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Checkpoint Inhibitor

Inavolisib + Atezolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Documented positive or negative HPV status

Participants not suitable for surgery and/or radiation

Must not have

Prior treatment with PI3K, AKT, or mTOR inhibitor

Type II diabetes requiring ongoing systemic treatment or history of Type I diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

"This trial aims to test the safety and effectiveness of inavolisib alone and in combination with atezolizumab in patients with specific types of cancer, including head and neck cancer that has

Who is the study for?

This trial is for people with PIK3CA-mutated cancers, specifically those who have previously treated head and neck squamous cell carcinoma (HNSCC). Participants must not be suitable for surgery/radiation, have a life expectancy of at least 12 weeks, an ECOG Performance Status of 0 or 1, and provide tissue samples. Exclusions include prior treatment with certain inhibitors, diabetes requiring systemic treatment, recent malignancies other than HNSCC within the last five years, cardiovascular issues, allergies to inavolisib components among others.

What is being tested?

The study tests the safety and effectiveness of Inavolisib alone and combined with Atezolizumab in treating cancer. It targets patients whose tumors show a specific genetic change (PIK3CA mutation) and measures how well these treatments work against their cancer.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs due to Atezolizumab. Inavolisib could cause blood sugar levels changes given its action on cellular pathways involved in metabolism. Both drugs can also lead to common drug-related side effects like fatigue or digestive discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I know if my cancer is HPV positive or negative.

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I cannot undergo surgery or radiation for my condition.

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My head or neck cancer has returned or spread and was treated before.

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My tumor has a PIK3CA mutation.

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I agree to provide a sample of my tumor for testing.

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I am fully active or can carry out light work.

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I do not have active hepatitis B.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with a PI3K, AKT, or mTOR inhibitor.

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I have diabetes and am on medication.

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I have not had any other cancer in the last 5 years.

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I am on long-term corticosteroid therapy.

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I have a history of heart problems.

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I have eye conditions that need treatment.

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I have symptoms from my lung condition.

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I have a condition that affects how my body absorbs nutrients.

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I haven't needed IV antibiotics for a serious infection in the last 7 days.

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I have not received a live vaccine in the last 4 weeks.

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I need extra oxygen every day.

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I have a history of or currently have inflammatory bowel disease.

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I am not taking medication that strongly affects liver enzyme levels.

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I have had a major surgery or serious injury recently.

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I have untreated brain metastases.

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I frequently need fluid drained from around my lungs, heart, or abdomen.

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I have an active eye infection or inflammation.

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I am HIV positive.

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I do not have any uncontrolled illnesses.

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I have recently undergone treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment2 Interventions

Participants in this group will receive inavolisib tablets, to be taken PO, QD and atezolizumab given as an intravenous (IV) infusion once every 3 weeks (Q3W).

Group II: Arm AExperimental Treatment1 Intervention

Participants in this group will receive inavolisib tablets, to be taken by mouth (PO), once daily (QD), on Days 1-21 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Inavolisib

2021

Completed Phase 2

~260

Atezolizumab

2017

Completed Phase 3

~5850

0 / 27Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,444 Previous Clinical Trials

1,093,082 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,212 Previous Clinical Trials

892,376 Total Patients Enrolled

~18 spots leftby Jun 2025

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