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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07397611
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Casdatifan — DRUG
    HIF-2α inhibitor, tablet taken orally per protocol.
  • Zimberelimab — DRUG
    monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.

Study Details

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)

Key Dates

Start date
Mar 9, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Casdatifan
    16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): --Days 1 - 21: Predetermined dose of Casdatifan 1x daily * standard of care nephrectomy * Follow up for up to 3 years
  • Experimental: Group B: Casdatifan + Zimberelimab
    * 16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): * Days 1 - 21: Predetermined dose of Casdatifan 1x daily * Day 1: Predetermined dose of Zimberelimab * Standard of care nephrectomy * Follow up for up to 3 years

Primary Outcome Measure

Tumor Size Reduction Rate [ Time Frame: Disease assessment will occur at pre-surgery visit week 11 ± 2 weeks. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
David Einstein, MD
[email protected]
617-667-1957
David Einstein, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02215
Wenxin Xu, MD
[email protected]
617-632-6534
Wenxin Xu, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Wenxin Xu, MD
[email protected]
617-632-6534
Wenxin Xu, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Kidney cancer
By specialty
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By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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