Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer
A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer
- 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. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV clear cell renal carcinoma * At least 1 site of measurable disease * Meeting criteria for 1 of the following: * Disease progression after prior interleukin-2 (IL-2) * Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions * Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 * Indolent disease (defined as an increase in tumor size of \< 50% within the past 6 months) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2 * No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal cancer PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * WBC ≥ 2,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Hematocrit ≥ 30% Hepatic * AST ≤ 3 times upper limit of normal (ULN) * Bilirubin ≤ ULN (\< 3.0 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2.0 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for at least 5 years * No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) * No active uncontrolled infection * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody * At least 3 weeks since prior immunotherapy for renal cancer Chemotherapy * At least 3 weeks since prior chemotherapy for renal cancer * No concurrent chemotherapy Endocrine therapy * At least 3 weeks since prior hormonal therapy for renal cancer * More than 4 weeks since prior corticosteroids * No concurrent systemic or topical corticosteroids Radiotherapy * At least 3 weeks since prior radiotherapy for renal cancer Surgery * Not specified Other * Recovered from prior therapy * At least 3 weeks since other prior therapy for renal cancer * No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
References
Publications (0)
Data not yet available