What side effects are associated with this type of intervention?

Common treatments for Renal Cell Carcinoma, such as Cabozantinib and the Cabozantinib-Nivolumab combination, have distinct side effect profiles. Cabozantinib, a Tyrosine Kinase Inhibitor, often causes hypertension, diarrhea, fatigue, and hand-foot syndrome. When combined with Nivolumab, an Immune Checkpoint Inhibitor, the side effects can include serious adverse events like skin reactions, endocrine events, and increased risk of severe immune-related reactions. Patients receiving the combination therapy may experience a higher incidence of serious adverse events compared to monotherapy, necessitating careful monitoring and management of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Renal Cell Carcinoma (RCC) that are similar to cabozantinib and the cabozantinib-nivolumab combination. Cabozantinib itself is approved for RCC, both as a monotherapy and in combination with nivolumab. Other approved tyrosine kinase inhibitors (TKIs) for RCC include sunitinib, pazopanib, axitinib, and lenvatinib. Immune checkpoint inhibitors (ICIs) like nivolumab and pembrolizumab have also been approved, often in combination with TKIs or other ICIs such as ipilimumab. These combinations have shown efficacy in improving progression-free survival and overall survival in patients with advanced RCC.

What other types of research exist?

Promising alternatives to Cabozantinib and the Cabozantinib-Nivolumab combination for RCC patients include: 1) Nivolumab plus Ipilimumab, which has shown durable long-term responses and potential for treatment-free intervals. 2) Pembrolizumab plus Axitinib, which has demonstrated improved quality of life and efficacy in advanced RCC. 3) Atezolizumab plus Bevacizumab, which has shown positive results in untreated metastatic RCC. These combinations leverage immune checkpoint inhibitors and antiangiogenic agents to provide effective treatment options.

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Tyrosine Kinase Inhibitor

Cabozantinib + Nivolumab for Kidney Cancer

Phase 2

Recruiting

Led By Tian Zhang, MD

Research Sponsored by University of Texas Southwestern Medical Center

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 follow up until death or withdrawal, up to 36 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing higher doses of cabozantinib or a combination of cabozantinib with nivolumab in patients with advanced kidney cancer who did not respond to previous treatment. Cabozantinib stops cancer growth, while nivolumab helps the immune system fight the cancer. Cabozantinib and nivolumab have been used together to treat advanced renal cell carcinoma, showing benefits in disease control and survival.

Who is the study for?

Adults with advanced kidney cancer who've seen their disease progress after cabozantinib treatment can join. They must have used cabozantinib for over 6 months, be able to take it without severe side effects, and not be on certain medications or have specific health conditions. Participants need measurable cancer growth, good organ function, and a performance status indicating they can walk and care for themselves.

What is being tested?

The trial is testing two approaches in patients whose kidney cancer has worsened despite previous treatment: one group will receive a high dose of cabozantinib alone, while the other will get a lower dose combined with nivolumab. The choice between these options depends on what dosage participants tolerated before.

What are the potential side effects?

Cabozantinib may cause diarrhea, high blood pressure, fatigue, loss of appetite, weight loss and nausea. Nivolumab could lead to immune-related issues like inflammation in organs such as lungs or intestines; skin problems; hormonal gland changes; liver dysfunction; or infusion reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow up until death or withdrawal, up to 36 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow up until death or withdrawal, up to 36 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up until death or withdrawal, up to 36 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

Progression free survival of cabozantinib or cabozantinib-nivolumab combination

Secondary study objectives

Disease Control Rate of of cabozantinib or cabozantinib-nivolumab combination

Duration of response of of cabozantinib or cabozantinib-nivolumab combination

Objective Response Rate of cabozantinib or cabozantinib-nivolumab combination

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: cabozantinib + nivolumabExperimental Treatment2 Interventions

cabozantinib 40mg PO daily + nivolumab 480 mg IV every 4 weeks (q4w)

Group II: Cohort 1: Cabozantinib Dose EscalationExperimental Treatment1 Intervention

cabozantinib 80mg PO daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

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

Renal Cell Carcinoma (RCC) treatments often involve Tyrosine Kinase Inhibitors (TKIs) and Immune Checkpoint Inhibitors (ICIs). TKIs, such as Cabozantinib, work by blocking specific enzymes (tyrosine kinases) that promote tumor growth and angiogenesis, thereby inhibiting cancer cell proliferation and blood vessel formation. Immune Checkpoint Inhibitors, like Nivolumab, enhance the immune system's ability to recognize and attack cancer cells by blocking proteins (PD-1/PD-L1) that prevent immune cells from targeting tumors. The combination of Cabozantinib and Nivolumab leverages both mechanisms, offering a dual approach that not only directly inhibits tumor growth but also boosts the body's immune response against cancer cells. This combination is particularly significant for RCC patients as it can lead to improved overall survival and progression-free survival, providing a more effective treatment option.