Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
CompletedPhase 2Results postedLast updated 20 March 2017
What this trial tests
Phase 2 trial testing RAD001(everolimus) in Carcinoma in 365 participants. Completed in 15 April 2013.
18 and older, any sex, with Carcinoma or Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus BevacizumabPrimary· Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a ne
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
9.3
8.1 – 11.2
Bevacizumab, Interferon Alfa-2a (IFN)
10.0
8.3 – 12.9
Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus BevacizumabSecondary· Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
27.1
19.9 – 35.3
Bevacizumab, Interferon Alfa-2a (IFN)
27.1
20.4 – 30.8
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus BevacizumabSecondary· Time from first participant randomized until 31Dec2011, cutoff date.
Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% inc
Complete response (CR)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
0
Bevacizumab, Interferon Alfa-2a (IFN)
1
Partial response (PR)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
49
Bevacizumab, Interferon Alfa-2a (IFN)
50
Stable disease (SD)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
90
Bevacizumab, Interferon Alfa-2a (IFN)
84
Progressive disease (PD)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
25
Bevacizumab, Interferon Alfa-2a (IFN)
26
Unknown response
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
18
Bevacizumab, Interferon Alfa-2a (IFN)
22
Overall objective response (CR+PR)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
49
Bevacizumab, Interferon Alfa-2a (IFN)
51
Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus BevacizumabSecondary· Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
13.3
10.7 – 16.7
Bevacizumab, Interferon Alfa-2a (IFN)
11.3
10.4 – NA
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and DeathsSecondary· From the first participant randomized until the last patient discontinued the study treatment + 28 days
Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
Adverse events (serious and non-serious)
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
179
Bevacizumab, Interferon Alfa-2a (IFN)
180
Serious adverse events
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
79
Bevacizumab, Interferon Alfa-2a (IFN)
76
Deaths
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
93
Bevacizumab, Interferon Alfa-2a (IFN)
95
Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score UnitsSecondary· Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
7.4
4.7 – 10.8
Bevacizumab, Interferon Alfa-2a (IFN)
8.0
3.7 – 11.5
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%Secondary· Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioratio
Global health status/QoL
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
7.4
5.3 – 12.0
Bevacizumab, Interferon Alfa-2a (IFN)
7.8
5.6 – 10.2
Physical functioning
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
8.5
5.6 – 13.8
Bevacizumab, Interferon Alfa-2a (IFN)
9.0
6.5 – 12.9
Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and BevacizumabSecondary· From the date of the first participant treated until the last patient discontinued the study treatment + 28 days
This outcome measure was assessed continuously.
Group
Value
95% CI
Bevacizumab, RAD001 (Everolimus)
37.0
2 – 190
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07257094 — Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Reha
· recruiting
NCT06969534 — Safety and Efficacy of Pucotenlimab in pLECC
· Phase 2
· recruiting
NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
· recruiting
NCT07470827 — Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions
· active not recruiting
NCT06317311 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recu
· Phase 2
· active not recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 20 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00719264.