Completed

CANTATAA Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

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What is being tested

CB-839

+ Cabozantinib

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2018
See protocol details

Summary

Principal SponsorCalithera Biosciences, Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 24, 2018

Actual date on which the first participant was enrolled.

Tthe primary objective of this study is to compare blinded Independent Radiology Committee (IRC)-adjudicated progression free survival (PFS) of patients treated with CB-839 + cabozantinib (CB-Cabo) versus placebo + cabozantinib (Pbo-Cabo) for advanced or metastatic clear-cell RCC (ccRCC).

Official TitleA Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)
NCT03428217
Principal SponsorCalithera Biosciences, Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

444 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaCarcinoma, Renal CellFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
Adult patients
Karnofsky Performance Score (KPS) ≥ 70%
Measurable Disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Show More Criteria
7 exclusion criteria prevent from participating
Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [MET] inhibitor) or CB-839
Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment
Untreated or active brain metastases or central nervous system cancer, as defined per protocol
Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
CB-839 800 mg BID + cabozantinib (60 mg QD) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per RECIST v1.1 or unacceptable toxicity, whichever occurred first.

Group II

Placebo
Placebo twice daily (BID) + cabozantinib (60 mg once daily \[QD\]) administered orally on Days 1 through 28 of each 28-day cycle until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or unacceptable toxicity, whichever occurred first.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 133 locations

Suspended

University of Alabama at Birmingham

Birmingham, United StatesOpen University of Alabama at Birmingham in Google Maps
Suspended

Mayo Clinic Cancer Center

Phoenix, United States
Suspended

The University of Arizona Cancer Center

Tucson, United States
Suspended

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, United States
Completed133 Study Centers