What side effects are associated with this type of intervention?

The most common treatments for Renal Cell Carcinoma, such as Atezolizumab and Cabozantinib, have distinct side effect profiles. Atezolizumab, an immune checkpoint inhibitor, can cause fatigue, rash, diarrhea, liver enzyme abnormalities, and thyroid dysfunction. Cabozantinib, a VEGFR inhibitor, is associated with hypertension, diarrhea, fatigue, hand-foot syndrome, and elevated liver enzymes. Both treatments can also lead to more severe but less common side effects like gastrointestinal perforation and hemorrhage.

What prior FDA approvals exist?

The FDA has approved several treatments for Renal Cell Carcinoma (RCC) that involve immune system activation and tumor growth inhibition. Notably, immune checkpoint inhibitors such as Nivolumab (an anti-PD-1 antibody) and Pembrolizumab (another anti-PD-1 antibody) have been approved for RCC. Additionally, tyrosine kinase inhibitors (TKIs) like Cabozantinib, Sunitinib, and Axitinib have been approved for their ability to inhibit tumor growth by targeting VEGF receptors. Combination therapies, such as Nivolumab plus Ipilimumab (an anti-CTLA-4 antibody) and Pembrolizumab plus Axitinib, have also received FDA approval, reflecting a strategy similar to the Atezolizumab and Cabozantinib combination being studied.

What other types of research exist?

Promising alternatives for RCC treatment include the combination of Nivolumab and Ipilimumab, which has shown efficacy as first-line therapy. Additionally, Pembrolizumab combined with Axitinib and Lenvatinib combined with Pembrolizumab are also recommended based on recent clinical trial data. These combinations offer both immune system activation and tumor growth inhibition.

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Checkpoint Inhibitor

Atezolizumab + Cabozantinib for Kidney Cancer (CONTACT-03 Trial)

Phase 3

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

Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary, chromophobe, and unclassified only) RCC. RCC with sarcomatoid features is allowed. Patients with the chromophobe subtype of non-clear cell RCC must have sarcomatoid differentiation.

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Must not have

Patients received cabozantinib at any time prior to screening

History of leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new combination cancer treatment to see if it is more effective and has fewer side effects than the current standard of care.

Who is the study for?

This trial is for adults with advanced renal cell carcinoma who've seen their cancer grow despite previous immune checkpoint inhibitor therapy. They must have a certain level of physical health, no recent other cancer treatments or surgeries, and agree to contraception if applicable. Those with uncontrolled blood pressure, significant heart disease, active infections or hepatitis are excluded.

What is being tested?

The study compares the effectiveness and safety of atezolizumab combined with cabozantinib versus cabozantinib alone in patients whose kidney cancer has progressed after treatment with drugs that boost the immune system. It's an open-label Phase III trial where participants are randomly assigned to one of the two treatment groups.

What are the potential side effects?

Potential side effects include fatigue, high blood pressure, diarrhea, liver enzyme elevation, mouth sores, hand-foot syndrome (redness and pain on palms or soles), decreased appetite and weight loss. Some may experience more serious issues like severe infections or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My kidney cancer is advanced or has spread, and it's a specific type (clear cell, papillary, chromophobe, or unclassified).

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I agree to not have sex or will use a condom, and I won't donate sperm.

Select...

I am mostly able to care for myself.

Exclusion Criteria

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

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I have taken cabozantinib before.

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

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I have active tuberculosis.

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I am currently taking blood thinners like warfarin or clopidogrel.

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I have been treated with an mTOR inhibitor before.

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I have brain metastases that are untreated or getting worse.

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I have had more than one immune therapy for advanced cancer.

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I have had more than two treatments for my advanced cancer.

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

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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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I have untreated, symptomatic underactive thyroid.

Select...

I have a history of congenital QT syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the first occurrence of disease progression according to recist v1.1 (up to 2 years 5 months). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Progression Free Survival (PFS) as Assessed by an Independent Review Facility (IRF) (IRF-PFS) According to RECIST v1.1

Secondary study objectives

Independent Review Facility (IRF)-Assessed Duration of Response (DOR) (IRF-DOR) According to RECIST v1.1

Independent Review Facility (IRF)-Assessed Overall Response Rate (ORR) (IRF-ORR) According to RECIST v1.1

Investigator-assessed Duration of Response (DOR) (INV-DOR) According to RECIST v1.1

+2 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezo+CaboExperimental Treatment2 Interventions

Participants will receive atezolizumab every 3 weeks on Day 1 of each 21-day cycle (1 cycle=21 days) plus oral tablets of cabozantinib every day.

Group II: CabozantinibActive Control1 Intervention

Participants will receive cabozantinib every day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Cabozantinib

2020

Completed Phase 2

~1760

0 / 16Eligibility 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 Renal Cell Carcinoma (RCC) include immune checkpoint inhibitors like Atezolizumab and tyrosine kinase inhibitors like Cabozantinib. Atezolizumab works by activating the immune system to recognize and attack cancer cells, which is essential for targeting tumors that have progressed after other treatments. Cabozantinib inhibits tumor growth by blocking specific enzymes involved in cancer cell proliferation and survival. This dual approach is significant for RCC patients as it combines immune system activation with direct tumor growth inhibition, potentially improving treatment outcomes.

Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program.Emerging growth factor receptor antagonists for the treatment of renal cell carcinoma.Cabozantinib as a novel therapy for renal cell carcinoma.