CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 864 enrolled
Drug / intervention
girentuximab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically confirmed primary clear cell renal cell carcinoma
  • ✓High-risk disease by TNM staging: T3a-T4 N0/NX M0, or any T stage with N+ M0 disease, or T1b-T2 N0/NX M0 with grade ≥3 (Fuhrman or equivalent)
  • ✓Prior nephrectomy (total or partial) within 12 weeks with documented clear cell histology and no macroscopic or microscopic residual disease
  • ✓Age ≥18 years
Key exclusion· 9
  • ✕Prior murine or chimeric antibody therapy
  • ✕Prior immunotherapy within 5 years
  • ✕Prior chemotherapy within 5 years
  • ✕Prior radiotherapy within 5 years

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00087022
NCT00087022Phase 3Completed
CompareCT.gov

A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)

Heidelberg Pharma AG·interventional·Posted Jul 12, 2004·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating girentuximab and placebo for Kidney Cancer. Completed, enrolled 864 participants across 56 sites in 4 countries.

Detailed Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer. PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesArgentina, Brazil, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartJul 1, 2004
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 22.0 years ago

Interventions

girentuximabbiological

Given IV

placeboother

Given IV