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Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors

Neuroendocrine Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Appendix Adenocarcinoma
  • Carcinoma
  • Carcinoma, Merkel Cell
  • Carcinoma, Neuroendocrine
  • Carcinoma, Squamous Cell
  • Human Papillomavirus-Related Anal Squamous Cell Carcinoma
  • Human Papillomavirus-Related Cervical Squamous Cell Carcinoma
  • Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis
  • Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma
  • Lung Neoplasms
  • Mesothelioma
  • Mesothelioma, Malignant
  • Nasopharyngeal Carcinoma
  • Neuroendocrine Carcinoma
  • Neuroendocrine Tumors
  • Pancreatic Neuroendocrine Tumor
  • Recurrence
  • 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
Clinical Trial Details
NCT number NCT03074513
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 3, 2017
Completion date June 30, 2024
View Details
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