Clinical trial · Interventional
Brentuximab Vedotin (SGN-35) as Salvage Treatment for CD30-positive Germ Cell Tumors
Brentuximab Vedotin (SGN-35) as Salvage Therapy for Males With Advanced and Platinum-resistant Germ-cell Tumors. An Open Label, Single Group, Phase 2 Trial.
NCT01851200CI-TRIAL-00031571completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to assess the activity of Brentuximab vedotin in refractory germ cell tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Cancer | Malignant Germ Cell Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab Vedotin
- description
- Intravenous Brentuximab Vedotin at the dose of 1.8 mg/Kg every 3 weeks until disease progression or onset of unacceptable toxicity
- interventionNames
- Drug: Brentuximab Vedotin
Primary outcomes (1)
- measure
- The number of objective responses (partial and complete responses) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 integrated with response of serum tumor markers.
- timeFrame
- Six weeks after the first administration of the study drug.
Secondary outcomes (3)
- measure
- Progression-Free Survival
- timeFrame
- 3 months after the initiation of study treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age of at least 18 years. * Confirmation of germ cell tumor histology based on pathologic review at the study site. * Presence of a CD30 positive embryonal carcinoma component. * Unequivocal progression of measurable disease. * A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease EXCEPT for primary mediastinal germ cell tumors where failure of first-line chemotherapy only is accepted. * Prior high dose chemotherapy with hematopoietic stem cell rescue is allowed. Exclusion Criteria: * Failure to meet any of the above inclusion criteria. * Patients with late-relapse (defined as relapse occurring after at least 2 years from the date of completion of the last chemotherapy regimen) whose disease is completely surgically resectable (and for whom initial surgical extirpation is recommended) are ineligible. Patients with unresectable late disease relapse are eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.