A Phase 3 interventional study of girentuximab and placebo in Kidney Cancer, sponsored by Heidelberg Pharma AG. Completed at 56 sites in 4 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-11-27.
Sponsored by Heidelberg Pharma AG · Phase 3, Interventional, and Treatment
Among 551 studies in Kidney Neoplasms with a site in United States — 67 open to participants now, 109 under way, 4 of them phase 3. Kidney Neoplasms · United States.
Among the 551 studies in Kidney Neoplasms with a site in United States, this one is the 7th largest by enrollment of the 443 interventional ones, is one of 24 that started in 2004, is one of 30 in phase 3, and was the 122nd registered.
969 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's enrollment of 864 is above the median of 46 across 668 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →67 of the 551 studies in Kidney Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 173 Kidney Neoplasms studies recruiting now, 133 (77%) set no upper age limit and 15 (9%) stop at 75 or younger; 20 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →551 studies; the count open now beside each. This study's row is marked.
First in 1990; this study’s year is marked. 24 started in 2004.
Median enrollment 37 across the 443 interventional studies, 350 across the 62 observational. Of the 410 that completed or were terminated, 156 (38%) have results posted.
154 of 551 have an industry lead sponsor. The 10 most frequent:
Heidelberg Pharma AG is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Heidelberg Pharma AG has 3 studies filed under Kidney Neoplasms — fewer than ten, so there is no comparison to draw.
42 of the studies in Kidney Neoplasms with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07814872Harvard Medical School (HMS and HSDM)A Preregistered Multi-Cohort Evaluation of the FATHOM AI System for Molecular Testing Prioritization to Support Clinical Trial Enrollment | 2026-11 |
| NCT06234605HiberCell, Inc.A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma | 2026-11 |
| NCT05969496University of Colorado, DenverNeoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus | 2026-11-01 |
| NCT00582621Memorial Sloan Kettering Cancer CenterAscertainment of Families for Genetic Studies of Familial Lymphoproliferative Disorders | 2026-12 |
| NCT06964958Dana-Farber Cancer Institute177LuPSMA in Renal Cell Carcinoma | 2026-12-01 |
Among the 551 studies in Kidney Neoplasms with a site in United States, from their registry updates:
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk criteria and participating centers (US vs Non-US). Patients are randomized to 1 of 2 treatment arms.
Blood samples are collected for pharmacokinetic analysis.
Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6 months after completion of study treatment.
Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and 4, and then annually during year 5 and thereafter.
PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm) were accrued for this trial.
DISEASE CHARACTERISTICS:
confirmed primary clear cell renal cell carcinoma
Meets 1 of the following high risk criteria:
Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent above Cushing dose for another disease
Radiotherapy
Surgery
Other
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
Biological: girentuximab
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
Other: placebo
Given IV
Also known as: Rencarex®, cG250 and WX-G250
Given IV
Disease-free Survival
Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
Time frame: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Overall Survival
Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.
Time frame: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)
Quality of Life - Global Health Status
Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.
Time frame: At 12 months
Pharmacokinetics of WX-G250
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
Time frame: Week 8
| Milestone | Intervention | Placebo |
|---|---|---|
| Started | 433 | 431 |
| Treated (safety population) | 431 | 424 |
| Completed | 379 | 376 |
| Not completed | 54 | 55 |
Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
| Participants | Intervention | Placebo |
|---|---|---|
| Disease-free Survival | 192 | 197 |
Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.
| Participants | Intervention | Placebo |
|---|---|---|
| Overall Survival | 91 | 90 |
Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.
| score on a scale | Intervention | Placebo |
|---|---|---|
| Quality of Life - Global Health Status | 71 ± 21 | 71 ± 20 |
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
| µg/mL | Intervention |
|---|---|
| Pharmacokinetics of WX-G250 | 8.7 ± 5.8 |
This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6. The CAIX score is determined on the basis of CAIX expression via immunohistochemistry described by a combination of tumor cell extent and staining intensity. Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
| Participants | Intervention | Placebo |
|---|---|---|
| Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6 | 20 | 39 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 36/431 (8.4%) | 164/431 (38.1%) |
| Placebo | — | 36/424 (8.5%) | 166/424 (39.2%) |
| Event | Intervention | Placebo |
|---|---|---|
| PNEUMONIAInfections and infestations | 0/431 | 2/424 |
| PROSTATE CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/431 | 2/424 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 2/431 | 2/424 |
| MYOCARDIAL INFARCTIONCardiac disorders | 2/431 | 1/424 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 1/431 | 1/424 |
| CARDIAC FAILURECardiac disorders | 0/431 | 1/424 |
| CHEST DISCOMFORTCardiac disorders | 0/431 | 1/424 |
| DIARRHOEAGastrointestinal disorders | 0/431 | 1/424 |
| DUODENAL ULCER PERFORATIONGastrointestinal disorders | 0/431 | 1/424 |
| GASTRIC ULCERGastrointestinal disorders | 1/431 | 1/424 |
| Event | Intervention | Placebo |
|---|---|---|
| HEADACHENervous system disorders | 40/431 | 39/424 |
| DIARRHOEAGastrointestinal disorders | 27/431 | 39/424 |
| FATIGUEGeneral disorders | 28/431 | 39/424 |
| BACK PAINMusculoskeletal and connective tissue disorders | 34/431 | 37/424 |
| NAUSEAGastrointestinal disorders | 35/431 | 29/424 |
| HYPERTENSIONVascular disorders | 34/431 | 25/424 |
| NASOPHARYNGITISInfections and infestations | 30/431 | 33/424 |
| VOMITINGGastrointestinal disorders | 28/431 | 18/424 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 27/431 | 22/424 |
| ASTHENIAGeneral disorders | 19/431 | 22/424 |
All patients that were enrolled were included in the ITT population used for efficacy analysis; only 855 patients received at least one dose of study treatment and were analyzed for safety (Safety Population, SP)
| Age, Continuous(years) | Intervention | Placebo | Total |
|---|---|---|---|
| Mean | 58.2 ± 9.83 | 57.8 ± 10.1 | 58.0 ± 9.98 |
| Sex: Female, Male(Participants) | Intervention | Placebo | Total |
|---|---|---|---|
| Female | 157 | 133 | 290 |
| Male | 276 | 298 | 574 |
The record gives a start of Jul 2004, a primary completion of Oct 2012 and a completion of Oct 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2018, 5 years 11 months after primary completion. A results delay was requested in Jan 2014.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: G250 monoclonal antibody
Heidelberg Pharma AG