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Tyrosine Kinase Inhibitor
Immune Checkpoint Inhibitors + Axitinib for Kidney Cancer
Phase 2
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 treatment cycles (cycle length = 21 days)
Awards & highlights
Study Summary
This trial will study a new drug combo to treat unresectable kidney cancer, to see if it's safer and more effective than existing treatments.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 35 treatment cycles (cycle length = 21 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 treatment cycles (cycle length = 21 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Confirmed Objective Response Rate (ORR)
Duration of Response (DoR)
Overall Survival (OS)
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
Tiragolumab
2020
Completed Phase 2
~460
Axitinib
2020
Completed Phase 2
~3050
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.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,182 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,202 Previous Clinical Trials
889,826 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot swallow pills or have a condition that affects how my body absorbs nutrients.I have a history of congenital QT syndrome.I need IV fluids, nutrition, or tube feeding due to GI issues.I have not had severe bleeding in the last 28 days.You have a condition that causes abnormal bleeding or blood clotting.I haven't had major blood vessel problems or surgery for them in the last 6 months.I have had cancer spread to the lining of my brain and spinal cord.I have not had a severe infection in the last 4 weeks.I have not had a major heart or stroke event in the last 3 months.I do not have any current stomach or digestive system issues.I haven't had cancer other than kidney cancer in the last 2 years, except for very low-risk types.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.I have had a severe hypertension crisis or brain issues due to high blood pressure.Your heart beats too fast when you are resting.I frequently need procedures to remove excess fluid from my body.I am using or might need strong medication that affects liver enzymes.You have or had a condition where your immune system attacks your own body or you have a weak immune system.You have air in your abdomen that isn't from a recent surgery or a specific medical procedure.My high blood pressure is not under control.My cancer has spread to the blood vessels in my lungs or caused lung cavities.I haven't had significant bleeding or blood disorders in the last 3 months.I am allergic to certain medications or their ingredients.My kidney cancer is classified as intermediate or poor risk.My cancer has spread to my digestive system.I have at least one tumor that can be measured.I have received treatments for kidney cancer, including immune therapies.I have brain metastases that are untreated or getting worse.I am not pregnant or breastfeeding and do not plan to become pregnant during the study or within the specified time after the last dose.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I have not had a stroke, heart attack, or blood clot in the last 3 months.I have active tuberculosis.I have not had an abdominal abscess in the last 6 months.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have not taken any strong antibiotics in the last 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.My liver function is significantly impaired.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.You do not have HIV, hepatitis B, or hepatitis C.I have had a previous transplant of stem cells or an organ.My cancer causes me pain that my current medication doesn't control.I have a history of serious irregular heartbeats.You have an ongoing Epstein-Barr virus (EBV) infection or suspected long-term EBV infection.I have high calcium levels in my blood that are not under control or cause symptoms.My kidney cancer is confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Tobemstomig + Axitinib)
- Group 2: Arm B (Tobemstomig + Tiragolumab + Axitinib)
- Group 3: Control Arm (Pembrolizumab + Axitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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