Trial of Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer (PROMPT)
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|ClinicalTrials.gov Identifier: NCT03430700|
Recruitment Status : Not yet recruiting
First Posted : February 13, 2018
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients will receive treatment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Maintenance Pembrolizumab Following Weekly Paclitaxel for Platinum-resistant Ovarian, Fallopian Tube or Peritoneal Cancer|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||January 1, 2022|
All patient will receive Pembrolizumab (100 mg/ 4mL) every 3 weeks for a maximum of 2 years. Pembrolizumab 200mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Name: Keytruda
- Progression-Free Survival (PFS) measured from start of study treatment to the date of objective progression (investigator assessed using RECIST 1.1) or date of death from any cause (in the absence of progression). [ Time Frame: 6 months ]Progression free survival (PFS) measure from the first date of trial treatment to 6 months of treatment.
- Overall survival measured from start of study treatment to the date of death from any cause [ Time Frame: 4 years ]Overall survival (death from any cause) measured from the start of study treatment
- Disease response [ Time Frame: 4 years ]Disease response investigator assessed by RECIST 1.1, from when a patient starts trial treatment until patients starts new anti-cancer treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430700
|Contact: PROMPT Trial Coordinator||+44 (0)email@example.com|
|Study Chair:||UCL Cancer Trials Centre||UCL|