Clinical trial · Interventional
Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Based on the developments in the treatment of recurrent metastatic renal cancer, the study treatment is no longer considered to be the best treatment option
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment
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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab combined with temsirolimus
- description
- Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
- interventionNames
- Drug: Bevacizumab
- Drug: Temsirolimus
Primary outcomes (1)
- measure
- 6-month Progression Free Survival (PFS)
- timeFrame
- 32 months
- description
- Proportion of patients who are progression-free at 6month evaluation from treatment initiation
Secondary outcomes (7)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (18th year of age completed) * Signed and dated written informed consent form prior to any procedures related to this protocol. * Histologically confirmed advanced clear cell renal cancer. * Measurable disease. * Failure of first line anti-VEGF treatment. * Performance status 0-2, according to Eastern Cooperative Oncology Group (ECOG) . * Satisfactory hematological parameters: * White blood cell count \> 4000 mm3. * Platelet count 100000/mm3. * Neutrophil blood cell count \> 1200/ mm3 . * Hemoglobin \> 9,0 g/dL (can be achieved with red blood cell transfusion). * Satisfactory biochemical parameters: * Serum creatinine \< 2 x Upper Limit of Normal(ULN) * Aspartate Aminotransferase (AST)\<2,5 x ULN * Alanine Transaminase (ALT)\< 2,5 x ULN. * Bilirubin \<2 x ULN * (For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment). * (For female patients) Non-lactating women. * Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment. Exclusion Criteria: * Prior treatment with mTOR inhibitor. * Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment. * Uncontrolled hypertension. * Active infection requiring systemic treatment within 4 weeks prior to enrollment. * Minor surgery (for instance, catheter placement) within 2 days before enrollment. * Scheduled major surgery within the treatment period. * Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure. * Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment). * Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix). * History of non-healing wound including active gastric ulcer. * History of fistula in the last 6 months prior to enrollment. * History of gastrointestinal perforations. * Patient incapacity (for psychiatric or social reasons) to conform with the protocol. * History of hemorrhagic predisposition. * History of hypersensitivity to the medications under investigation. * Significant proteinurea. * Prior immunotherapy within 4 weeks prior to enrollment. * Prior radiation treatment within 2 weeks prior to enrollment. * Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4 (see Appendix 5 for an indicative list of active compounds). * Concurrent participation in other interventional clinical trials with investigational medicinal products. * History of chronic interstitial lung disease.
References
Publications (1)
- DERIVEDBamias A, Karavasilis V, Gavalas N, Tzannis K, Samantas E, Aravantinos G, Koutras A, Gkerzelis I, Kostouros E, Koutsoukos K, Zagouri F, Fountzilas G, Dimopoulos MA. The combination of bevacizumab/temsirolimus after first-line anti-VEGF therapy in advanced renal-cell carcinoma: a clinical and biomarker study. Int J Clin Oncol. 2019 Apr;24(4):411-419. doi: 10.1007/s10147-018-1361-9. Epub 2018 Oct 29. PMID 30374686