Stellar 304

Actively Recruiting

Phase 3 Randomized, Open-Label Study of XL092 With Nivolumab vs Sunitinib in Advanced or Metastatic Non–Clear Cell Renal Cell Carcinoma

THE COMBINATION OF XL092 AND NIVOLUMAB IS NOT APPROVED FOR THE USE UNDER INVESTIGATION IN THIS TRIAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.

  • Study Overview

  • Key Eligibility Criteria

  • Key Endpoints

  • Participating Sites

  • Resources for HCPs

Study Overview

Rationale

Non–clear cell renal cell carcinoma (nccRCC) encompasses 25% of all RCC tumors. The most common histological subtype is papillary (15% of all RCC). Minor subtypes include translocation-associated RCC (≤1%) and unclassified (4%).1 For patients with nccRCC, there have been no dedicated, randomized phase 3 studies to adequately characterize benefit, thus a standard-of-care (SOC) therapy has not yet been established.

Design

Approximately 291 eligible patients from 170 sites globally (North America, South America, Europe, and Asia Pacific) will be enrolled in STELLAR-304. Patients with unresectable, advanced, or metastatic nccRCC will be randomly assigned in a 2:1 ratio to XL092 in combination with nivolumab or to sunitinib to evaluate the effect of the combination therapy on progression-free survival (PFS) and objective response rate (ORR) versus sunitinib.

Chart explaining phase 3 randomized, open-label study of XL092 with nivolumab vs sunitinib in advanced nccRCC

Stratification Factors

  • Presence of sarcomatoid features

  • IMDC prognostic score (favorable vs intermediate vs poor)

Key Eligibility Criteria

  • Unresectable, advanced, or metastatic nccRCC (papillary, unclassified, and translocation subtypes); sarcomatoid features allowed

  • Measurable disease

  • No prior systemic anticancer therapy for unresectable, locally advanced, or metastatic nccRCC

    • One prior systemic adjuvant therapy, excluding sunitinib, allowed for completely resected RCC and if recurrence ≥6 months after last dose

Key Endpoints

Multiple Primary Endpoints

  • PFS by BICR

  • ORR by BICR

Secondary Endpoint

  • OS

Additional Endpoints

  • DOR by BICR

  • PFS, ORR, and DOR by investigator

  • PROs accessed by FKSI-19 and EQ-5D-5L

Participating Sites

STELLAR-304 will be conducted in North America, South America, Europe, and Asia Pacific.

Currently open clinical sites:

Trial sites may stop enrolling patients at any time. Please check back if you do not see a trial site located near you.

Resources for Healthcare Professionals

Here you can find further information on STELLAR-304. To view information for a specific language, select it from the dropdown below.

STELLAR 304 trial infographic summary for healthcare professionals

Trial Infographic Summary

A quick snapshot of the trial

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STELLAR 304 trial healthcare professional brochure

Healthcare Professional Brochure

Find out more details about the trial

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STELLAR 304 trial brochure for patients

Patient-friendly Brochure

Use to discuss with patients who wish to enroll

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Reference

  1. Hsieh JJ, et al. Renal cell carcinoma. Nat Rev Dis Primers. 2017;3:17009.

BICR, blinded independent central review; DOR, duration of response; EQ-5D-5L, EuroQol five-dimension, five-level health questionnaire instrument; FKSI, Functional Assessment of Cancer Therapy-Kidney Symptom Index; IMDC, International Metastatic RCC Database Consortium; IV, intravenous; nccRCC, non—clear cell renal cell carcinoma; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; q4w, once every 4 weeks; qd, once daily; RCC, renal cell carcinoma; SOC, standard of care.

To learn more about this trial, go to clinicaltrials.gov and search for NCT05678673, or contact Exelixis Medical Information at medinfo@exelixis.com.

Links to Exelixis Website

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