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



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/26/2019
Start Date:July 28, 2015
End Date:December 31, 2019

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A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0919 Administered With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
12
sites
8850 East Pima Center Parkway
Scottsdale, Arizona 85258
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Aurora, Colorado 80045
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Marseille, 13015
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Marseille,
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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11818 Wilshire Boulevard
Santa Monica, California 90025
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Santa Monica, CA
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Tampa, FL
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