Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

Hoffmann-La Roche3 sites in 1 country43 target enrollmentNovember 25, 2019

ConditionsMelanoma

InterventionsAtezolizumab Bevacizumab

Overview

Phase: Phase 2
Intervention: Atezolizumab
Conditions: Melanoma
Sponsor: Hoffmann-La Roche
Enrollment: 43
Locations: 3
Primary Endpoint: Objective Response Rate (ORR) in the Full Analysis Set Analysis Population
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab in patients with unresectable locally advanced or metastatic mucosal melanoma.

Detailed Description

The study is divided into 2 stages. Stage I of the study is completed when 22 patients with measurable disease have been enrolled and completed ORR evaluation. If the number of responders in Stage I is more than 3, another 16 patients may be enrolled to Stage II.

Registry

clinicaltrials.gov

Start Date

November 25, 2019

End Date

September 1, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed unresectable locally advanced(stage III) or metastatic(Stage IV) mucosal melanoma
•May have received prior systemic treatment or treatment naive at enrollment
•Measurable disease per RECIST v1.1
•ECOG Performance Status of 0-1
•Life expectancy \>= 12 weeks
•Adequate hematologic and end-organ function
•Negative HIV test at screening
•Negative hepatitis B surface antigen test at screening
•Negative hepatitis B core antibody at screening, or positive total HBcAb test followed by quantitative hepatitis B virus DNA\<500 IU/mL at screening.
•Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening

Exclusion Criteria

•Symptomatic or actively progressing central nervous system (CNS) metastases
•History of leptomeningeal disease
•Uncontrolled tumor-related pain
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•Uncontrolled or symptomatic hypercalcemia
•Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: 1) Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. 2) Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. 3) Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: (i) Rash must cover \< 10% of body surface area (ii) Disease is well controlled at baseline and requires only low-potency topical corticosteroids (iii) No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
•Active tuberculosis
•Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
•History of malignancy other than melanoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Arms & Interventions

Atezolizumab + Bevacizumab

Intervention: Atezolizumab

Atezolizumab + Bevacizumab

Intervention: Bevacizumab

Outcomes

Primary Outcomes

Objective Response Rate (ORR) in the Full Analysis Set Analysis Population

Time Frame: Up to approximately 32 months

ORR was defined as the percentage of participants with a complete response (CR) defined as disappearance of all target lesions, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR, on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Secondary Outcomes

Progression-Free Survival (PFS)(Up to approximately 32 months)
Overall Survival (OS)(Up to approximately 32 months)
Duration of Objective Response (DOR)(Up to approximately 32 months)
Disease Control Rate (DCR)(Up to approximately 32 months)
Percentage of Participants With Adverse Events(From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months))