Pembrolizumab in Subjects with Advanced Recurrent Ovarian Cancer

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-003338-29

Femme Homme

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Extrait

(1) To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on overall response rate (ORR) as assessed by CIV per RECIST 1.1 in Cohort A-All Comer group (2) To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by CIV per RECIST 1.1 in Cohort A- PD-L1 High (PD-L1H) subgroup using a PD-L1 expression cutpoint established in the training set. (3) To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by CIV per RECIST 1.1 in Cohort B-All Comer group (4) To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by CIV per RECIST 1.1 in Cohort B PD-L1H subgroup using a PD-L1 expression cutpoint established in the training set from Cohort A


Critère d'inclusion

  • A:platinum-resistant or partially platinum-sensitive recurrent ovarian cancer (OC) who received 1 but no more than 3 prior lines of anticancer regimens/local standard following primary or interval debulking surgery with a platinum free interval or treatment-free interval of 3-12 months based on last regimen received
  • B:recurrent OC who received 3-5 prior lines of anticancer regimens/local standard with a platinum-free interval or treatment-free interval >or=3months based on last regimen received