A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 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 is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.

Key facts

Study ID

NCT02471846

Run by

Genentech, Inc.

People needed

158

Starts

2015-07-28

Expected to finish

2019-10-02

Last updated by the study team

2019-10-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy at least 12 weeks
• Adequate hematologic and end organ function
• Negative pregnancy test and willingness to utilize contraception among women of childbearing potential
• Locally advanced, recurrent, or metastatic incurable solid malignancy with measurable disease per RECIST v1.1
• Progression following at least one standard therapy; or standard therapy considered ineffective, intolerable, or inappropriate; or use of an investigational agent recognized as a standard of care
• For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer
• For the expansion stage, evaluable for PD-L1 expression
• Anti PD-1/PD-L1 relapsed cohorts (I and II), participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade will be enrolled

You may not qualify if…

• Significant cardiovascular or liver disease
• Major surgery within 28 days of study drug
• Any anti-cancer therapy within 3 weeks of study drug
• Malabsorption syndrome or poor upper gastrointestinal integrity
• Primary central nervous system (CNS) malignancy or active metastases within 5 years
• Uncontrolled tumor pain
• Autoimmune disease other than stable hypothyroidism or vitiligo
• Human immunodeficiency virus (HIV), active hepatitis B or C, or tuberculosis
• Signs/symptoms of infection, or use of antibiotics within 2 weeks of study drug
• Live attenuated vaccine within 4 weeks of study drug
• Known history or predisposition to QT interval prolongation
• Prior cancer immunotherapy, specifically indoleamine 2,3-dioxygenase (IDO) or tryptophan 2,3-dioxygenase (TDO) inhibitors, T-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants

Where it is running

• HonorHealth Research Institute - Bisgrove — Scottsdale, Arizona, United States
• The Angeles Clinic and Research Institute, Santa Monica Office — Santa Monica, California, United States
• University of Colorado — Aurora, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Hopital Nord AP-HM — Marseille, France
• Institut Gustave Roussy — Villejuif, France
• Seoul National University Hospital — Seoul, South Korea
• Asan Medical Center - Oncology — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Universitario HM Sanchinarro-CIOCC — Madrid, Spain
• Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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