Metastatic colorectal cancer
Conditions
Brief summary
To assess the objective response rate of pembrolizumab in metastatic MMR proficient, extended RAS mutated CRC patients who have failed standard therapies, with MGMT-negative tumors treated with TMZ, given with the intent of increasing the mutational load of their tumors (cohort P).
Detailed description
To assess the objective response rate in MMR deficient patients (cohort D) identified during the MMR screening., To assess the Progression Free Survival (PFS) and Overall Survival (OS) both P and D cohorts patients., To assess the safety and tolerability of pembrolizumab after TMZ-priming therapy (cohort P)., To assess the safety and tolerability of pembrolizumab (cohort D).
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGTEMOZOLOMIDE
Sponsors
Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the objective response rate of pembrolizumab in metastatic MMR proficient, extended RAS mutated CRC patients who have failed standard therapies, with MGMT-negative tumors treated with TMZ, given with the intent of increasing the mutational load of their tumors (cohort P). | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the objective response rate in MMR deficient patients (cohort D) identified during the MMR screening., To assess the Progression Free Survival (PFS) and Overall Survival (OS) both P and D cohorts patients., To assess the safety and tolerability of pembrolizumab after TMZ-priming therapy (cohort P)., To assess the safety and tolerability of pembrolizumab (cohort D). | — |
Countries
Italy
Outcome results
None listed