Health Trials

About this trial

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)

Eligibility criteria

Qualifiers

Adult patients age ≥ 18 years.

Histologically confirmed diagnosis of ccRCC by a core-needle biopsy. Patients who have not had prior biopsy may undergo screening if they have suspected RCC but can only proceed to registration if ccRCC (any component) is confirmed on the pre-treatment study biopsy.

Stage cT2 RCC with grade 4 or sarcomatoid features, ≥cT3 Nx RCC, or cTany N+ RCC disease for which partial or radical nephrectomy is planned. For clinical staging, a kidney MRI is highly preferred over a CT Abdomen.

Participants must have measurable disease i.e. a primary renal tumor that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT scan or MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.

Disqualifiers

Any prior systemic therapy for treatment of renal cell carcinoma.

Any radiation therapy within 4 weeks before the first dose of study treatment.

Any clear evidence of distant metastases. Enlarged lymph nodes that are planned to be removed during nephrectomy are permitted.

Clinical pneumonitis or concern for inflammatory lung disease at time of screening.

Trial design

Treatments tested in this trial

  • Casdatifan
  • Zimberelimab

Treatment groups

32 Participants
are divided into 2 treatment groups

Locations

3
Beth Israel Deaconess Medical Center02215, BostonMassachusetts, United States
Brigham and Women's Hospital02215, BostonMassachusetts, United States
Dana-Farber Cancer Institute02215, BostonMassachusetts, United States

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

Arcus Biosciences, Inc.

Collaborator

Source ClinicalTrials.gov