RECRUITING

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

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).

Conditions

Advanced Clear Cell Renal Cell Carcinoma
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Related Conditions:

Advanced Clear Cell Renal Cell Carcinoma

Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Advanced Clear Cell Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

La Jolla

Research Site, La Jolla, California, United States, 92037

Aurora

Research Site, Aurora, Colorado, United States, 80045

Boston

Research Site, Boston, Massachusetts, United States, 02215

New York

Research Site, New York, New York, United States, 10065

Cleveland

Research Site, Cleveland, Ohio, United States, 44106

Nashville

Research Site, Nashville, Tennessee, United States, 37232

Lubbock

Research Site, Lubbock, Texas, United States, 79430

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically or cytologically confirmed RCC with clear cell component.
  • * Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
  • * Karnofsky Performance Status ≥ 70%.
  • * Provision of acceptable tumor sample.
  • * 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.
  • * History of leptomeningeal disease or spinal cord compression.
  • * Symptomatic brain metastases.
  • * Medical history of severe chronic obstructive pulmonary disease.
  • * Active or prior documented autoimmune or inflammatory disorders.
  • * Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2032-07-29