Moffitt Cancer Center: Clinical Trial 20614

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Clinical Trial 20614

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04338269

Phase: Phase III
Prinicipal Investigator: Jad Chahoud

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase III, Multicneter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Atezolizumab Given in Combination with Cabozantinib versus Cabozantinib Alone in Patients with Inoperable, Locally, Advanced, or Metastatic Renal Cell Carcinoma Who Experienced Radiographic Tumor Progression During or After Immune Checkpoint Inhibitor Treatment

Summary

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.

Objective

This study will evaluate the efficacy and safety of atezolizumab when given in combination with cabozantinib (Atezo; Cabo) compared with cabozantinib alone in patients with advanced clear cell or non;clear cell RCC (papillary or unclassified only) who experienced radiographic tumor progression during or after ICI treatment in the metastatic setting.

Treatments

Therapies

Medications

Atezolizumab (Tecentriq); Cabozantinib (XL 184)

Inclusion Criteria

Inclusion Criteria:

Histologically confirmed locally advanced or metastatic clear cell or non-clear cell (papillary and unclassified only) RCC. RCC with sarcomatoid features is allowed.

Radiographic disease progression during or following treatment with ICI for locally advanced or metastatic RCC either in first- or second-line treatment. ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, or nivolumab. Only patients for whom the immediate preceding line of therapy was an ICI are allowed.

Measurable disease per RECIST v1.1

Evaluable IMDC risk score

Archival tumor specimen, and pretreatment tumor tissue from fresh biopsy at screening, if clinically feasible

KPS score of >=70

Adequate hematologic and end-organ function

Negative HIV test at screening

Negative hepatitis B testing at screening

Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs

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

Exclusion Criteria

Exclusion Criteria:

Treatment with anti-cancer therapy within 28 days prior to initiation of study treatment

Patients received cabozantinib at any time prior to screening

Patients who received more than 1 regimen of ICIs

Patients who received more than 2 prior lines of therapy in the advanced or metastatic setting

Patients who received ICI in the adjuvant setting (adjuvant VEGFR-TKI except cabozantinib is allowed)

Patients who have received a mammalian target of rapamycin (mTOR) inhibitor in the advanced or metastatic setting

Symptomatic, untreated, or actively progressing CNS metastases

History of leptomeningeal disease

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures

Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab

History of malignancy other than renal carcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death

Radiotherapy for RCC within 14 days prior to Day 1 of Cycle 1

Active tuberculosis

Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study

Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after final dose of atezolizumab and 4 months after final dose of cabozantinib

Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia

Uncontrolled hypertension defined as sustained blood pressure >150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, MI, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1

History of congenital QT syndrome

History or presence of an abnormal ECG that is clinically significant in the investigator's opinion

Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g. clopidogrel)

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.