Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551521
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-07-24
Brief Title:
CRAFT The NCT-PMO-1602 Phase II Trial
Sponsor:
German Cancer Research Center
Organization:
German Cancer Research Center
Study Overview
Official Title:
Continuous ReAssessment With Flexible ExTension in Rare Malignancies - CRAFT The NCT-PMO-1602 Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Whole-genome and transcriptome sequencing of patients with advanced solid tumors enrolled in the NCTDKTK MASTER Molecularly Aided Stratification for Tumor Eradication Research program revealed genetic alterations in a substantial proportion of patients including i alterations that lead to aberrant activation of BRAF ERBB2 ALK and the PI3K-AKT and MAPK pathways and ii changes that predict sensitivity to immune checkpoint inhibition such as high tumor mutational burden and specific alterations of the PD-L1 locus
Within this seven-arm basket phase II clinical trial we aim to investigate the efficacy of targeted-therapy plus immune checkpoint inhibition in patients with advanced tumors exhibiting one of the following genetic alterations detected within the NCTDKTK MASTER study i BRAF V600EK ii ERBB2 amplification andor overexpression or activating ERBB2 mutation iii ALK rearrangement or activating ALK mutation iv activating mutations or amplification of AKT loss of PTEN v activating PIK3CA mutations vi abberations predicting increased RAF-MEK-ERK pathway activity vii patients with high tumor mutational burden andor specific alteration predicting sensitivity to PD-1PD-L1 inhibition are eligible within this study for immune checkpoint inhibition Recruitment of adequate patient numbers into these well-defined molecular subgroups is achieved in a multicenter approach including NCT Heidelberg and NCT Dresden as well as DKTK partner sites Eligible patients will be identified by in-depth molecular characterization of tumors within the NCTDKTK MASTER program All study arms are based on similar biometrical assumptions and sample size as well as power calculations are based on Simons optimal two-stage design for each study arm separately The overall aim is to reduce the cumulative hazard of progression-free survival observed within the study PFS2 compared to the cumulative hazard of the progression-free time before inclusion into the study PFS1 using a paired log-rank test The sample size of the entire trial varies according to the performance of the individual study arms ranging between 98 and 175 patients
Within this seven-arm basket phase II clinical trial we aim to investigate the efficacy of targeted-therapy plus immune checkpoint inhibition in patients with advanced tumors exhibiting one of the following genetic alterations detected within the NCTDKTK MASTER study i BRAF V600EK ii ERBB2 amplification andor overexpression or activating ERBB2 mutation iii ALK rearrangement or activating ALK mutation iv activating mutations or amplification of AKT loss of PTEN v activating PIK3CA mutations vi abberations predicting increased RAF-MEK-ERK pathway activity vii patients with high tumor mutational burden andor specific alteration predicting sensitivity to PD-1PD-L1 inhibition are eligible within this study for immune checkpoint inhibition Recruitment of adequate patient numbers into these well-defined molecular subgroups is achieved in a multicenter approach including NCT Heidelberg and NCT Dresden as well as DKTK partner sites Eligible patients will be identified by in-depth molecular characterization of tumors within the NCTDKTK MASTER program All study arms are based on similar biometrical assumptions and sample size as well as power calculations are based on Simons optimal two-stage design for each study arm separately The overall aim is to reduce the cumulative hazard of progression-free survival observed within the study PFS2 compared to the cumulative hazard of the progression-free time before inclusion into the study PFS1 using a paired log-rank test The sample size of the entire trial varies according to the performance of the individual study arms ranging between 98 and 175 patients
Detailed Description:
None
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