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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01743157

Acronym

BBI

Enrollment

Registered

2012-12-06

Start date

2010-12-31

Completion date

2013-05-31

Last updated

2013-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Brief summary

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI).

Detailed description

A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy (Temodar,Cisplatin, Velban,IL2 and IFN)plus Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)

Interventions

DRUGBiochemo + bevacizumab then ipilimumab

Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)	Primary Objective	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

Measure	Time frame	Description
A phase I-II study of treatment of metastatic melanoma using induction therapy with Biochemotherapy and Bevacizumab followed by consolidation therapy with Ipilimumab (BBI)	Secondary Objective	Compare median and overall progression-free survival to previously published historical control group of 135 patients receiving biochemotherapy followed by pulse IL-2, and also patients in the study of Weber et al (Reference 9) of ipilimumab in previously untreated patients for up to 4 years.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026