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Avelumab in Refractory Testicular Germ Cell Cancer.

NCT03403777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-03-05

No results posted yet for this study

Summary

This is a proof-of-concept study to define efficacy of AVELUMAB in patients with multiple relapsed/refractory germ cell tumors (GCTs). Data suggest that PD-L1 is overexpressed in TGCTs, and PD-L1 expression is significantly higher in GCTs in comparison to normal testicular tissue.Patients with low PD-L1 expression had significantly better progression-free survival (hazard ratio \[HR\] = 0.40, 95% CI (0.16 - 1.01, p = 0.008) and overall survival (HR = 0.43, 95% CI (0.15 - 1.23, p = 0.040) compared to patients with high PD-L1 expression. These data suggest that PD-1/PD-L1 pathway could be a novel therapeutic target in TGCTs and that there is strong rationale to inhibit PD-1/PD-L1 signaling in GCTs.

Conditions

  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neoplasms
  • Testicular Diseases
  • Gonadal Disorders
  • Antineoplastic Agents
  • Molecular Mechanisms of Pharmacological Action

Interventions

DRUG

Avelumab

AVELUMAB will be administered intravenously 10mg/kg every 2 weeks.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • National Cancer Institute, Slovakia

    lead OTHER_GOV

Principal Investigators

  • Michal Mego, prof · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Slovakia

Study Locations

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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 NCT03403777 on ClinicalTrials.gov