Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180733
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-04
Brief Title:
Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer a Phase II Efficacy Study
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAM-II
Brief Summary:
The goal of this clinical trial is to establish the fraction of patients that achieve a major pathological response MPR after 9 cycles of pembrolizumab with the ultimate aim of informing a follow-up randomized trial
Participants will receive 9 cycles of pembrolizumab before their standard of care hysterectomy
Participants will receive 9 cycles of pembrolizumab before their standard of care hysterectomy
Detailed Description:
Objective Based on the success of the pilot feasibility study we propose a phase 2 trial to establish the fraction of patients that achieve a major pathologic response MPR after 9 cycles of pembrolizumab with the ultimate aim of informing a follow-up randomized trial MPR was chosen as primary endpoint to align with ongoing randomized phase 3 ICB trials on neo-adjuvant vs adjuvant treatment in other tumor types eg the NADINA trial in melanoma NCT04949113
Study design Patients will be treated with neo-adjuvant pembrolizumab 200mg IV Q3W for a total of 9 administrations followed by SoC surgery and adjuvant therapy where indicated Tumor responses to pembrolizumab will be assessed by a pathologist primary endpoint using material from the SoC surgery In addition tumor response will be evaluated by MRI secondary endpoint after the second fourth sixth and last cycle of pembrolizumab In case of suspicion of progressive disease the hysterectomy will immediately take place Peripheral blood and tumor samples will be used to explore dynamics of tumor and immune responses during therapy
Follow-up Adverse events will be followed up to 6 months after the final pembrolizumab administration Outside the study protocol patients will be followed-up according SoC guidelines for uterine cancer Patients will be asked to participate in follow-up of disease progression 2-year recurrence-free survival
Study population Primary MMRd UC patients at high-risk of recurrence endometrioid grade 3 or clear cell histology who are intended to be treated with a hysterectomy
Intervention Pembrolizumab 200mg IV Q3W for a total of 9 administrations per patient prior to SoC therapy
Study design Patients will be treated with neo-adjuvant pembrolizumab 200mg IV Q3W for a total of 9 administrations followed by SoC surgery and adjuvant therapy where indicated Tumor responses to pembrolizumab will be assessed by a pathologist primary endpoint using material from the SoC surgery In addition tumor response will be evaluated by MRI secondary endpoint after the second fourth sixth and last cycle of pembrolizumab In case of suspicion of progressive disease the hysterectomy will immediately take place Peripheral blood and tumor samples will be used to explore dynamics of tumor and immune responses during therapy
Follow-up Adverse events will be followed up to 6 months after the final pembrolizumab administration Outside the study protocol patients will be followed-up according SoC guidelines for uterine cancer Patients will be asked to participate in follow-up of disease progression 2-year recurrence-free survival
Study population Primary MMRd UC patients at high-risk of recurrence endometrioid grade 3 or clear cell histology who are intended to be treated with a hysterectomy
Intervention Pembrolizumab 200mg IV Q3W for a total of 9 administrations per patient prior to SoC therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003922-27 | EUDRACT_NUMBER | None | None |