Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00790010
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab Plus Ipilimumab Cohort 1 — DRUG
    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)
  • Bevacizumab Plus Ipilimumab Cohort 2 — DRUG
    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)
  • Bevacizumab Plus Ipilimumab Cohort 3 — DRUG
    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)
  • Bevacizumab Plus Ipilimumab Cohort 4 — DRUG
    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)

Study Details

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.

Key Dates

Start date
Feb 26, 2009
Status verified
May 2023
Primary completion
Jun 22, 2018
Completion
Jun 22, 2018

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab Plus Ipilimumab Cohort 1
    5 subjects for this cohort
  • Experimental: Bevacizumab Plus Ipilimumab Cohort 2
    17 subects for this cohort
  • Experimental: Bevacizumab Plus Ipilimumab Cohort 3
    12 subjects
  • Experimental: Bevacizumab Plus Ipilimumab Cohort 4
    12 subjects

Primary Outcome Measure

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 [ Time Frame: 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02214-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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