← Back to Search

Monoclonal Antibodies

Tiragolumab + Atezolizumab/Other Therapies for Cancer

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline until disease progression (up to 8 years)

Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of the drug tiragolumab, either alone or in combination with atezolizumab, in people with cancer for whom standard therapy does not exist, is ineffective, or is intolerable.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic cancer that's worsened after standard treatment, or when such treatments aren't suitable. They should be relatively healthy (ECOG 0-1), have a life expectancy of at least 12 weeks, and measurable disease. People with severe lung conditions, active hepatitis B/C or tuberculosis, autoimmune diseases, HIV, significant liver disease or heart problems can't join.Check my eligibility

What is being tested?

The study tests Tiragolumab alone or combined with Atezolizumab and/or other anti-cancer drugs in patients whose tumors have not responded to standard therapies. It's an early-stage trial to check the safety and how the body processes these drugs at different doses.See study design

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, infusion-related symptoms similar to allergic reactions, fatigue from treatment burden on the body, potential blood abnormalities due to bone marrow suppression by chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until disease progression (up to 8 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline until disease progression (up to 8 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until disease progression (up to 8 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Cycles with Tiragolumab

Percentage of Participants with Adverse Events (AEs) Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0

Percentage of Participants with Dose-Limiting Toxicities (DLTs)

+2 more

Secondary outcome measures

Area Under the Concentration-Time Curve (AUC) of Tiragolumab

Clearance (CL) of Tiragolumab

Cmax of Atezolizumab

+14 more

Trial Design

12Treatment groups

Experimental Treatment

Group I: Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+AtezolizumabExperimental Treatment2 Interventions

Participants will be treated every 4 weeks (Q4W) with fixed doses of tiragolumab and atezolizumab with tiragolumab being administered prior to atezolizumab.

Group II: Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+AtezolizumabExperimental Treatment2 Interventions

Participants will be treated Q4W with fixed doses of tiragolumab and atezolizumab mixed and administered in one IV bag.

Group III: Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+AtezolizumabExperimental Treatment2 Interventions

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.

Group IV: Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+AtezolizumabExperimental Treatment2 Interventions

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.

Group V: Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2Experimental Treatment2 Interventions

In Cohort NC2, participants will receive tiragolumab in combination with pembrolizumab on Day 1 of each 21-day cycle.

Group VI: Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1Experimental Treatment3 Interventions

In Cohort NC1, participants will receive atezolizumab and tiragolumab in combination with bevacizumab on Day 1 of each 21-day cycle.

Group VII: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort DExperimental Treatment3 Interventions

In Cohort D, participants will receive atezolizumab and tiragolumab on Day 1 and capecitabine on Day 1-14 of each 21-day cycle.

Group VIII: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort CExperimental Treatment5 Interventions

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.

Group IX: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort BExperimental Treatment4 Interventions

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).

Group X: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort AExperimental Treatment5 Interventions

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.

Group XI: Phase Ia Dose-Expansion Stage: TiragolumabExperimental Treatment1 Intervention

Participants will be treated with tiragolumab at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD) in the study.

Group XII: Phase Ia Dose-Escalation Stage: TiragolumabExperimental Treatment1 Intervention

Cohorts of at least 3 participants each will be treated with escalating doses of tiragolumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Bevacizumab

2013

Completed Phase 4

~5280

Tiragolumab

2020

Completed Phase 2

~350

Cisplatin

2013

Completed Phase 3

~1940

Etoposide

2010

Completed Phase 3

~2440

Capecitabine

2013

Completed Phase 3

~3420

Atezolizumab

2017

Completed Phase 3

~5860

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

Paclitaxel

2011

Completed Phase 4

~5380

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,171 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,984 Total Patients Enrolled

Media Library

Cancer Research Study Groups: Phase Ib Chemotherapy Dose-Expansion Stage: Cohort A, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort D, Phase Ib Q4W Sequential Dose-Expansion Stage: Tiragolumab+Atezolizumab, Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC2, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort C, Phase Ib Chemotherapy Dose-Expansion Stage: Cohort B, Phase Ia Dose-Escalation Stage: Tiragolumab, Phase Ia Dose-Expansion Stage: Tiragolumab, Phase Ib Q3W Dose-Escalation Stage: Tiragolumab+Atezolizumab, Phase Ib Q3W Dose-Expansion Stage: Tiragolumab+Atezolizumab, Phase Ib Q4W Coinfusion Expansion Cohort Tiragolumab+Atezolizumab, Phase Ib Non-Chemotherapy Dose-Expansion Stage: Cohort NC1

Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT02794571 — Phase 1

Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02794571 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What findings have other researchers gleaned from experimentation with Tiragolumab?

"Currently, there are 3121 clinical trials researching the efficacy of Tiragolumab. Of those in operation, 740 are at a Phase 3 level. Mostly situated around Guangzhou, Guangdong Province; 134877 sites worldwide have initiated research on this medication."

Answered by AI

Has Tiragolumab received the necessary governmental sanctions for use in medical treatments?

"Tiragolumab's safety is asssessed to be a 1 on our scale, since this is an early-phase trial with limited evidence supporting its efficacy and security."

Answered by AI

What medical conditions commonly respond to treatment with Tiragolumab?

"Tiragolumab can be employed to tackle melanoma, neoplasm metastasis and the more serious malignant melanoma of skin."

Answered by AI

Are there still openings for participants in this trial?

"The data from clinicaltrials.gov indicates that this study is actively seeking participants as of 11/22/2022, having been initially listed on 5/23/2016."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02794571.

All > Paid Studies Connecticut