Ignite Creation Date:
2024-05-06 @ 10:28 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03274804
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2017-08-14
Brief Title:
Combined PD-1 and CCR5 Inhibition for the Treatment of Refractory Microsatellite Stable mCRC
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
A Phase I Trial of Combined PD-1 Inhibition Pembrolizumab and CCR5 Inhibition Maraviroc for the Treatment of Refractory Microsatellite Stable MSS Metastatic Colorectal Cancer mCRC
Status:
COMPLETED
Status Verified Date:
2022-05
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:
PICCASSO
Brief Summary:
This is a monocentric single arm prospective open-label trial of a combination treatment consisting of pembrolizumab and maraviroc in previously treated subjects who have refractory microsatellite stable MSS metastatic colorectal cancer mCRC
Detailed Description:
Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle d1 qd22 together with maraviroc administered perorally on day 1 to 21 of each cycle d1-21 qd22
Treatment with pembrolizumab maraviroc combination will continue until progressive disease PD unacceptable adverse events AEs intercurrent illness that prevents further administration of treatment investigators decision to withdraw the subject subject withdraws consent pregnancy of the subject noncompliance with trial treatment or procedure requirements administrative reasons requiring cessation of treatment or completion of treatment per protocol
Subjects with a treatment response or stable disease after completion of the first treatment phase of eight cycles core treatment period will be offered at the discretion of the investigator participation in a maintenance phase consisting of up to 24 additional treatment cycles of pembrolizumab monotherapy total treatment duration up to 24 months
Subjects who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD initiating a non-study cancer treatment withdrawing consent or becoming lost to follow-up All subjects will be followed for overall survival OS until death withdrawal of consent loss to follow-up or the end of the study
After the end of treatment each subject will be followed for 30 days for AE monitoring Serious adverse events SAEs and AEs of special interest AESIs will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Treatment with pembrolizumab maraviroc combination will continue until progressive disease PD unacceptable adverse events AEs intercurrent illness that prevents further administration of treatment investigators decision to withdraw the subject subject withdraws consent pregnancy of the subject noncompliance with trial treatment or procedure requirements administrative reasons requiring cessation of treatment or completion of treatment per protocol
Subjects with a treatment response or stable disease after completion of the first treatment phase of eight cycles core treatment period will be offered at the discretion of the investigator participation in a maintenance phase consisting of up to 24 additional treatment cycles of pembrolizumab monotherapy total treatment duration up to 24 months
Subjects who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD initiating a non-study cancer treatment withdrawing consent or becoming lost to follow-up All subjects will be followed for overall survival OS until death withdrawal of consent loss to follow-up or the end of the study
After the end of treatment each subject will be followed for 30 days for AE monitoring Serious adverse events SAEs and AEs of special interest AESIs will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None