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

ConditionsMetastatic Clear Cell Renal Cell CarcinomaAdvanced Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorArcus Biosciences, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Casdatifan

    Drug

    Administered as specified in the treatment arm

  • Cabozantinib

    Drug

    Administered as specified in the treatment arm

  • Placebo

    Drug

    Administered as specified in the treatment arm

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Arm A (Experimental Arm)Experimental treatment 2 interventions
Group B: Arm B (Comparator Arm)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1

Time frame
up to approximately 33 months

Secondary outcomes

1

Overall Survival (OS)

Time frame
up to approximately 64 months
2

Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1

Time frame
up to approximately 33 months
3

Duration of Response (DOR) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1

Time frame
up to approximately 33 months
4

Disease Control Rate (DCR) by Blinded Independent Central Review (BICR)

Time frame
up to approximately 33 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arcus Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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