What side effects are associated with this type of intervention?

Common treatments for kidney cancer, such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and tyrosine kinase inhibitors (e.g., axitinib, sunitinib), often have side effects that include fatigue, diarrhea, hypertension, liver enzyme abnormalities, and skin reactions. Immune checkpoint inhibitors can also cause immune-related adverse events like colitis, pneumonitis, and thyroid dysfunction. Tyrosine kinase inhibitors may lead to hand-foot syndrome, gastrointestinal symptoms, and cardiovascular issues. These side effects are important to monitor and manage in patients undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for kidney cancer that enhance anti-tumor immune responses. Notable approvals include immune checkpoint inhibitors such as pembrolizumab and nivolumab, often used in combination with VEGFR inhibitors like axitinib. Pembrolizumab combined with axitinib and nivolumab combined with ipilimumab are examples of such combinations. These treatments aim to boost the body's immune response against cancer cells, similar to the investigational agent Tobemstomig (RO7247669) being studied in combination with axitinib and tiragolumab.

What other types of research exist?

Promising alternatives to Tobemstomig (RO7247669) for kidney cancer patients include: 1) Pembrolizumab in combination with axitinib, which has shown efficacy in advanced renal cell carcinoma. 2) Nivolumab plus ipilimumab, which has demonstrated significant clinical activity in advanced renal cell carcinoma. 3) Avelumab plus axitinib, which has been evaluated in the JAVELIN Renal 101 trial and shown positive results. These alternatives target immune checkpoints and have been validated in clinical trials, making them viable options for treatment in 2024.

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Tyrosine Kinase Inhibitor

Immune Checkpoint Inhibitors + Axitinib for Kidney Cancer

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

International Metastatic RCC Database Consortium (IMDC) risk intermediate (score of 1 or 2) or poor (score of 3-6)

Measurable disease with at least one measurable lesion

Must not have

Inability to swallow a tablet or malabsorption syndrome

History of congenital QT syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug combination for patients with advanced kidney cancer that can't be removed by surgery. The treatment aims to stop the cancer by blocking its blood supply and boosting the immune system. The combination of atezolizumab and bevacizumab has shown promise in treating advanced kidney cancer by helping patients live longer without the disease worsening.

Who is the study for?

This trial is for adults with advanced kidney cancer that hasn't been treated yet. They should be able to perform daily activities with ease (ECOG PS of 0 or 1) and have a certain level of risk based on the IMDC score. Participants must not have HIV, hepatitis B/C, serious infections recently, autoimmune diseases, significant bleeding events or other cancers in the last two years. Pregnant women and those who can't take oral medication are excluded.

What is being tested?

The study tests combinations of immune checkpoint inhibitors (Tiragolumab, Tobemstomig) with Axitinib against Pembrolizumab plus Axitinib in patients with untreated renal cell carcinoma. It aims to compare their effectiveness and safety while also studying how these drugs behave in the body over time.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions from drug administration into a vein, increased risk of infections due to weakened immunity, liver problems, fatigue and possibly digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer is classified as intermediate or poor risk.

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I have at least one tumor that can be measured.

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

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My kidney cancer is confirmed by a lab test.

Exclusion Criteria

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

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I cannot swallow pills or have a condition that affects how my body absorbs nutrients.

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I have a history of congenital QT syndrome.

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I need IV fluids, nutrition, or tube feeding due to GI issues.

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I have not had severe bleeding in the last 28 days.

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I have had cancer spread to the lining of my brain and spinal cord.

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I do not have any current stomach or digestive system issues.

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I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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I frequently need procedures to remove excess fluid from my body.

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I am using or might need strong medication that affects liver enzymes.

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My high blood pressure is not under control.

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My cancer has spread to the blood vessels in my lungs or caused lung cavities.

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I am allergic to certain medications or their ingredients.

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My cancer has spread to my digestive system.

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I have received treatments for kidney cancer, including immune therapies.

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I have brain metastases that are untreated or getting worse.

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I have not had a stroke, heart attack, or blood clot in the last 3 months.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I have active tuberculosis.

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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.

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My liver function is significantly impaired.

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I have had a previous transplant of stem cells or an organ.

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My cancer causes me pain that my current medication doesn't control.

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I have a history of serious irregular heartbeats.

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I have high calcium levels in my blood that are not under control or cause symptoms.

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

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (Tobemstomig + Tiragolumab + Axitinib)Experimental Treatment3 Interventions

Participants will receive IV tobemstomig followed by IV tiragolumab Q3W on Day 1 of 21-day cycle. Participants will also receive axitinib PO BID.

Group II: Arm A (Tobemstomig + Axitinib)Experimental Treatment2 Interventions

Participants will receive intravenous (IV) tobemstomig every three weeks (Q3W) on Day 1 of each 21-day cycle. Participants will also receive oral (PO) axitinib twice daily (BID).

Group III: Control Arm (Pembrolizumab + Axitinib)Active Control2 Interventions

Participants will receive IV pembrolizumab Q3W on Day 1 of each 21-day cycle. Participants will also receive axitinib PO BID.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

2020

Completed Phase 2

~3050

Tiragolumab

2019

Completed Phase 3

~2330

0 / 29Eligibility criteria met

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

The most common treatments for kidney cancer include immune checkpoint inhibitors and tyrosine kinase inhibitors. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. Tyrosine kinase inhibitors, like axitinib and sunitinib, inhibit enzymes involved in the growth and spread of cancer cells by blocking signaling pathways essential for tumor angiogenesis and proliferation. These treatments are crucial for kidney cancer patients as they target the cancer cells more precisely, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.