Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Carcinoma

Carcinoma, Neuroendocrine

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Mesothelioma

Mesothelioma, Malignant

Carcinoma, Merkel Cell

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

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Neuroectodermal Tumors

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Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Communicable Diseases

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Neuroendocrine Tumor

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Penile Cancer

Pancreatic Neuroendocrine Tumor

Adenocarcinoma of the Appendix

Merkel Cell Carcinoma

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Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Atezolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Immune Checkpoint Inhibitors

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.

Laboratory Biomarker Analysis

Pharmacological Study

Daniel M Halperin, MD

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.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of atezolizumab when given in combination with bevacizumab (atezo bev).

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of atezo bev. II. To evaluate the safety of atezo + bev.

EXPLORATORY BIOMARKER OBJECTIVES:

I. To identify biomarkers that are predictive of response to atezo bev (i.e., predictive biomarkers), are associated with progression to a more severe disease state (i.e., prognostic biomarkers), are associated with resistance to atezo bev, are associated with susceptibility to developing adverse events, can provide evidence of study treatment activity, or can increase the knowledge and understanding of disease biology.

OUTLINE:

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

After completion of study treatment, patients are followed up every 3 months.

Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors

A Phase II, Single-Arm Open-Label Study of the Combination of Atezolizumab and Bevacizumab in Rare Solid Tumors

The relationship between biomarkers in blood and tumor tissue and efficacy, safety, pharmacokinetics, immunogenicity, or other biomarker endpoints will be assessed. Summary statistics for biomarkers and their corresponding changes (or percent changes) from baseline will be tabulated by planned study day and dose in each tumor group. The time-course of biomarker measures will be investigated graphically. If there is indication of meaningful pattern over time, further analysis (eg, by linear mixed model) may be performed to characterize the relationship. Methods such as, but not limited to, logistic regression will be used to explore possible associations between biomarker measures and clinical outcomes.

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.

Will be assessed by immune-modified RECIST

Will be assessed by RECIST 1.1 (modified RECIST for pleural mesothelioma). Will be estimated using Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be assessed by RECIST 1.1 (modified RECIST for pleural mesothelioma). For each tumor group the median duration of response and corresponding 2-sided 95% confidence interval will be reported.

Will be estimated using Kaplan-Meier method. The log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model may be utilized to include multiple covariates in the time-to-event analysis.

Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Verbatim adverse events and severity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The safety analyses will include all patients who received at least one dose of study treatment. Toxicity data will be summarized by frequency tables for each tumor type group. The association between the types and severity of toxicity and the tumor group will be evaluated. No formal statistical testing will be performed on these summary.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors	NCT03074513	Appendix Adenoc... Human Papilloma... Human Papilloma... Human Papilloma... Human Papilloma... Neuroendocrine ... Pancreatic Neur... Recurrent Merke... Recurrent Nasop... Recurrent Perit... Recurrent Pleur... Stage III Merke... Stage III Nasop... Stage III Pleur... Stage IV Merkel... Stage IV Nasoph... Stage IV Pleura... Stage IVA Nasop... Stage IVB Nasop... Stage IVC Nasop... Vaginal Squamou...	Atezolizumab Bevacizumab Laboratory Biom... Pharmacological...	18 Years -	M.D. Anderson Cancer Center
Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors	NCT03074513	Appendix Adenoc... Human Papilloma... Human Papilloma... Human Papilloma... Human Papilloma... Neuroendocrine ... Pancreatic Neur... Recurrent Merke... Recurrent Nasop... Recurrent Perit... Recurrent Pleur... Stage III Merke... Stage III Nasop... Stage III Pleur... Stage IV Merkel... Stage IV Nasoph... Stage IV Pleura... Stage IVA Nasop... Stage IVB Nasop... Stage IVC Nasop... Vaginal Squamou...	Atezolizumab Bevacizumab Laboratory Biom... Pharmacological...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage iv pleural malignant mesothelioma ajcc v7