PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer . (NEOPEMBROV)
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|ClinicalTrials.gov Identifier: NCT03275506|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : January 11, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Stage IV||Drug: Pembrolizumab Injectable Product - Chemotherapy - Bev Drug: Chemotherapy - Bev||Phase 2|
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|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||open-label, multicentric|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Multicentric Phase II Trial of PEMBROLIZUMAB (Keytruda®) With Chemotherapy Versus Chemotherapy Alone (Standard of Care) as Neo Adjuvant Treatment of Ovarian Cancer Not Amenable to Front Line Debulking Surgery.|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
Experimental: Pembrolizumab + Chemo
Pembrolizumab (ketruda) 200 mg then carboplatin (AUC 5 or 6) and paclitaxel (175mg/m²), q3 weeks.
6 cyles 15 month total
Drug: Pembrolizumab Injectable Product - Chemotherapy - Bev
Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
Active Comparator: CHEMO alone
carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), q3 weeks. 6 cyles 15 month total
Drug: Chemotherapy - Bev
Carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
- evaluate the efficacy of neo adjuvant pembrolizumab and chemotherapy or chemo-therapy alone [ Time Frame: 5 years ]
The primary objective is to evaluate the efficacy of neo adjuvant pembrolizumab and chemotherapy or chemo-therapy alone measured by the complete resection rate after interval debulking surgery. Complete resection will be defined as the removal of all macroscopic residual tumor (CC score = 0)(Appendix 3)
Hypothesis: Neo adjuvant pembrolizumab in combination with chemotherapy improves the complete resection rate in patients not amenable to upfront debulking surgery.