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Carboplatin-Paclitaxel-Pembrolizumab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer — MITO CERV 3  

Locally Advanced Cervical Cancer Clinical Trial

Official title:
Phase II Study on Carboplatin-Paclitaxel-Pembrolizumab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer

Clinical Trial Summary

Single arm multicenter phase II trial evaluating the role of Pembrolizumab in combination to Carboplatin-Paclitaxel chemotherapy in locally advanced cervical cancer patients.

Clinical Trial Description

Patients with stage IB2-IIB cervical cancer will be treated with 3 cycles of neoadjuvant Carboplatin-Paclitaxel chemotherapy (Carboplatin AUC 5 d1 q 21+ Paclitaxel 175 mg/mq d1 q 21)+ Pembrolizumab (200 mg flat dose every 3 weeks). After 3 cycles of neo-adjuvant platinum-based chemotherapy patients non progressing will undergo radical surgery. After surgery, patients presenting with high risk factors (positive lymphnodes, positive parametria, positive surgical margins or at least 2 of the following risk factor between tumor diameter >3 cm, LVSI, stromal infiltration >1/3) will receive 3 cycles of adjuvant Carboplatin-Paclitaxel chemotherapy + Pembrolizumab in combination and maintenance with Pembrolizumab 200 mg every 3 weeks until progression or unacceptable toxicity or patient consent withdrawal for up to 35 cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04238988
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Domnica Lorusso, MD
Phone 0630157337
Email domenica.lorusso@policlinicogemelli.it
Status Recruiting
Phase Phase 2
Start date February 18, 2021
Completion date September 1, 2023
View Details
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