drugset / Trial / NCT03298893

Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months (NiCOL)

NCT03298893 ↗

Phase 1/2 Completed 21 enrolled Institut Curie Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment

Summary

To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation.

Timeline

Start
2017-11-27
Primary completion
2020-10-30
Completion
2022-03-07

Outcome

Met primary endpoint

paper The pre-specified endpoints are met PMID 37349318 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 1 mg/kg —
Subject Nivolumab Monoclonal antibody 240 mg —
Background Cisplatin Other / unclassified 40 mg/m2 —

Indications