Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NP137 · 1 trial · 2 indications
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...
NP137 is an investigational small molecule being studied for the treatment of endometrial carcinoma. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with chemotherapy and/or pembrolizumab for gynecological cancers, including endometrial and cervix carcinoma.
NP137 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gynecological cancers, specifically endometrial carcinoma.
NP137 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is currently being studied in an active clinical trial that is not yet recruiting participants.
NP137 is being studied in a Phase 1 clinical trial with the identifier NCT04652076. This trial is titled 'GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab' and is active but not recruiting. The trial is enrolling female patients aged 18 years and older in France.
Yes, the clinical trial for NP137 is randomized and controlled, but it is not double-blind. The trial includes a control group and uses biomarker selection. The study is designed to evaluate the drug in combination with other therapies for gynecological cancers.