Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors
Status:
Withdrawn
Trial end date:
2019-06-30
Target enrollment:
Participant gender:
Summary
To assess the clinical activity of nivolumab monotherapy, as measured by the
investigator-assessed clinical benefit rate (CBR), in patients with platinum-recurrent or
platinum-refractory metastatic germ cell tumors (GCT). CBR is defined by sum of complete
responses (CR), partial responses (PR) and stable disease (SD) for at least 3 months, with
stable or declining tumor markers (αFP and HCG), using Response Evaluation Criteria In Solid
Tumors (RECIST 1.1).
Phase:
Phase 2
Details
Lead Sponsor:
Hospital Beatriz Ângelo
Collaborators:
Bristol-Myers Squibb Instituto de Patologia e Imunologia Molecular da Universidade do Porto Universidade Nova de Lisboa