Clinical trial · Interventional
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
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)
NCT00087022CI-TRIAL-00035945completedPhase 3Results postedClinicalTrials.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)
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.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| girentuximab | Biological | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
- interventionNames
- Biological: girentuximab
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Disease-free Survival
- timeFrame
- Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed primary clear cell renal cell carcinoma
* Meets 1 of the following high risk criteria:
* T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0
* Any T stage and N + disease and M0
* T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other nuclear grading system with at least 3 grades)
* Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks
* No evidence of macroscopic or microscopic residual disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Platelet count \> 100,000/mm\^3
* WBC \> 3,000/mm\^3
* Hemoglobin \> 10 g/dL
Hepatic
* AST and ALT \< 3 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Hepatitis B surface antigen (HbsAg) negative
* Hepatitis C antibody negative
Renal
* Creatinine \< 2.0 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV I and II negative
* No concurrent unrelated illness which can significantly jeopardize patients' clinical status
* No active infection
* No inflammation
* No medical condition or laboratory abnormalities that would preclude study participation
* No other malignancies within the past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 5 years since prior immunotherapy
* No prior murine or chimeric antibody therapy
Chemotherapy
* More than 5 years since prior chemotherapy
Endocrine therapy
* No concurrent corticosteroids above Cushing dose for another disease
* Physiologic corticosteroid replacement therapy allowed at discretion of the primary investigator
Radiotherapy
* More than 5 years since prior radiotherapy
Surgery
* See Disease Characteristics
* No prior organ transplantation
Other
* No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus)References
Publications (2)
- DERIVEDChamie K, Donin NM, Klopfer P, Bevan P, Fall B, Wilhelm O, Storkel S, Said J, Gambla M, Hawkins RE, Jankilevich G, Kapoor A, Kopyltsov E, Staehler M, Taari K, Wainstein AJA, Pantuck AJ, Belldegrun AS. Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):913-920. doi: 10.1001/jamaoncol.2016.4419. PMID 27787547
- DERIVEDDonin NM, Pantuck A, Klopfer P, Bevan P, Fall B, Said J, Belldegrun AS, Chamie K. Body Mass Index and Survival in a Prospective Randomized Trial of Localized High-Risk Renal Cell Carcinoma. Cancer Epidemiol Biomarkers Prev. 2016 Sep;25(9):1326-32. doi: 10.1158/1055-9965.EPI-16-0226. Epub 2016 Jul 14. PMID 27418270