Trial Profile

Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for PD-L1 Positive Metastatic Triple Negative Breast Cancer

Status: Not yet recruiting

Phase of Trial: Phase I/II

Latest Information Update: 30 Jun 2025

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At a glance

Drugs Nivolumab (Primary) ; Nivolumab/relatlimab (Primary) ; Sacituzumab govitecan (Primary)
Indications HER2 negative breast cancer; Male breast cancer; Triple negative breast cancer
Focus Adverse reactions
Acronyms SIMONE

24 Jun 2025 Planned End Date changed from 1 Nov 2028 to 1 Aug 2030.
24 Jun 2025 Planned primary completion date changed from 1 Nov 2028 to 1 Aug 2030.
24 Jun 2025 Planned initiation date changed from 1 May 2025 to 1 Aug 2025.

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