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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04652076 | GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab | PHASE1 | ACTIVE NOT_RECRUITING | 240 | — | — | Dec 14, 2020 | Jul 30, 2026 | Oct 8, 2024 | 15 | France |
Any pre-definied toxicities graded by using NCI CTCAE Version 5.0 and assessed by the investigator to be possibly, probably, or definitely related to study treatments administration during the safety run in period
Rate of patients with CR or PR as per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Arm A: Standard Chemotherapy alone (Paclitaxel + Carboplatin) | OTHER | Standard Chemotherapy will be adminitred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma |
| Arm B: Experimental double combination [Standard Chemotherapy +NP137] | OTHER | Experimental double combination \[Standard Chemotherapy +NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma |
| Arm C: Experimental double combination [Pembrolizumab +NP137] | OTHER | Experimental double combination \[Pembrolizumab +NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma |
| Arm D: Experimental triple therapeutical combination [Pembrolizumab+ Standard Chemotherapy + NP137] | OTHER | Experimental triple combination \[Pembrolizumab+ Standard Chemotherapy + NP137\] will be administred in 2 independant cohorts: Endometrial carcinoma or Cervix Carcinoma |
| Name | Type | Description |
|---|---|---|
| NP137 | DRUG | Recombinant humanized IgG1 monoclonal antibody against Netrin 1. NP137 will be administred IV, Q3W until disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, pregnancy or SMPC guidance, whichever occurs first. |
| Pembrolizumab | DRUG | Humanised monoclonal anti-programmed cell death-1 (PD-1) antibody will be administred in IV Q3W. A maximum 35 cycles of treatments (approximately 2 years) with pembrolizumab can be administered to patients. |
| Paclitaxel | DRUG | Standard Chemotherapy agent will be administred IV, Q3W, up to 6 cycles of treatment. |
| Carboplatin | DRUG | Standard Chemotherapy agent will be administred IV, Q3W, up to 6 cycles of treatment. |
Inclusion Criteria: * Be women ≥ 18 years at time of inform consent signature. * Patient with histologically confirmed locally advanced / metastatic endometrial carcinoma (Endometrial sarcoma are excluded) or patient with histologically confirmed locally advanced / metastatic cervix adeno- or epide...