Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Conditions

• Non-Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• XL092 — DRUG
  Specified doses on specified days
• Nivolumab — DRUG
  Specified doses on specified days
• Sunitinib Malate — DRUG
  Specified doses on specified days

Study Details

This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.

Key Dates

Start date

Jan 1, 2023

Status verified

Jul 2025

Primary completion

Jul 31, 2025

Completion

Jun 30, 2028

Study Design

Enrollment

317 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: XL092 + Nivolumab
  Subjects with advanced or metastatic nccRCC will receive XL092 + nivolumab
• Active Comparator: Sunitinib Malate
  Subjects with advanced or metastatic nccRCC will receive an active comparator of sunitinib

Primary Outcome Measure

Duration of Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) [ Time Frame: Approximately 27 months after the first subject is randomized ]

Locations (10)

Related coverage on Hipa.ai

• Nivolumab + XL092 Trial in Non-Clear Cell RCC Reaches Primary Completion
  Nivolumab · Jul 31, 2025 · ClinicalTrials.gov

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