GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembroliz… (NCT04652076) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab
France240 participantsStarted 2020-12-14
Plain-language summary
The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 epidermoid- carcinoma.
* Previously treated by at least one line of platinum based chemotherapy, but no more than 3 lines of chemotherapies whatever the nature. If the previous based platinum chemotherapy was given as neoadjuvant or adjuvant chemotherapy for a local disease (stage I or II), inclusion must be performed no more than one year after the end of this chemotherapy, except if an advanced or metastatic relapse has been documented and treated by a systemic anti-cancer agent during this time interval.
In all cases, a minimal wash-out period of 6 months after completion of last chemotherapy with \[platinum + paclitaxel\] is required prior to entering the study.
Platinum chemotherapy concomitant to RT can not be considered as a line of previous platinum based chemotherapy.
* For endometrium carcinoma: mutational profile (MSI/MSS status) available before randomization (see St Paul de Vence 2019- ARCAGY - GINECO Group recommendation).
* Documented disease progression as per RECIST V1.1 after prior systemic chemotherapy regimen and presence of at least one lesion evaluable for response according to RECIST 1.1.
* Have provided a representative archival tumor sample in formalin-fixed …
What they're measuring
1
DLT occurrence
Timeframe: Safety run in Period: At the end of Cycle 2 (each cycle is 21 days) for the first 6 to 12 patients per arm
2
Overall response Rate (ORR)
Timeframe: At 3 months of treatement and then every 12 weeks, up to 2 years