Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors

NCT03074513 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2016-0861NCI-2017-00501
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well atezolizumab and bevacizumab work in treating patients with rare solid tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions

Human Papillomavirus-Related Anal Squamous Cell Carcinoma; Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis; Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma; Neuroendocrine Carcinoma; Pancreatic Neuroendocrine Tumor; Recurrent Merkel Cell Carcinoma; Recurrent Nasopharynx Carcinoma; Recurrent Peritoneal Malignant Mesothelioma; Recurrent Pleural Malignant Mesothelioma; Stage III Merkel Cell Carcinoma AJCC v7; Stage III Nasopharyngeal Carcinoma AJCC v7; Stage III Pleural Malignant Mesothelioma AJCC v7; Stage IV Merkel Cell Carcinoma AJCC v7; Stage IV Nasopharyngeal Carcinoma AJCC v7; Stage IV Pleural Malignant Mesothelioma AJCC v7; Stage IVA Nasopharyngeal Carcinoma AJCC v7; Stage IVB Nasopharyngeal Carcinoma AJCC v7; Stage IVC Nasopharyngeal Carcinoma AJCC v7; Vaginal Squamous Cell Carcinoma, Not Otherwise Specified; Appendix Adenocarcinoma; Human Papillomavirus-Related Cervical Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response

  Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (modified RECIST for pleural mesothelioma). Will be defined as a complete response or partial response on two consecutive occasions 4 weeks apart as determined by an independent radiologist. For each tumor group, the best response rate and its 95% exact confidence interval will be estimated using the Clopper and Pearson method. The combination treatment will be assessed by performing the independent binomial test comparing the best response rate versus the historical control for each tumor group. The Bayesian classification and information sharing method proposed by Lee and Chen may be applied.

  Up to 4 years

Secondary Outcomes (9)

• Objective response

  Up to 4 years

• Progression free survival

  The time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 4 years

• Duration of response

  The time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, assessed up to 4 years

• Overall survival

  The time from enrollment to death from any cause, assessed up to 4 years

• Progression free survival

  Up to 4 years

Other Outcomes (1)

• Predictive and prognostic biomarkers in blood and tumor tissue

  Up to 4 years

Study Arms (1)

Treatment (atezolizumab, bevacizumab)

EXPERIMENTAL

Patients receive atezolizumab and bevacizumab IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Atezolizumab; Biological: Bevacizumab; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Atezolizumab DRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG7446, RO5541267, Tecentriq

Treatment (atezolizumab, bevacizumab)

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar SCT501, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501

Treatment (atezolizumab, bevacizumab)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (atezolizumab, bevacizumab)

Pharmacological Study OTHER

Correlative studies

Treatment (atezolizumab, bevacizumab)

Eligibility Criteria

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

You may qualify if:

• Signed informed consent form
• Ability to comply with the study protocol, in the investigator's judgment
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation; the pleural mesothelioma cohort will require measurable disease according to modified RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L without granulocyte colony-stimulating factor support, obtained within 14 days prior to initiation of study treatment
• Lymphocyte count \>= 0.5 x 10\^9/L, obtained within 14 days prior to initiation of study treatment
• Platelet count \>= 100 x 10\^9/L without transfusion, obtained within 14 days prior to initiation of study treatment
• White blood cell (WBC) count \>= 2500/ul, obtained within 14 days prior to initiation of study treatment
• Hemoglobin \>= 90 g/L (patients may be transfused to meet this criterion), obtained within 14 days prior to initiation of study treatment
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\< 2.5 x upper limit of normal (ULN), obtained within 14 days prior to initiation of study treatment, with the following exceptions: patients with documented liver metastases: AST and ALT =\< 5 x ULN; patients with documented liver or bone metastases: alkaline phosphatase (ALP) =\< 5 x ULN
• Serum bilirubin 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
• Serum creatinine =\< 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
• Serum albumin \>= 2.5 g/dL, obtained within 14 days prior to initiation of study treatment
• For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\< 1.5 x ULN, obtained within 14 days prior to initiation of study treatment
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

You may not qualify if:

• Treatment for the studied cancer within 28 days prior to initiation of study treatment
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells
• Known allergy or hypersensitivity to any component of the atezolizumab formulation
• Known allergy or hypersensitivity to any component of the bevacizumab formulation
• 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, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study; patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover \< 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• 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
• Prior allogeneic stem cell or solid organ transplantation
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted)
• Positive HIV test at screening (except in cohort 3, HPV-associated cancers)
• Except in cohort 3, HPV-associated cancers, active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study
• Except in cohort 3, HPV-associated cancers active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening; the HCV RNA test will be performed only for patients who have a positive HCV antibody test

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Halperin DM, Liu S, Dasari A, Fogelman D, Bhosale P, Mahvash A, Estrella JS, Rubin L, Morani AC, Knafl M, Overeem TA, Fu SC, Solis LM, Parra Cuentas E, Verma A, Chen HL, Gite S, Subashchandrabose P, Dervin S, Schulze K, Darbonne WC, Yun C, Wistuba II, Futreal PA, Woodman SE, Yao JC. Assessment of Clinical Response Following Atezolizumab and Bevacizumab Treatment in Patients With Neuroendocrine Tumors: A Nonrandomized Clinical Trial. JAMA Oncol. 2022 Jun 1;8(6):904-909. doi: 10.1001/jamaoncol.2022.0212.

  PMID: 35389428 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Adenocarcinoma, Mucinous; Carcinoma, Neuroendocrine; Adenoma, Islet Cell; Carcinoma, Merkel Cell; Nasopharyngeal Neoplasms; Mesothelioma, Malignant; Nasopharyngeal Carcinoma

Interventions

atezolizumab; Bevacizumab; Immunoglobulin G; Disulfides

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Adenoma; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mesothelioma; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Kanwal P Raghav, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 8, 2017
• Study Start: March 3, 2017
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)