Pre-NEOSHIFT-RCC: Casdatifan and Zimberelimab for Kidney Cancer
This study is looking at whether casdatifan, a HIF-2α inhibitor, is safe and effective by itself or when combined with zimberelimab, a monoclonal antibody, for people with clear cell renal cell carcinoma (ccRCC), a type of kidney cancer, that can be removed by surgery. You can join if you are an adult (18 years or older) with a confirmed diagnosis of ccRCC. The main goal is to see how much the tumor shrinks before surgery. This study is currently recruiting about 32 participants, but the exact status is unclear.
- Study design
- This is an open-label, randomized study with two groups, comparing casdatifan alone to casdatifan plus zimberelimab. About 32 people are expected to participate.
- What's involved
- You will have screening for eligibility, in-clinic visits, blood tests, urine tests, CT scans, MRI scans, PET scans, and X-rays. Tumor size will be assessed around week 11 before surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Tumor size reduction is measured at a pre-surgery visit around week 11. Further follow-up is not specified.
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NCT07397611
Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC
Recruiting
PHASE2Ages 18+InterventionalTreatmentDana-Farber Cancer InstituteInvestigator-initiated
~32 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:CasdatifanZimberelimab
At a glance
Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor Size Reduction Rate
Measured over Disease assessment will occur at pre-surgery visit week 11 ± 2 weeks.
Conditions
Where it's being run
3 sites across 1 statesMassachusetts3
Study leadership
- Wenxin Xu, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Participants must be planned for surgical resection of their primary renal tumor.
ECOG performance status of 0-1.
Participants must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)
Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85
No exercise-induced desaturation on a 6-minute walk test, defined as a blood oxygen saturation by pulse oximetry ≤ 88%.
No active clinical pneumonitis at screening.
No medical history of severe chronic obstructive pulmonary disease (COPD)
Screening echocardiogram or MUGA scan must demonstrate a left ventricular ejection fraction (LVEF) greater than the institutional lower limit of normal (LLN).
Negative serum pregnancy test at screening for women of childbearing potential. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \< 55 years-of-age must have a serum follicle stimulating hormone \[FSH\] level \> 40 mIU/mL to confirm menopause). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.
Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Through 7 days after the last dose of casdatifan and 120 days after the last dose of zimberelimab for women of childbearing potential and for men
Ability to understand and the willingness to sign a written informed consent document.
Ability to swallow tablets.
Exclusion
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.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) with the intention to treat the disease under study within 2 weeks before first dose of study treatment.
Other prior malignancy active within the previous year except for locally curable cancers (\>90%) that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or Gleason 6 prostate cancer. Also, indolent malignancies, including but not limited to early-stage chronic lymphocytic leukemia and follicular lymphoma, that don't require anti-cancer treatment, could be allowed after discussion with the medical monitor.
QTc ≥ 480 msec using Fridericia's correction (QTcF) (based on an average of triplicate recordings).
Malabsorption condition that would alter the absorption of orally administered medications.
Patient has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event, pulmonary embolism, clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure.
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Other clinically significant disorders that would preclude safe study participation.
Major surgery (as defined in Appendix B) within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 7 days before the first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to the first dose of study treatment.
Patients who are receiving treatment with strong CYP3A4 inhibitors and inducers should have a washout period of 28 days or 5 half-lives of the concerning medicine prior to starting casdatifan.
History of psychiatric illness, mental condition or substance use disorders that are likely to interfere with ability to comply with protocol requirements or give informed consent.
Use of any live vaccines against infectious diseases within 28 days of first dose of study drug.
Current breastfeeding.
Previously identified allergy or hypersensitivity to components of the study treatment formulations.
Any use of supplemental or intermittent oxygen therapy.
Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.
What this trial measures
- Tumor Size Reduction RateDisease assessment will occur at pre-surgery visit week 11 ± 2 weeks.
Tumor size reduction rate is defined as the proportion of participants who achieve any decrease in the maximal dimension of the primary tumor.