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

NCT04091217 | Completed Phase 2 Results

• 1 other identifier: ML41186
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

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

  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).

  Up to approximately 32 months

Secondary Outcomes (5)

• 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)

Study Arms (1)

Atezolizumab + Bevacizumab

EXPERIMENTAL

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg will be administered intravenously every 3 weeks.

Also known as: Tecentriq

Atezolizumab + Bevacizumab

Bevacizumab DRUG

Bevacizumab 7.5 mg/kg will be administered intravenously every 3 weeks.

Also known as: Avastin

Atezolizumab + Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

You may not qualify if:

• 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
• Prior allogeneic stem cell or solid organ transplantation
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
• Current treatment with anti-viral therapy for HBV
• Current, recent (within 28 days prior to initiation of study treatment) or planned treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 6 months after the final dose of bevacizumab

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Beijing Cancer Center; Renal Cancer And Melanoma Department.

Beijing, 100142, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, 350014, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Related Publications (1)

• Mao L, Fang M, Chen Y, Wei X, Cao J, Lin J, Zhang P, Chen L, Cao X, Chen Y, Guo J, Si L. Atezolizumab plus Bevacizumab in Patients with Unresectable or Metastatic Mucosal Melanoma: A Multicenter, Open-Label, Single-Arm Phase II Study. Clin Cancer Res. 2022 Nov 1;28(21):4642-4648. doi: 10.1158/1078-0432.CCR-22-1528.

  PMID: 36044526 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: November 25, 2019
• Primary Completion: August 31, 2022
• Study Completion: September 1, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)