PEMBRO With Chemo in Neo Adj Treatment of Ovarian Cancer .

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT03275506
Phase
PHASE2
Status
Completed

Conditions

  • Ovarian Cancer Stage IV

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

First listed
Sep 7, 2017
Start date
Feb 26, 2018
Status verified
Sep 2025
Primary completion
Sep 30, 2020
Completion
Mar 19, 2024

Study Design

Enrollment
91 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Chemotherapy
    Arm B (n=60): 4 neo-adjuvant cycles of standard 3 weekly Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²) Arm B: Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W) The total number of cycles of chemotherapy will be 6 cycles from the start of the neo-adjuvant chemotherapy. Three additional cycles are allowed if required (maximum 9 cycles in total). The planning of administration or not of bevacizumab will be defined before the randomization and could not be modified (stratification factor). After chemotherapy: * In the Arm A \& B, for patients receiving bevacizumab (as standard therapy) (15 mg/kg Q3W), this will be continue until a maximum of 15 months in total from the beginning of the adjuvant therapy. * In the arm B, patient will receive Pembrolizumab 200 mg until a maximum of 15 months in total from the beginning of the adjuvant therapy.
  • Active Comparator: Chemotherapy alone
    Arm A (n=30): 4 neo-adjuvant cycles of standard 3 weekly carboplatin (AUC5 or 6) and paclitaxel (175mg/m²) Arm A: carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), q3 weeks +/- bevacizumab (15 mg/kg Q3W) The total number of cycles of chemotherapy will be 6 cycles from the start of the neo-adjuvant chemotherapy. Three additional cycles are allowed if required (maximum 9 cycles in total). The planning of administration or not of bevacizumab will be defined before the randomization and could not be modified (stratification factor). After chemotherapy: \- In the Arm A \& B, for patients receiving bevacizumab (as standard therapy) (15 mg/kg Q3W), this will be continue until a maximum of 15 months in total from the beginning of the adjuvant therapy.

Primary Outcome Measure

Primary objective [ Time Frame: Average of 4 months after the randomization of the last patient. ]

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