A Study of GDC-0919 and Atezolizumab Combination Treatmen... | NCT02471846

ID	Type	Description	Link
2015-001741-88	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anti-PD-1/PD-L1 Relapsed Cohort I	Experimental	Approximately 20 participants whose most recent anti-cancer therapy consisted of single-agent programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) blockade and achieved best response of confirmed complete or partial response, or stable disease will receive GDC-0919, at the MTD or maximum administered dose (MAD) determined during the dose-escalation stage, in combination with atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.	Drug: Atezolizumab Drug: GDC-0919
Anti-PD-1/PD-L1 Relapsed Cohort II	Experimental	Approximately 20 participants whose most recent anti-cancer therapy consisted of single-agent PD-1/PD-L1 blockade and achieved unconfirmed partial response or stable disease will receive GDC-0919, at the MTD or MAD determined during the dose-escalation stage, in combination with atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.	Drug: Atezolizumab Drug: GDC-0919
Biopsy Cohort A	Experimental	Approximately 20 participants with melanoma, HNSCC, gastric, ovarian, Merkel cell, cervical, or endometrial cancer will receive GDC-0919 during Cycle 1, followed by combination treatment with GDC-0919 and atezolizumab from Cycle 2 onwards. Serial biopsies of extrahepatic lesions will be performed. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio.	Drug: Atezolizumab Drug: GDC-0919
Biopsy Cohort B

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Dose-limiting Toxicities (DLTs)		From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Percentage of Participants With Adverse Events		From Screening until new anti-cancer therapy or up to 60 days after last dose (up to approximately 3 years)

Secondary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD) of GDC-0919		From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Recommended Phase II Dose (RP2D) for GDC-0919		From Day -1 to 21 of Cycle 1 (each cycle is 21 days)

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
HonorHealth Research Institute - Bisgrove		Scottsdale	Arizona	85258	United States
The Angeles Clinic and Research Institute, Santa Monica Office

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30770348	Derived	Jung KH, LoRusso P, Burris H, Gordon M, Bang YJ, Hellmann MD, Cervantes A, Ochoa de Olza M, Marabelle A, Hodi FS, Ahn MJ, Emens LA, Barlesi F, Hamid O, Calvo E, McDermott D, Soliman H, Rhee I, Lin R, Pourmohamad T, Suchomel J, Tsuhako A, Morrissey K, Mahrus S, Morley R, Pirzkall A, Davis SL. Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors. Clin Cancer Res. 2019 Jun 1;25(11):3220-3228. doi: 10.1158/1078-0432.CCR-18-2740. Epub 2019 Feb 15.

ID	Term
C000594389	atezolizumab
C000655606	navoximod