MedTrace Logo

Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors

NCT03726281 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-08-21

No results posted yet for this study

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).

Conditions

  • Germ Cell Tumors

Interventions

DRUG

Nivolumab

Nivolumab 240 mg, IV

Sponsors & Collaborators

  • Universidade Nova de Lisboa

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Instituto de Patologia e Imunologia Molecular da Universidade do Porto

    collaborator UNKNOWN

  • Hospital Beatriz Ângelo

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03726281 on ClinicalTrials.gov