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Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC

NCT07397611 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of this study is to see whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC).

The names of the study drugs involved in this study are:

* Casdatifan (a type of HIF-2α inhibitor)
* Zimberelimab (a type of monoclonal antibody)

Conditions

Interventions

DRUG

Casdatifan

HIF-2α inhibitor, tablet taken orally per protocol.

DRUG

Zimberelimab

monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.

Sponsors & Collaborators

Principal Investigators

  • Wenxin Xu, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2028-01-31
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07397611 on ClinicalTrials.gov