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

  • Solid Tumors
Trial Status:

Completed

This trial runs in
Cities
  • Aurora
  • Baltimore
  • Barcelona
  • Boston
  • Madrid
  • Marseille
  • Nashville
  • New Haven
  • New York
  • Santa Monica
  • Scottsdale
  • Seoul
  • Tampa
  • València
  • Villejuif
Trial Identifier:

NCT02471846 2015-001741-88 GO29779

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02471846 , GO29779 , 2015-001741-88 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      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.

      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT02471846 , GO29779 , 2015-001741-88 Trial Identifier
      Atezolizumab, GDC-0919 Treatments
      Solid Tumor Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No 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

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