Solid TumorPhase 1NCT02471846
A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing Atezolizumab and GDC-0919 in people with Solid Tumor, run by Genentech, Inc. at 18 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Atezolizumab and GDC-0919
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 28 Jul 2015to 2 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States10 sites
University of Colorado
Aurora, Colorado, 80045-2517
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
The Angeles Clinic and Research Institute, Santa Monica Office
Santa Monica, California, 90025
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center - Oncology
Seoul, 05505
Samsung Medical Center
Seoul, 6351
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario HM Sanchinarro-CIOCC
Madrid, 28050
Hospital Clinico Universitario de Valencia
Valencia, 46010
France2 sites
Hopital Nord AP-HM
Marseille, 13015
Institut Gustave Roussy
Villejuif, 94805
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- Atezolizumab, GDC-0919
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq, MPDL3280A, RO5541267
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.
GDC-0919Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Atezolizumab; Drug: GDC-0919 |
| Biopsy Cohort B | Experimental | Approximately 20 participants with melanoma, HNSCC, gastric, ovarian, Merkel cell, cervical, or endometrial cancer will receive atezolizumab 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. Receives: Drug: Atezolizumab; Drug: GDC-0919 |
| Dose-Escalation Cohort(s) | Experimental | Approximately 6 to 65 participants will be enrolled and treated at escalating doses of GDC-0919 in combination with fixed-dose atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio. Successive groups of at least 3 participants will be evaluated during a 21-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage. The MTD or MAD, whichever is reached first, will be considered for the expansion stage. Receives: Drug: Atezolizumab; Drug: GDC-0919 |
| Expansion Cohorts | Experimental | Approximately 160 participants (40 per diagnosis) with NSCLC, RCC, TNBC, and UBC 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. Receives: Drug: Atezolizumab; Drug: GDC-0919 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Measured: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Percentage of Participants With Adverse Events
Measured: From Screening until new anti-cancer therapy or up to 60 days after last dose (up to approximately 3 years)
Secondary outcomes (15)
Maximum Tolerated Dose (MTD) of GDC-0919
Measured: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Recommended Phase II Dose (RP2D) for GDC-0919
Measured: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Number of Treatment Cycles Received With GDC-0919 and Atezolizumab
Measured: From Day -1 of Cycle 1 (each cycle is 21 days) until treatment discontinuation (up to approximately 3 years)
Dose Intensity of GDC-0919 and Atezolizumab
Measured: From Day -1 of Cycle 1 (each cycle is 21 days) until treatment discontinuation (up to approximately 3 years)
Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab
Measured: 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)
Plasma Maximum Concentration (Cmax) of GDC-0919
Measured: Post-dose on Day -1 of Cycle 1 (each cycle is 21 days) and Day 1 of Cycle 2
Plasma Minimum Concentration (Cmin) of GDC-0919
Measured: Pre-dose from Day -1 of Cycle 1 (each cycle is 21 days) through Day 1 of Cycle 8
Area Under the Concentration-time Curve to the Last Measurable Concentration (AUC0-last) of GDC-0919
Measured: Pre-dose and post-dose from Day -1 of Cycle 1 (each cycle is 21 days) through Day 1 of Cycle 8
Time to Maximum Concentration (Tmax) of GDC-0919
Measured: Post-dose on Day -1 of Cycle 1 (each cycle is 21 days) and Day 1 of Cycle 2
Serum Cmax of Atezolizumab
Measured: 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)
Serum Cmin of Atezolizumab
Measured: Pre-dose from Day 1 of Cycle 1 up to 120 days after last dose of atezolizumab (up to approximately 3 years)
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
Measured: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Duration of Objective Response According to RECIST v1.1 as Determined by the Investigator
Measured: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Percentage of Participants With Objective Response According to Modified RECIST as Determined by the Sponsor
Measured: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Duration of Objective Response According to Modified RECIST as Determined by the Sponsor
Measured: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start28 Jul 2015
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471846
- Sponsor's protocol ID
- GO29779
- Other IDs
- 2015-001741-88, 2015
- Status last verified
- Oct 2019
- First submitted
- 4 Jun 2015
- Last updated
- 22 Oct 2019
- Results posted
- No
Publications
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.
PubMed 30770348
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02471846
- Acronym / sponsor ID
- GO29779
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Anti-PD-1/PD-L1 Relapsed Cohort I | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 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. |
| Anti-PD-1/PD-L1 Relapsed Cohort II | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 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. |
| Biopsy Cohort A | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 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. |
| Biopsy Cohort B | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 20 participants with melanoma, HNSCC, gastric, ovarian, Merkel cell, cervical, or endometrial cancer will receive atezolizumab 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. |
| Dose-Escalation Cohort(s) | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 6 to 65 participants will be enrolled and treated at escalating doses of GDC-0919 in combination with fixed-dose atezolizumab. Treatment may continue until unacceptable toxicity or disease progression with an unfavorable risk-benefit ratio. Successive groups of at least 3 participants will be evaluated during a 21-day window for DLTs, which will determine the enrollment and dosing for subsequent cohorts in the dose-escalation stage. The MTD or MAD, whichever is reached first, will be considered for the expansion stage. |
| Expansion Cohorts | Experimental | Drug: Atezolizumab, Drug: GDC-0919Approximately 160 participants (40 per diagnosis) with NSCLC, RCC, TNBC, and UBC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: Tecentriq, MPDL3280A, RO5541267Participants 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. | Drug | Anti-PD-1/PD-L1 Relapsed Cohort I, Anti-PD-1/PD-L1 Relapsed Cohort II, Biopsy Cohort A, Biopsy Cohort B, Dose-Escalation Cohort(s), Expansion Cohorts |
| GDC-0919Participants 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. | Drug | Anti-PD-1/PD-L1 Relapsed Cohort I, Anti-PD-1/PD-L1 Relapsed Cohort II, Biopsy Cohort A, Biopsy Cohort B, Dose-Escalation Cohort(s), Expansion Cohorts |
Primary outcome
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
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)
15 secondary outcomes
Maximum Tolerated Dose (MTD) of GDC-0919
Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
Recommended Phase II Dose (RP2D) for GDC-0919
Time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)
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)
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)
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)
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
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
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
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
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 30770348Jung 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.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atezolizumab and GDC-0919 in people with Solid Tumor, run by Genentech, Inc. at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, South Korea, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Dose-limiting Toxicities (DLTs) (time frame: From Day -1 to 21 of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.