A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma (NCT04356729)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (56 items).
Location: Dana Farber Cancer Institute — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants with symptomatic, untreated, or actively progressing CNS metastases will be excluded. If a participant has a known history of treated CNS lesions, they are eligible provided that all of the following criteria are met:
- Measurable disease, per RECIST v1.1, must be present outside the CNS.
- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
- Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
- There is no evidence of interim progression between completion of CNS-directed therapy and the screening brain scan
- The participant has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
- The participant has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. Asymptomatic patients with CNS metastases newly detected at screening are eligible for the study after receiving radiotherapy or surgery, with no need to repeat the screening brain scan.
- History of leptomeningeal disease.
- Uncontrolled tumor-related pain.
- NOTE: Participants requiring pain medication must be on a stable regimen at study entry.
- Symptomatic lesions amendable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment. Participants should be recovered from the effects of radiation. There is no required minimum recovery period.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Dana Farber Cancer Institute — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Clinical Stage III Cutaneous Melanoma AJCC v8
- Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma — Houston, Texas
- Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types — Rochester, Minnesota
- Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors — Nashville, Tennessee
- Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors — Houston, Texas
- Diet and Immune Effects Trial: DIET- A Randomized Double Blinded Dietary Intervention Study in Patients With Metastatic Melanoma Receiving Immunotherapy — Houston, Texas
Explore by condition: All Clinical Stage III Cutaneous Melanoma AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.