A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors

Genentech, Inc.610 enrolled

Overview

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

610

Conditions

Neoplasms

Interventions

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy of at least 12 weeks * Adequate hematologic and end organ function * Histologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of care * Tumor specimen availability * Measurable disease according to RECIST v1.1 Exclusion Criteria: * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment * Malignancies other than disease under study within 5 years prior to D1 of C1 * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases * History of leptomeningeal disease * History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted * History of autoimmune disease * Positive human immunodeficiency virus test result * Active hepatitis B, hepatitis C, or tuberculosis * Severe infection within 4 weeks prior to D1 of C1 * Prior allogeneic bone marrow or solid organ transplantation * Significant cardiovascular disease * Known clinically significant liver disease

Locations (27)

HonorHealth Research Institute - Bisgrove

Scottsdale, Arizona, United States

University of Colorado

Aurora, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, United States

University Of Chicago Medical Center; Section Of Hematology/Oncology

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Number of Participants with Dose-Limiting Toxicities (DLTs)

Time frame: Days (D) 1-21 of Cycle (C) 1 (cycle = 21 days); up to D42 if extended monitoring warranted

Number of Participants with Adverse Events Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0

Time frame: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to 3 years)

Secondary Outcomes

Maximum Tolerated Dose (MTD) of MOXR0916

Time frame: Up to 1 year

Recommended Phase II Dose (RP2D) of MOXR0916

Time frame: Up to 1 year

Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies