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Completed

NCT Number: NCT02471846

A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hopital Nord AP-HM, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle with the exception of biopsy cohort A, where atezolizumab administration will start on Cycle 2 Day 1.

Other names: Tecentriq, MPDL3280A, RO5541267

GDC-0919

Drug

Participants will receive GDC-0919 by mouth (PO) twice daily (BID), specifically every 12 hours. During the dose-escalation stage, the first cohort will receive GDC-0919 at a starting dose of 50 mg PO BID. Dosing will commence on Day -1 for Cycle 1 and follow subsequent 21-day (Days 1 to 21) dosing cycles. The dose will be modified based upon evaluation of DLTs, with single dose escalations not to exceed 2.5-fold of the previous dose. The proposed dosages for evaluation are 50, 100, 200, 400, 600, and 1000 mg PO BID. During the expansion stage, selected solid tumor types will be treated at the MTD or MAD as determined during the dose-escalation stage.

Primary outcomes

  1. Percentage of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)

  2. Percentage of Participants With Adverse Events

    Time frame: From Screening until new anti-cancer therapy or up to 60 days after last dose (up to approximately 3 years)

Secondary outcomes

  1. Maximum Tolerated Dose (MTD) of GDC-0919

    Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)

  2. Recommended Phase II Dose (RP2D) for GDC-0919

    Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)

  3. Number of Treatment Cycles Received With GDC-0919 and Atezolizumab

    Time frame: From Day -1 of Cycle 1 (each cycle is 21 days) until treatment discontinuation (up to approximately 3 years)

  4. Dose Intensity of GDC-0919 and Atezolizumab

    Time frame: From Day -1 of Cycle 1 (each cycle is 21 days) until treatment discontinuation (up to approximately 3 years)

  5. Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab

    Time frame: Pre-dose from Day 1 of Cycle 1 (each cycle is 21 days) up to 120 days after last dose of atezolizumab (up to approximately 3 years)

  6. Plasma Maximum Concentration (Cmax) of GDC-0919

    Time frame: Post-dose on Day -1 of Cycle 1 (each cycle is 21 days) and Day 1 of Cycle 2

  7. Plasma Minimum Concentration (Cmin) of GDC-0919

    Time frame: Pre-dose from Day -1 of Cycle 1 (each cycle is 21 days) through Day 1 of Cycle 8

  8. Area Under the Concentration-time Curve to the Last Measurable Concentration (AUC0-last) of GDC-0919

    Time frame: Pre-dose and post-dose from Day -1 of Cycle 1 (each cycle is 21 days) through Day 1 of Cycle 8

  9. Time to Maximum Concentration (Tmax) of GDC-0919

    Time frame: Post-dose on Day -1 of Cycle 1 (each cycle is 21 days) and Day 1 of Cycle 2

  10. Serum Cmax of Atezolizumab

    Time frame: Post-dose from Day 1 of Cycle 1 (each cycle is 21 days) up to 120 days after last dose of atezolizumab (up to approximately 3 years)

  11. Serum Cmin of Atezolizumab

    Time frame: Pre-dose from Day 1 of Cycle 1 up to 120 days after last dose of atezolizumab (up to approximately 3 years)

  12. Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator

    Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)

  13. Duration of Objective Response According to RECIST v1.1 as Determined by the Investigator

    Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)

  14. Percentage of Participants With Objective Response According to Modified RECIST as Determined by the Sponsor

    Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)

  15. Duration of Objective Response According to Modified RECIST as Determined by the Sponsor

    Time frame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2015
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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