What side effects are associated with this type of intervention?

Common side effects of monoclonal antibodies used in the treatment of solid tumors, such as atezolizumab and tiragolumab, include fatigue, musculoskeletal pain, decreased appetite, pruritus (itching), diarrhea, nausea, rash, pyrexia (fever), cough, dyspnea (difficulty breathing), constipation, and abdominal pain. These treatments can also lead to immune-related adverse events (irAEs) such as dermatologic, gastrointestinal, hepatic, and endocrine issues due to the general enhancement of the immune system.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of solid tumors, which work by enhancing the immune system's ability to target and destroy cancer cells. Notable examples include pembrolizumab and nivolumab, both of which are anti-PD-1 antibodies that block the programmed death-1 (PD-1) pathway, thereby boosting the immune response against tumors. Atezolizumab, an anti-PD-L1 antibody, has also been approved for various cancers, including non-small cell lung cancer and urothelial carcinoma. These treatments are similar to the combination of atezolizumab and tiragolumab being studied, as they all aim to inhibit tumor growth and spread by modulating the immune system.

What other types of research exist?

Promising novel alternatives for solid tumor patients include Pembrolizumab, Nivolumab, and their combination therapies. Pembrolizumab has shown efficacy in various cancers, including gastric cancer, when used alone or with chemotherapy. Nivolumab, often combined with Ipilimumab, has demonstrated effectiveness in melanoma and esophageal squamous-cell carcinoma. These therapies target PD-1/PD-L1 pathways, similar to Atezolizumab and Tiragolumab, and have been associated with durable responses in clinical trials.

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Checkpoint Inhibitor

Atezolizumab + Tiragolumab for Rare Cancers

Phase 2

Recruiting

Led By Naoko Takebe

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests whether a combination of two immunotherapies can help shrink tumors in patients with advanced-stage rare solid tumors. Biopsies & blood samples are taken to measure response to the drugs.

Who is the study for?

Adults with advanced rare solid tumors that have progressed after standard therapy or lack a standard treatment. They must be willing to undergo biopsies, not qualify for higher priority trials, and have measurable disease. Key health criteria include stable organ function and controlled HIV or hepatitis if present. Pregnant women are excluded, and participants must agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the effectiveness of combining two immunotherapy drugs, Atezolizumab and Tiragolumab, in shrinking advanced stage rare solid tumors. It includes taking tissue samples before and after treatment to study the immune response against cancer.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions similar to allergic responses during drug administration, fatigue, blood disorders like low counts of different types of blood cells which can increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Change in the proportion of active CD8+ T cells infiltrating the tumor

Incidence of adverse events

Pharmacodynamic (PD) response rate

Secondary outcome measures

Objective tumor response rate (ORR)

Progression-free survival (PFS) time

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab, tiragolumab)Experimental Treatment6 Interventions

Patients receive atezolizumab IV over 60 minutes and tiragolumab IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening, and CT scans during screening, at the end of cycle 3 and every 2 cycles thereafter. Patients undergo tumor biopsy at baseline, on cycle 3 day 1 and optionally at response or disease progression, and blood sample collection at baseline, on day 1 of every subsequent cycle, and at time of response/disease progression on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

2020

Completed Phase 2

~460

Atezolizumab

2017

Completed Phase 3

~5860

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1720

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies like atezolizumab and tiragolumab enhance the immune system's ability to attack cancer cells by blocking inhibitory signals that tumors use to evade immune detection. Atezolizumab targets PD-L1, preventing it from binding to PD-1 on T cells, while tiragolumab targets TIGIT, another checkpoint protein. This dual blockade boosts T cell activity against tumors, potentially leading to more effective and durable responses. For solid tumor patients, these mechanisms offer hope for improved survival and tumor control by leveraging the body's own immune system to fight cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,717 Previous Clinical Trials

40,953,299 Total Patients Enrolled

Naoko TakebePrincipal InvestigatorNational Cancer Institute LAO

2 Previous Clinical Trials

95 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05715281 — Phase 2

Solid Tumors Research Study Groups: Treatment (atezolizumab, tiragolumab)

Solid Tumors Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05715281 — Phase 2

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05715281 — Phase 2

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