Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05468294
Brief Summary:
Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.
Detailed Description:
The study will take place in two phases. In Phase I, the MTD and RD will be defined following a traditional 3+3 design and patients will be treated in cohorts of 3 to 6 patients with a fixed dose of Nivolumab (3 mg/kg) and escalating doses of F16IL2.
Following successful completion of the dose-finding, the study will proceed to Phase IIb and 17 patients will be treated with Nivolumab (3 mg/kg) and F16IL2 at the RD determined in Phase I.
Study:
NCT05468294
Study Brief:
Protocol Section:
NCT05468294