Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
A Phase I Trial of Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
3 other identifiers
interventional
46
1 country
3
Brief Summary
The purpose of this research study is to determine the safety of using the study drugs bevacizumab and ipilimumab together, and the doses in combination which can be given to people safely. This study also seeks to investigate whether using both study drugs lengthens the amount of time before the participants melanoma worsens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2009
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedStudy Start
First participant enrolled
February 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2018
CompletedMay 11, 2023
May 1, 2023
9.3 years
November 12, 2008
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the safety, tolerability and maximum tolerated dosing for the combination of bevacizumab plus ipilimumab in patients with unresectable stage III or stage IV melanoma
3 years
Secondary Outcomes (2)
To determine the best overall response rate by standard solid tumor response criteria, disease control rate, time to tumor progression, and duration of response for the combination of bevacizumab plus ipilimumab in this patient population
3 years
To perform correlative studies investigating the effects of this combination therapy on antitumor immunity and tumor vasculature
3 years
Study Arms (4)
Bevacizumab Plus Ipilimumab Cohort 1
EXPERIMENTAL5 subjects for this cohort
Bevacizumab Plus Ipilimumab Cohort 2
EXPERIMENTAL17 subects for this cohort
Bevacizumab Plus Ipilimumab Cohort 3
EXPERIMENTAL12 subjects
Bevacizumab Plus Ipilimumab Cohort 4
EXPERIMENTAL12 subjects
Interventions
Cohort 1: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
Cohort 2: Ipilimumab 10 mg/kg IV every 3 weeks x 4 doses(induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)
Cohort 3: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 7.5 mg/kg IV every 3 weeks (continuous)
Cohort 4: Ipilimumab 3 mg/kg IV every 3 weeks x 4 doses (induction), then every 3 months (maintenance); Bevacizumab 15 mg/kg IV every 3 weeks (continuous)
Eligibility Criteria
You may qualify if:
- Measurable unresectable Stage III or Stage IV melanoma
- ECOG Performance Status 0 or 1
- weeks or greater since treatment
- Must have recovered from any acute toxicity associated with prior therapy
- Life expectancy of greater than 12 weeks
- years of age or older
- Laboratory values as outlined in protocol
- Negative screening tests for HIV, active Hepatitis B and Hepatitis C
- Patients who received prior therapy with anthracyclines should have a baseline MUGA or echo with a normal ejection fraction
You may not qualify if:
- CNS metastases
- Pregnant or nursing women
- Prior therapy with bevacizumab or ipilimumab
- Active infection
- Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic autoimmune disease
- Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- Any concurrent medical condition requiring the use of systemic steroids
- Inadequately controlled hypertension
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- NYHA Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke of transient ischemic attack within 6 months prior to study enrollment
- Significant known vascular disease
- Symptomatic peripheral vascular disease
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Genentech, Inc.collaborator
- Bristol-Myers Squibbcollaborator
Study Sites (3)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02214, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Melanoma Disease Center Director
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
February 26, 2009
Primary Completion
June 22, 2018
Study Completion
June 22, 2018
Last Updated
May 11, 2023
Record last verified: 2023-05