Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Casdatifan
DrugHIF-2α inhibitor, tablet taken orally per protocol.
Zimberelimab
Drugmonoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Group A: CasdatifanExperimental treatment 1 intervention
Group B: Group B: Casdatifan + ZimberelimabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Tumor Size Reduction Rate
Tumor size reduction rate is defined as the proportion of participants who achieve any decrease in the maximal dimension of the primary tumor.
Time frame
Disease assessment will occur at pre-surgery visit week 11 ± 2 weeks.Secondary outcomes
1
Global Adverse Events (AE) Rate
The global AE rate is defined as the proportion of participants experiencing at least one adverse event of Grade ≥2 (as Grade 1 AEs are not collected per protocol) during the protocol-specified AE reporting period. All AEs are included regardless of treatment attribution. All AEs will be defined and graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Time frame
Assessed from treatment start and continuing through the first long-term follow-up visit at 3 months post-surgery, for a total maximum duration of approximately 24 weeks.2
Treatment Related Adverse Events (TRAEs) Rate
The TRAEs rate is the proportion of participants experiencing Grade ≥2 AEs that are at least possibly related to the study treatment (i.e., possibly, probably, or definitely related) during the protocol-specified AE reporting period. All AEs will be defined and graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame
Assessed from treatment start and continuing through the first long-term follow-up visit at 3 months post-surgery, for a total maximum duration of approximately 24 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Arcus Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov