Atezolizumab + Cabozantinib for Kidney Cancer

(CONTACT-03 Trial)

Recruiting at 238 trial locations

Overseen By Reference Study ID Number: WO41994 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Anticoagulants, Platelet inhibitors

Disqualifiers: CNS metastases, Hypertension, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years 5 months

522 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase III, multicenter, randomized, open-label study designed to evaluate the efficacy and safety of atezolizumab given in combination with cabozantinib versus cabozantinib alone in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who experienced radiographic tumor progression during or after Immune Checkpoint Inhibitor (ICI) treatment in the metastatic setting.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Inclusion Criteria

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

I have recovered from previous cancer treatment side effects, except for moderate hair loss.

I can provide both old and recent tumor samples for the study.

Exclusion Criteria

I haven't had serious heart problems in the last 3 months.

I have been treated with an mTOR inhibitor before.

I have brain metastases that are untreated or getting worse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab every 3 weeks and cabozantinib daily, or cabozantinib daily alone

Up to 2 years 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Atezolizumab
• Cabozantinib

Trial Overview 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.

Participant Groups

Group I: Atezo+Cabo Experimental Treatment 2 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: Cabozantinib Active Control 1 Intervention

Participants will receive cabozantinib every day.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Chugai

Collaborator

Trials

1

Recruited

520+

Chugai Pharmaceutical

Industry Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University