NCT04356729

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Elizabeth Buchbinder, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved atezolizumab for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has not approved bevacizumab for this specific disease but it has been approved for other uses. Atezolizumab and bevacizumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells and stop the growth of cancer. Atezolizumab and bevacizumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer.

Conditions

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

Interventions

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

Timeline

• Start date: 2020-08-06
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2020-04-22
• Last updated: 2025-06-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study