Actively Recruiting
Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-11-06
20
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).
CONDITIONS
Official Title
Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at study entry
- Ability to understand and follow the study requirements and have signed informed consent
- ECOG performance status 0 or 1, or Karnofsky Performance Status of at least 80%
- Life expectancy of at least 12 weeks
- Histologically confirmed advanced or metastatic clear cell renal cell carcinoma with less than 50% sarcomatoid features
- Patients with localized RCC that developed metastatic disease after surgery, with or without prior adjuvant therapy
- Classified as favorable, intermediate, or poor risk by MSKCC or IMDC models
- Measurable disease with at least one tumor mass 10 mm or larger by CT scan
- Adequate organ, marrow, and coagulation function based on specific lab values within 14 days before treatment
- Availability of tumor tissue sample for central testing
- Recovery to baseline or grade 1 or less from previous treatment toxicities
- Agreement to use effective contraception during and for 4 months after the study if sexually active and fertile
- Female participants of childbearing potential must have a negative pregnancy test before treatment or meet criteria confirming non-childbearing status
You will not qualify if you...
- Prior use of cabozantinib, nivolumab, ipilimumab, or other systemic kidney cancer therapy for advanced disease
- Anti-cancer therapy within 4 weeks or five half-lives before study treatment
- Use of kinase inhibitors within 2 weeks before treatment
- Recent radiation therapy within specified timeframes or ongoing complications from radiation
- Known brain metastases unless treated and stable for at least 4 weeks
- Use of certain anticoagulants, except allowed low-dose aspirin or stable anticoagulation without bleeding risks
- Uncontrolled or recent serious cardiovascular or gastrointestinal conditions
- Significant bleeding events within 12 weeks before treatment
- Cavitating lung lesions or disease invading major blood vessels
- Other significant disorders or conditions impacting safety or study participation
- Major surgery within 2 weeks or minor surgery within 10 days without complete healing
- Prolonged corrected QT interval on ECG
- Recent use of immunosuppressive medication except low-dose corticosteroids
- Pregnancy or breastfeeding
- Inability to swallow tablets
- History of severe allergic reactions to study drugs
- Other active cancers requiring treatment within 3 years, except certain cured cancers
- History of leptomeningeal carcinomatosis
- Use of systemic immune-stimulatory agents recently
- Recent live attenuated vaccination
- Previous severe immune-related adverse events
- Active or recent autoimmune or inflammatory diseases, except stable mild conditions
- Primary immunodeficiency or prior organ/stem cell transplant
- Participation in another investigational study within 28 days
- Any condition interfering with study evaluation or safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
C
Che-Kai Tsao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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