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Étude NEOPEMBROV - Cancer Ovaire

En cours de lancement

Fiche descriptive de l'étude

Étude ovaire

NEOPEMBROV

Titre de l'étude

NEOPEMBROV : A randomized, open-label, multicentric phase II trial of PEMBROLIZUMAB (MK-3475) with chemotherapy versus chemotherapy alone (standard of care) as neo adjuvant treatment of ovarian cancer not amenable to front line debulking surgery.

Statut

Cette étude est en cours de lancement.

Sponsor / Promoteur

ARCAGY-GINECO

Study objectives and associated endpoints / But

PRIMARY OBJECTIVE

  • The primary objective is to evaluate the efficacy of neoadjuvant pembrolizumab and chemotherapy or chemotherapy alone measured by the complete resection rate after interval debulking surgery. Compete resection will be defined as the removal of all macroscopic residual tumor (CC score = 0).

SECONDARY OBJECTIVES

  • To evaluate the efficacy of the addition of pembrolizumab  to chemotherapy assessed by :
    • The Objective Response Rate at the time of interval debulking surgery (after 4 neo adjuvant cycles) using RECIST 1.1 criteria
    • The rate of the pCR
    • The Best Overall Response to the global strategy of interval debulking surgery + chemotherapy +/- Pembrolizumab (MK-3475) assessed by CT-Scan (using RECIST 1.1) at the end of treatment visit.
    • The Progression-Free Survival (PFS) using RECIST 1.1 criteria
    • Biological Progression-Free Interval (PFIBIO), measured according to the GCIG criteria
    • The overall survival
  • To assess the safety profile of neo adjuvant and adjuvant pembrolizumab when combined with standard of care, according to NCI CTC-AE v4.03.
  • To assess the Post-operative mortality
  • To assess the Post-operative morbidity (CCI) according to modified Clavien Dindo scoring.

EXPLORATORY OBJECTIVES

  • Response rate correlated to PD-L1 expression (yes or not) on tumor samples
  • Peritoneal Cancer Index assessment (PCI) before and after surgery

TRANSLATIONNAL RESEARCH OBJECTIVES

To improve the understanding of mechanism of action of pembrolizumab and resistance mechanisms

Phase

Phase II

Study population / Type de patiente

  • Be willing and able to provide written informed consent/assent for the trial.
  • Woman ³ 18 and ≤ 75 years old on day of signing informed consent
  • Histologically confirmed diagnosis of epithelial ovarian carcinoma or fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous histology. Histology should be obtained by laparoscopy (or by laparotomy).
  • Advanced FIGO stage IIIC to IV not able to received primary debluking surgery for which a neo adjuvant chemotherapy with carboplatin and paclitaxel is recommended.
  • Patients with extra abdominal metastasis (FIGO 2014 Stage IV) can be included in case of completely resectable metastasis.
  • Primary debulking surgery denied and maximum surgical effort of cytoreduction with the goal of no residual disease planned as interval debulking surgery, (i.e. Sugarbaker index less than 30)
  • Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards of care following cytoreductive surgery.
  • Debulking surgery anticipated in a center with excellence.
  • Patients with extra abdominal metastasis (FIGO 2014 Stage IV) can be included in case of completely resectable metastasis.
  • ECOG performance status (PS) ≤ 2.
  • Life expectancy of at least 6 months,
  • Interval between diagnosis and enrolment (informed consent) ≤ 8 weeks, 
  • Be willing to provide blood, and tissue from a newly obtained core or excisional biopsy of a tumor lesion.  Newly-obtained is defined as a specimen obtained up to 8 weeks (56 days) prior to initiation of treatment on Day 1. 
  • Demonstrate adequate organ function as defined in the table below, all screening labs should be performed within 8 days before randomization. 
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 8 days prior randomization.  If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
  • Patient should be beneficiary of healthcare coverage under the social security system.

Number of patients / Nombre de patientes à recrutées

Environ 90 patientes

Translational research / Critère principal d’évaluation

To improve the understanding of mechanism of action of pembrolizumab and resistance mechanisms Tumor Tissue Collection and Correlative Studies Blood Samplingwill be done:

  • Mandatory biological specimens: FFPE tumor biopsies at inclusion and surgical tumor specimen following neo-adjuvant treatment
  • Mandatory plasma/serum before treatment
  • Optional plasma/serum on treatment
  • Optional frozen PBMC before and on treatment
  • Optional fresh biological tumor specimen following neo-adjuvant therapy when available
  • Optional fresh whole blood before and on treatment
  • Optional biological specimens: frozen tumor biopsies at inclusion and surgical tumor specimen following neo-adjuvant treatment and associated PBMC

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Modifié le 06-10-2016 12:10