Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Purpose

The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.

Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma
  • Advanced Clear Cell Renal Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component. - A Karnofsky Performance Status (KPS) score ≥ 80% - At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy. - Adequate organ and marrow function, ≤ 72 hours prior to randomization. - Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.

Exclusion Criteria

  • Received prior treatment with a HIF-2α inhibitor or cabozantinib. - Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured. - Clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies. - Uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure > 140/90 mm Hg on more than three antihypertensives - History of leptomeningeal disease or spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (Experimental Arm) 		Casdatifan and cabozantinib taken orally
  • Drug: Casdatifan
    Administered as specified in the treatment arm
    Other names:
    • AB521
  • Drug: Cabozantinib
    Administered as specified in the treatment arm
Placebo Comparator
Arm B (Comparator Arm) 		Placebo and cabozantinib taken orally
  • Drug: Cabozantinib
    Administered as specified in the treatment arm
  • Drug: Placebo
    Administered as specified in the treatment arm

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Arcus Biosciences, Inc.

Study Contact

Medical Director
+1-510-462-3330
clinicaltrials@arcusbio.com