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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02794571
Registration number
NCT02794571
Ethics application status
Date submitted
6/06/2016
Date registered
9/06/2016
Date last updated
24/05/2024
Titles & IDs
Public title
Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors
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Scientific title
A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors
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Secondary ID [1]
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2016-000944-33
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Secondary ID [2]
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GO30103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced/Metastatic Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Etoposide
Treatment: Drugs - Capecitabine
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Pembrolizumab
Experimental: Phase Ia Dose-Escalation Stage: Tiragolumab - Cohorts of at least 3 participants each will be treated with escalating doses of tiragolumab.
Experimental: Phase Ia Dose-Expansion Stage: Tiragolumab - Participants will be treated with tiragolumab at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study.
Experimental: Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab - A minimum of 3 participants will be treated for each dose level of tiragolumab in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Experimental: Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab - Participants will be treated every 3 weeks (Q3W) with tiragolumab at or below the MTD or MAD in combination with a fixed dose of atezolizumab with tiragolumab being administered prior to atezolizumab.
Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A - In Cohort A, carboplatin or cisplatin and pemetrexed chemotherapy will be administered after atezolizumab and tiragolumab intravenous (IV) infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin and pemetrexed on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab in combination with pemetrexed on Day 1 of each 21-day cycle.
Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B - In Cohort B, carboplatin and paclitaxel chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin and paclitaxel on Day 1 of each 21-day cycle for 4 to 6 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle (participants enrolled under protocol version 4) or Day 1 of each 28-day cycle (participants enrolled under protocol version 5).
Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C - In Cohort C, carboplatin or cisplatin and etoposide chemotherapy will be administered after atezolizumab and tiragolumab IV infusion. During induction phase, participants will receive atezolizumab and tiragolumab in combination with carboplatin or cisplatin on Day 1 of each 21-day cycle and etoposide on Day 1 to 3 of each 21-day cycle for 4 cycles. During maintenance phase, participants will receive atezolizumab and tiragolumab on Day 1 of each 28-day cycle.
Experimental: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D - In Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.
Experimental: Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab - Participants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab.
Experimental: Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab - Participants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag.
Experimental: Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1 - In Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.
Experimental: Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2 - In Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle.
Treatment: Drugs: Atezolizumab
Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle.
Treatment: Drugs: Tiragolumab
Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and/or other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and/or other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit.
Treatment: Drugs: Carboplatin
Carboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion.
Treatment: Drugs: Cisplatin
Cisplatin 75 milligram per square meter (mg/m^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
Treatment: Drugs: Pemetrexed
Pemetrexed 500 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab.
Treatment: Drugs: Paclitaxel
Paclitaxel 200 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab.
Treatment: Drugs: Etoposide
Etoposide 100 mg/m^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab.
Treatment: Drugs: Capecitabine
Capecitabine 1250 mg/m^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.
Treatment: Drugs: Bevacizumab
Bevacizumab 15 mg/kg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
Treatment: Drugs: Pembrolizumab
Pembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Dose-Limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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From Baseline to the end of Cycle 1 (up to 21 days)
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Primary outcome [2]
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Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0
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Assessment method [2]
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Timepoint [2]
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From Baseline up to 90 days after last dose of study treatment or until initiation of another systemic anti-cancer therapy (up to approximately 8 years)
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Primary outcome [3]
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Number of Cycles with Tiragolumab
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Assessment method [3]
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Timepoint [3]
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From Baseline to last dose (up to approximately 8 years)
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Primary outcome [4]
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Phase Ia and Ib: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Tiragolumab
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Assessment method [4]
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Phase (Ph) 1a: Pre-dose on Day 1, Cycles 1-4, 8, 16, every eight cycles (Q8C), at discontinuation (DC), every 30 days up to 120 days (cycle length 21 days); Phase 1b without Chemotherapy: Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, DC (cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (cycle length 21/28 days).
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Timepoint [4]
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Day 1 up to 8 years
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Primary outcome [5]
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Phase Ib: Percentage of Participants with ADAs to Atezolizumab
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Assessment method [5]
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Phase 1b (without Chemotherapy): Pre-dose on Day 1, Cycles 1-4, 8, then Q8C, at DC, every 30 days up to 120 days (cycle length 21 days); Phase 1b (Chemotherapy Cohorts and Q4W): Pre-dose on Day 1, Cycles 1-4, 8, 12 and 16, then DC (cycle length 21/28 days).
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Timepoint [5]
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Day 1 up to 8 years
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Secondary outcome [1]
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Area Under the Concentration-Time Curve (AUC) of Tiragolumab
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Assessment method [1]
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During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; Ph1a and 1b - Q8C, DC; every 30 days up to 120 days.
During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
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Timepoint [1]
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Day 1 up to 8 years
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Secondary outcome [2]
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Maximum Serum Concentration (Cmax) of Tiragolumab
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Assessment method [2]
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During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 h post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.
During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
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Timepoint [2]
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Day 1 up to 8 years
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Secondary outcome [3]
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Minimum Serum Concentration (Cmin) of Tiragolumab
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Assessment method [3]
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During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.
During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 h post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
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Timepoint [3]
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Day 1 up to 8 years
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Secondary outcome [4]
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Clearance (CL) of Tiragolumab
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Assessment method [4]
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During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.
During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
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Timepoint [4]
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Day 1 up to 8 years
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Secondary outcome [5]
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Volume of Distribution at Steady State (Vss) of Tiragolumab
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Assessment method [5]
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During Phase Ia and Phase Ib dose-escalation stages time frame is as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2-7 (Ph 1a), Cycles 2, 3, 4 ,8, 16 -0.5 hour post-dose; ph1a and 1b - Q8C, DC; every 30 days up to 120 days.
During Phase Ia dose-expansion stage and Phase Ib dose-expansion stages with and without chemotherapy time frame is as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21/28 days); Cycle 1: Post-dose-0.5 hour, Days 2, 8 and 15 (D2, D8 and D15 only applicable to Q4W co-infusion cohort); Day 1, Cycles 2, 3, 4, 8, 12* 16 (C12* only applicable to Q4W and Chemotherapy cohorts): 0.5 hour post-dose; ph1a and 1b (Q3W)- Q8C, DC; every 30 days up to 120 days.
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Timepoint [5]
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Day 1 up to 8 years
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Secondary outcome [6]
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Cmax of Atezolizumab
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Assessment method [6]
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During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1,Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 hour post-dose; Q8C, DC; every 30 days up to 120 days.
During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles (cycle length 21/28 days) 1-4, 8, 12*, 16 (C12* only applicable to Q4W and Chemotherapy cohorts); Post-dose 0.5 hour on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days. For Q4W co-infusion cohort only: post-dose Days 2, 8 and 15 of Cycle 1.
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Timepoint [6]
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Day 1 up to 8 years
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Secondary outcome [7]
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Cmin of Atezolizumab
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Assessment method [7]
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During Phase Ib dose-escalation stage time frame will be as follows: Pre-dose Day 1, Cycles 1-4, 8 (cycle length 21 days); Cycle 1: Post-dose-0.5 hour, 24 hours, Days 8 and 15; Day 1, Cycles 2 ,3, 4, 8, 16: 0.5 hour post-dose; Q8C, DC; every 30 days up to 120 days.
During Phase Ib dose-expansion stages time frame will be as follows: Pre-dose on Day 1 of Cycles (cycle length 21/28 days) 1-4,8, 12*, 16 (C12* only applicable to Q4W and Chemotherapy cohorts); Post-dose 0.5 hour on Day 1 of Cycles 1-4, 8, 12, 16; then Q8C until/at DC, every 30 days up to 120 days. For Q4W co-infusion cohort only: post-dose Days 2, 8 and 15 of Cycle 1.
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Timepoint [7]
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Day 1 up to 8 years
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Secondary outcome [8]
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Plasma Concentration of Cisplatin
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Assessment method [8]
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Timepoint [8]
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Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
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Secondary outcome [9]
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Plasma Concentration of Carboplatin
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Assessment method [9]
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0
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Timepoint [9]
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Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
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Secondary outcome [10]
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Plasma Concentration of Pemetrexed
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Assessment method [10]
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Timepoint [10]
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Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
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Secondary outcome [11]
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Plasma Concentration of Paclitaxel
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Assessment method [11]
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0
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Timepoint [11]
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Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
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Secondary outcome [12]
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Plasma Concentration of Etoposide
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Assessment method [12]
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0
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Timepoint [12]
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Pre-dose (5 min) and post-dose (1 hour) on Day 1 of Cycles 1 and 3 (cycle length 21 days)
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Secondary outcome [13]
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Plasma Concentration of Capecitabine
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Assessment method [13]
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0
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Timepoint [13]
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Pre-dose (5 min) on Day 1 of Cycle 1 and post-dose (2 hours) on Day 1 of Cycle 3 (cycle length 21 days)
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Secondary outcome [14]
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Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Assessment method [14]
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0
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Timepoint [14]
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From Baseline until disease progression (up to 8 years)
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Secondary outcome [15]
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Duration of Objective Response (DOR) According to RECIST Version 1.1
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Assessment method [15]
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Timepoint [15]
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From Baseline until disease progression (up to 8 years)
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Secondary outcome [16]
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Progression-Free Survival (PFS) According to RECIST Version 1.1
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Assessment method [16]
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Timepoint [16]
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From Baseline until disease progression (up to 8 years)
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Secondary outcome [17]
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Overall survival (OS) According to RECIST Version 1.1
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Assessment method [17]
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Timepoint [17]
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Baseline until death from any cause (up to approximately 8 years)
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Eligibility
Key inclusion criteria
- Adults 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 12 weeks
- Adequate hematologic and end organ function
- Histologic documentation of locally advanced, recurrent, or metastatic incurable
malignancy that has progressed after at least one available standard therapy; or for
which standard therapy has proven ineffective, intolerable, or considered
inappropriate; or for which a clinical trial of an investigational agent is a
recognized standard of care
- Confirmed availability of representative tumor specimens
- Measurable disease according to RECIST Version 1.1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy,
hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study
treatment
- Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
- Leptomeningeal disease
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or
evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
- History of autoimmune disease
- Positive human immunodeficiency virus (HIV) test
- Active hepatitis B or C, or tuberculosis
- Severe infection within 4 weeks prior to randomization
- Prior allogeneic bone marrow or solid organ transplant
- Significant cardiovascular disease
- Known clinically significant liver disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/10/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
518
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Kinghorn Cancer Centre; St Vincents Hospital - Darlinghurst
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Recruitment hospital [2]
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Peter MacCallum Cancer Center - North Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3051 - North Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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Connecticut
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0
0
United States of America
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State/province [4]
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Maryland
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0
0
United States of America
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State/province [5]
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Massachusetts
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0
0
United States of America
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State/province [6]
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Michigan
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Country [7]
0
0
United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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Tennessee
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Country [9]
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Canada
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State/province [9]
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Ontario
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Country [10]
0
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France
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State/province [10]
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Bordeaux
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Country [11]
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France
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State/province [11]
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Lyon
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France
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State/province [12]
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Paris
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Country [13]
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France
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State/province [13]
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Toulouse
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France
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State/province [14]
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Villejuif
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0
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Japan
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State/province [15]
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Tokyo
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Country [16]
0
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Korea, Republic of
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State/province [16]
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Seoul
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Country [17]
0
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Spain
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State/province [17]
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Barcelona
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Country [18]
0
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Spain
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State/province [18]
0
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Navarra
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Country [19]
0
0
Spain
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State/province [19]
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Madrid
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Country [20]
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Spain
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State/province [20]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genentech, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This first-in-human open-label, multicenter, dose-escalation and expansion study is designed
to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with
atezolizumab and/or other anti-cancer therapies in participants with locally advanced,
recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has
proven to be ineffective or intolerable, or is considered inappropriate, or for whom a
clinical trial of an investigational agent is a recognized standard of care.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02794571
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02794571
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