Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Atezolizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

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

Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks ith 21 consecutive days defined as a treatment cycle.

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

Elizabeth Buchbinder, MD

Elizabeth I Buchbinder, MD

Ryan Joseph Sullivan, MD

David F. McDermott, MD

David F McDermott, MD

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

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.

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary endpoint for this study is overall response rate in PDL1 negative melanoma to combination anti-PD-L1 therapy and anti-VEGF therapy by RECIST criteria. The proportion of patients with complete response or partial response as best response to therapy will be summarized and presented with a two-sided, 90% Wald confidence interval.

Time to tumor progression (TTP) is the time interval between the dates of the start of trial treatment and first documentation of progressive disease

The time-to-event endpoints will each be summarized using the method of KaplanMeier Point estimates for each endpoint will be presented with 90% confidence intervals derived using log(-log(endpoint)) methodology.

Pre-treatment percentages of stromal infiltrating lymphocytes will be summarized descriptively for the two response groups and compared using Wilcoxon rank-sum tests.

Changes in TILs between baseline and progression/treatment discontinuation will be calculated (post-pre) for each patient and summarized descriptivelyChanges in TILs between baseline and progression/treatment discontinuation will be calculated (post-pre) for each patient and summarized descriptively

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma	NCT04356729	Clinical Stage ... Stage IV Melano... Unresectable St... Unresectable St...	Atezolizumab Bevacizumab	18 Years -	Dana-Farber Cancer Institute
A Phase II Trial of PD-L1 Therapy Combined With Anti-VEGF Therapy in Unresectable or Metastatic Melanoma	NCT04356729	Clinical Stage ... Stage IV Melano... Unresectable St... Unresectable St...	Atezolizumab Bevacizumab	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for unresectable stage iii cutaneous melanoma