Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma
Conditions
Keywords
Casdatifan, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Kidney Cancer, PEAK-1, AB521, ccRCC
Brief summary
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.
Interventions
DRUGCasdatifan
Administered as specified in the treatment arm
DRUGCabozantinib
Administered as specified in the treatment arm
DRUGPlacebo
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, ≤ 1 week 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. * Ongoing 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, defined as a sustained blood pressure \> 150 mmHg systolic or \> 90 mmHg diastolic despite optimal antihypertensive treatment. * History of leptomeningeal disease or spinal cord compression. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 | up to approximately 33 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | up to approximately 64 months |
| Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 | up to approximately 33 months |
| Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 | up to approximately 33 months |
| Disease Control Rate (DCR) by Blinded Independent Central Review (BICR) | up to approximately 33 months |
| The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs) | up to approximately 33 months |
| Time to first symptom deterioration in National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (NFKSI-DRS) Items 1-9 sub-scale score. | up to approximately 33 months |
Countries
Argentina, Australia, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Romania, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTMedical Director
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed