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

Recruiting in Palo Alto (17 mi)

+235 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

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.

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.

+10 more

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.

+19 more

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as Tecentriq for: