A study of a medicine (GDC-0919) combined with another medicine (atezolizumab) in patients with cancer that has grown or spread

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

Cancer
Solid Tumors

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Basic Details

Gender

All

Age

≥18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02471846, GO29779, 2015-001741-88

Researchers wanted to find out what dose of the study medicine (GDC-0919) was safe to combine with another medicine (atezolizumab). Both of these medicines have an effect on the immune system of the patient. The combination treatment was given to cancer patients to find out what effects, good and/or bad, GDC-0919 and atezolizumab had on patients and on their cancers. All patients received the same dose of atezolizumab; GDC-0919 was given at different doses to different groups of patients.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT02471846, GO29779, 2015-001741-88

Condition Solid Tumor

Official Title 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

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study of a medicine (GDC-0919) combined with another medicine (atezolizumab) in patients with cancer that has grown or spread

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study of a medicine (GDC-0919) combined with another medicine (atezolizumab) in patients with cancer that has grown or spread

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com