A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Elizabeth Buchbinder, MD
Study ID
NCT04356729
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Stage IV Melanoma
  • Unresectable Stage III Cutaneous Melanoma
  • Unresectable Stage IV Cutaneous Melanoma

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks ith 21 consecutive days defined as a treatment cycle.
  • Bevacizumab — DRUG
    Bevacizumab will be administered intravenously at a fixed predetermined dose every three weeks, with 21 consecutive days defined as a treatment cycle.

Study Details

This research study is studying a combination of two drugs that change the immune system and tumor as a possible treatment for metastatic or unresectable stage III or IV cutaneous melanoma. The names of the study drugs involved in this study are: * Atezolizumab * Bevacizumab

Key Dates

Start date
Aug 6, 2020
Status verified
Jun 2025
Primary completion
Jun 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab and Bevacizumab
    The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits. * Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks * Bevacizumab will be administered intravenously at a fixed predetermined dose every three weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis Study treatment will continue until study doctors decide to stop therapy due to criteria which may include disease progression, adverse events or changes in condition. Participants will be followed for survival health information following treatment until the study ends, which could be approximately 5 years from start of treatment

Primary Outcome Measure

Overall Response Rate in PD-L1 negative melanoma [ Time Frame: 5 Years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02214-

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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