drugset / Trial / NCT03726281
Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors
Phase 2
Withdrawn
Hospital Beatriz Ângelo
Bristol-Myers Squibb · collabUniversidade Nova de Lisboa · collabUniversidade do Porto · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2018-10-01
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
Outcome
Outcome not reported
Stopped: “End of Agreement between BMS and SGHL”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |