ACTIVE_NOT_RECRUITING

A Study to Investigate the Efficacy and Safety of Volrustomig ± Casdatifan vs Nivolumab + Ipilimumab as 1L Treatment for Advanced ccRCC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).

Official Title

A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Quick Facts

Study Start:2025-07-28
Study Completion:2032-07-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07000149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed RCC with clear cell component.
  2. * Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
  3. * Karnofsky Performance Status ≥ 70%.
  4. * Provision of acceptable tumor sample.
  5. * At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
  1. * History of leptomeningeal disease or spinal cord compression.
  2. * Symptomatic brain metastases.
  3. * Medical history of severe chronic obstructive pulmonary disease.
  4. * Active or prior documented autoimmune or inflammatory disorders.
  5. * Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.

Contacts and Locations

Study Locations (Sites)

Research Site
La Jolla, California, 92037
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
New York, New York, 10065
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Nashville, Tennessee, 37232
United States
Research Site
Lubbock, Texas, 79430
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-28
Study Completion Date2032-07-29

Study Record Updates

Study Start Date2025-07-28
Study Completion Date2032-07-29

Terms related to this study

Keywords Provided by Researchers

  • Programmed cell death-ligand-1
  • Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4)
  • First-line treatment (1L)
  • Immunotherapy
  • Kidney cancer
  • Clear cell renal carcinoma
  • Immuno-oncology bispecific (IO-bispecific)
  • Volrustomig
  • Casdatifan
  • Hypoxia-inducible factor-2α (HIF-2α)

Additional Relevant MeSH Terms

  • Advanced Clear Cell Renal Cell Carcinoma