Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04014530 | Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study | PHASE1 | RECRUITING | 47 | — | — | Aug 1, 2019 | Aug 1, 2023 | Feb 1, 2023 | 1 | Netherlands |
To characterize toxicities and side effects of Ataluren when combined with pembrolizumab in patients with pMMR CRC, dMMR mCRC and dMMR EC. Recorded on Adverse Events form and ranking adverse event severity according to the NCI Common Terminology Criteria for Adverse Events v3.0
Measured by immune-related response criteria
| Arm | Type | Description |
|---|---|---|
| Phase I dMMR and pMMR | EXPERIMENTAL | 2-4 groups of 3 patients treatment with 200mg i.v. Pembrolizumab q3w and dose escalation of Ataluren in order to determine the Ataluren MTD. These patients can either be pMMR/dMMR CRC and dMMR EC patients. |
| Phase II dMMR | EXPERIMENTAL | Mismatch repair deficient CRC or EC patients treated with 200mg i.v. pembrolizumab q3w and Ataluren at MTD. |
| Phase II pMMR | EXPERIMENTAL | Mismatch repair proficient CRC patients treated with 200mg i.v. pembrolizumab q3w and Ataluren at MTD. |
| Name | Type | Description |
|---|---|---|
| Ataluren + Pembrolizumab | DRUG | Ataluren and Pembrolizumab combination therapy |
In order to be eligible for participation in this trial, the subject must: * Have at least one lesion with measurable disease as defined by 10mm in longest diameter for a soft tissue lesions or 15mm in short axis for a lymph node by RECIST 1.1 and irRC criteria for response assessment. * Have recei...