Trial Outcomes & Findings for Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer (NCT NCT00087022)
NCT ID: NCT00087022
Last Updated: 2018-11-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
864 participants
Primary outcome timeframe
Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Results posted on
2018-11-27
Participant Flow
Participant milestones
| Measure |
Intervention
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex, girentuximab, and WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
433
|
431
|
|
Overall Study
Treated (Safety Population)
|
431
|
424
|
|
Overall Study
COMPLETED
|
379
|
376
|
|
Overall Study
NOT COMPLETED
|
54
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=433 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=431 Participants
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
Total
n=864 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
574 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)Population: All patients that were enrolled were included in the ITT population used for efficacy analysis
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.
Outcome measures
| Measure |
Intervention
n=433 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=431 Participants
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Disease-free Survival
|
192 Participants
|
197 Participants
|
PRIMARY outcome
Timeframe: 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)Population: All patients that were enrolled were included in the ITT population used for efficacy analysis
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.
Outcome measures
| Measure |
Intervention
n=433 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=431 Participants
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Overall Survival
|
91 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Patients still on study who completed the questionnaire
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.
Outcome measures
| Measure |
Intervention
n=295 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=315 Participants
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Quality of Life - Global Health Status
|
71 score on a scale
Standard Deviation 21
|
71 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Week 8Population: Patients who did sign amendment #3 to the study protocol and received their cG250 infusion as scheduled in the study protocol
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
Outcome measures
| Measure |
Intervention
n=340 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Pharmacokinetics of WX-G250
|
8.7 µg/mL
Standard Deviation 5.8
|
—
|
POST_HOC outcome
Timeframe: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)Population: This analysis includes patients having a CAIX Expression equal or above the CAIX score of 2.6.
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.
Outcome measures
| Measure |
Intervention
n=69 Participants
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=82 Participants
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Disease Free Survival (DFS) for Patients With CAIX Score >= 2.6
|
20 Participants
|
39 Participants
|
Adverse Events
Intervention
Serious events: 36 serious events
Other events: 164 other events
Deaths: 0 deaths
Placebo
Serious events: 36 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=431 participants at risk
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=424 participants at risk
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.23%
1/431
|
0.00%
0/424
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.23%
1/431
|
0.00%
0/424
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.23%
1/431
|
0.24%
1/424
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.23%
1/431
|
0.00%
0/424
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/431
|
0.24%
1/424
|
|
Cardiac disorders
CHEST DISCOMFORT
|
0.00%
0/431
|
0.24%
1/424
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.46%
2/431
|
0.24%
1/424
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.23%
1/431
|
0.00%
0/424
|
|
Gastrointestinal disorders
ASCITES
|
0.23%
1/431
|
0.00%
0/424
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/431
|
0.24%
1/424
|
|
Gastrointestinal disorders
DUODENAL ULCER PERFORATION
|
0.00%
0/431
|
0.24%
1/424
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.23%
1/431
|
0.24%
1/424
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.23%
1/431
|
0.00%
0/424
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.23%
1/431
|
0.00%
0/424
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.23%
1/431
|
0.00%
0/424
|
|
General disorders
CHEST PAIN
|
0.00%
0/431
|
0.24%
1/424
|
|
Hepatobiliary disorders
BILIARY DILATATION
|
0.23%
1/431
|
0.00%
0/424
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.23%
1/431
|
0.00%
0/424
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/431
|
0.47%
2/424
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
0.00%
0/431
|
0.24%
1/424
|
|
Infections and infestations
PYELONEPHRITIS
|
0.23%
1/431
|
0.00%
0/424
|
|
Infections and infestations
SINUSITIS
|
0.23%
1/431
|
0.00%
0/424
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.23%
1/431
|
0.00%
0/424
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.00%
0/431
|
0.24%
1/424
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.23%
1/431
|
0.00%
0/424
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.23%
1/431
|
0.00%
0/424
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.23%
1/431
|
0.00%
0/424
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/431
|
0.24%
1/424
|
|
Investigations
BIOPSY LUNG
|
0.00%
0/431
|
0.24%
1/424
|
|
Investigations
MEDIASTINOSCOPY
|
0.00%
0/431
|
0.24%
1/424
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/431
|
0.24%
1/424
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/431
|
0.24%
1/424
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/431
|
0.24%
1/424
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.23%
1/431
|
0.24%
1/424
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/431
|
0.24%
1/424
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.00%
0/431
|
0.24%
1/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.00%
0/431
|
0.24%
1/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.23%
1/431
|
0.00%
0/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.23%
1/431
|
0.24%
1/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.23%
1/431
|
0.24%
1/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
|
0.23%
1/431
|
0.00%
0/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CYST
|
0.23%
1/431
|
0.00%
0/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.46%
2/431
|
0.47%
2/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECURRENT CANCER
|
0.00%
0/431
|
0.24%
1/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SALIVARY GLAND CANCER
|
0.23%
1/431
|
0.00%
0/424
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.23%
1/431
|
0.24%
1/424
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.23%
1/431
|
0.00%
0/424
|
|
Nervous system disorders
HEADACHE
|
0.23%
1/431
|
0.24%
1/424
|
|
Nervous system disorders
PERIPHERAL NERVE LESION
|
0.00%
0/431
|
0.24%
1/424
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.00%
0/431
|
0.24%
1/424
|
|
Renal and urinary disorders
HAEMATURIA
|
0.23%
1/431
|
0.24%
1/424
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.23%
1/431
|
0.00%
0/424
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/431
|
0.24%
1/424
|
|
Reproductive system and breast disorders
OVARIAN MASS
|
0.23%
1/431
|
0.00%
0/424
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/431
|
0.24%
1/424
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.46%
2/431
|
0.47%
2/424
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.23%
1/431
|
0.00%
0/424
|
|
Surgical and medical procedures
COLON POLYPECTOMY
|
0.00%
0/431
|
0.24%
1/424
|
|
Surgical and medical procedures
MALIGNANT TUMOUR EXCISION
|
0.23%
1/431
|
0.00%
0/424
|
|
Surgical and medical procedures
RENAL TUMOUR EXCISION
|
0.23%
1/431
|
0.00%
0/424
|
|
Surgical and medical procedures
THYROID OPERATION
|
0.00%
0/431
|
0.24%
1/424
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.23%
1/431
|
0.00%
0/424
|
Other adverse events
| Measure |
Intervention
n=431 participants at risk
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes as a single loading dose of 50 mg (week 1) followed by weekly infusions of 20 mg of WX-G250 (weeks 2-24).
girentuximab: Given IV
|
Placebo
n=424 participants at risk
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
placebo: Given IV
|
|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.3%
27/431
|
9.2%
39/424
|
|
Gastrointestinal disorders
NAUSEA
|
8.1%
35/431
|
6.8%
29/424
|
|
Gastrointestinal disorders
VOMITING
|
6.5%
28/431
|
4.2%
18/424
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.9%
34/431
|
8.7%
37/424
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.3%
27/431
|
5.2%
22/424
|
|
Infections and infestations
NASOPHARYNGITIS
|
7.0%
30/431
|
7.8%
33/424
|
|
General disorders
FATIGUE
|
6.5%
28/431
|
9.2%
39/424
|
|
General disorders
ASTHENIA
|
4.4%
19/431
|
5.2%
22/424
|
|
Nervous system disorders
HEADACHE
|
9.3%
40/431
|
9.2%
39/424
|
|
Vascular disorders
HYPERTENSION
|
7.9%
34/431
|
5.9%
25/424
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60