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 Jibran Ahmed

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

No Placebo-Only Group

Summary

This trial tests if the combination of atezolizumab and tiragolumab can help treat patients with advanced rare solid tumors. Atezolizumab is a type of drug that helps the immune system fight cancer. These drugs aim to boost the immune system to fight cancer more effectively. The study will also collect samples to understand how the treatment works and who might benefit most from it.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Pharmacodynamic (PD) response rate

Secondary study objectives

Objective tumor response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 at baseline, undergo biopsy at baseline and on study, and undergo CT and collection of blood samples throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

2019

Completed Phase 3

~2330

Atezolizumab

2016

Completed Phase 3

~5860

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Echocardiography

2013

Completed Phase 4

~11580

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.