxel
•6. Patients must have achieved at least stable disease or response following a minimum of four cycles of weekly paclitaxel (measured by CT/MR)
•7. Trial treatment with pembrolizumab must start within 8 weeks after last paclitaxel dose
•8. Availability of archival tissue
•9. Fresh tumour biopsy should be taken at baseline if this is judged by radiological assessment to be technically feasible. If a biopsy is taken at baseline, then a second biopsy should be taken, if feasible before the start of cycle 4
•10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
+4 more criteria

Exclusion Criteria

•1. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)
•2. Has a diagnosis of low grade or mucinous ovarian cancer
•3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC). Use of inhaled steroids is permitted.
•4. Has a known history of active TB (Bacillus Tuberculosis)
•5. Has known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected)\*
•6. Has a known history of Human Immunodeficiency Virus (HIV)
•7. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to registration.
•Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible
•8. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (a maximum of 2 weeks radiotherapy is allowed) to non-CNS disease
•9. Patients with concurrent or previous malignancy within the last 5 years (except Stage I grade 1 endometrial cancer; in situ cervical cancer; DCIS of the breast) that could compromise assessment of the primary or secondary endpoints of the trial
+11 more criteria

Locations (4)

Barts

London, United Kingdom

Imperial

London, United Kingdom

UCLH

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Key Dates

Start Date

May 16, 2019

Primary Completion Date

March 17, 2025

Completion Date

March 17, 2025

Last Updated

January 30, 2023

Enrollment

ESTIMATED participants

Conditions

Ovarian CancerFallopian Tube CancerPeritoneal Cancer

Interventions

Pembrolizumab

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer

Inclusion Criteria

Exclusion Criteria

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