Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors

Sponsor
Hospital Beatriz Ângelo
Study ID
NCT03726281
Phase
PHASE2
Status
Withdrawn

Conditions

  • Germ Cell Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Oct 1, 2018
Status verified
Aug 2019
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single-arm trial of Nivolumab
    Multi-institutional, single arm phase II trial with Simon's optimal two-stage design, to evaluate the clinical benefit of Nivolumab monotherapy in patients with platinum-recurrent or platinum-refractory metastatic GCT. No randomization or blinding is involved.

Primary Outcome Measure

Clinical Benefit Rate (CBR, %) [ Time Frame: 3 months ]

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