Clinical trial · Interventional
Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab for Metastatic Melanoma
A Phase I-II Study of Treatment of Metastatic Melanoma Using Induction Therapy With Biochemotherapy and Bevacizumab Followed by Consolidation Therapy With Ipilimumab (BBI)
NCT01743157CI-TRIAL-00011950BBIcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biochemo + bevacizumab then ipilimumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biochemo + Bevacizumab then Ipilimumab
- description
- Single arm: Biochemotherapy with 4 cycles at 3 week intervals of Temozolamide 150mg/m2 x4, cisplatin 20mg/m2 x 4, vinblastine 1.2mg/m2 x 4, bevacizumab 7.5-15 mg/kg x 1, interferon 5mg/m2 x5 and aldesleukin 36,18,9, % 9 miu/day over 4 days each cycle; then ipilimumab 3mg/kg q 21 days x 4, then q 3 months x 8 for total 3 years.
- interventionNames
- Drug: Biochemo + bevacizumab then ipilimumab
Primary outcomes (1)
- measure
- A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)
- timeFrame
- Primary Objective
- description
- Determine the incidence of grade 4 bevacizumab-related toxicities and grade 3 proteinuria when bevacizumab is given with biochemotherapy to patients with metastatic melanoma for up to 3 years.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage 4 or unresectable stage 3 metastatic melanoma with or without measurable disease 2. Age 18-70 years old 3. Adequate pulmonary and cardiac function for high-dose IL-2 4. PS 0-2 5. Previous ipilimumab therapy will not exclude patients, but patients with previous ipilimumab will have separate efficacy analysis Exclusion Criteria: 1. Brain metastases 2. Creatinine \> 2x ULN; bilirubin \> 3, WBC \< 3500, Platelets \< 100,000, Hgb \< 9 3. Another active malignancy 4. Gastrointestinal tract metastases except rectal metastases or primary are allowable 5. Previous therapy for metastatic disease with chemotherapy of duration over 3 months or with high-dose interleukin-2 6. History of colitis or autoimmune disease such as lupus or rheumatoid arthritis 7. Bevacizumab-related contraindications: Hemoptysis or history of severe bleeding, uncontrolled hypertension, proteinuria with protein/creatinine ratio \> 1, acute myocardial infarction within 6 months
References
Publications (1)
- RESULT3. Minor DR, Wang W, Kashani-Sabet: Concurrent bevacizumab (BEV) with biochemotherapy (BIO) followed by ipilimumab for advanced melanoma: a phase I-II trial. J Clin Onc 2013 (suppl; abstr e200001)