PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer .

Summary

There are several data suggesting that pembrolizumab and bevacizumab may be synergistic. Enhanced tumor angiogenesis is commonly associated with absence of tumor-infiltrating T cells in patients. There is evidence in OC that tumor expression of VEGF is negatively correlated to the density of CD3+TILs and this phenotype is associated with early recurrence, consistent with prior studies showing a correlation of VEGF to early recurrence and short survival. Furthermore, in ascites, high levels of VEGF correlate to low numbers of NK T-like CD3+CD56+ cells This randomized phase II study aims to evaluate the efficacy of pembrolizumab in combina-tion with the standard neo adjuvant chemotherapy followed by IDS and the safety of this strategy in patients with advanced ovarian cancer. We assume that its administration in the neo adjuvant setting combination with standard of care (4 cycles of standard chemotherapy) would improve the response rate and consequently will help to achieve optimal debulking rate at IDS. After surgery, patients will continue to be treated with standard of care (chemotherapy for 2 to 5 cycles plus or less bevacizumab) or the same combination plus pembrolizumab (keytruda).

Timeline

Start

2018-02-26

Primary completion

2020-09-30

Completion

2024-03-19

Publications

• Collet L, Ardin M, Venet D, Berthet J, Ghamry-Barrin S, Treilleux I, Noel JC, Leheurteur M, Meunier J, Bengrine Lefevre L, Martinez M, Priou F, Selle F, Just PA, Bataillon G, Rothe F, Sotiriou C, Caux C, Dubois B, Ray-Coquard I, Le Saux O. Unraveling the Tumor Microenvironment and PD-L1 Expression across Tissue Types in High-Grade Serous Ovarian Cancer in the NeoPembrOV/GINECO Phase II Randomized Trial. Clin Cancer Res. 2025 Aug 1;31(15):3317-3331. doi: 10.1158/1078-0432.CCR-24-2712.

Drugs

Indications