XL092 + Nivolumab for Kidney Cancer
(EXACT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, there is a required 2-week washout period for those who have progressed on adjuvant anti-PD-1 therapy before starting the study treatment.
What data supports the effectiveness of the drug combination XL092 and Nivolumab for kidney cancer?
Is the combination of XL092 and Nivolumab safe for humans?
Nivolumab, used for kidney cancer, generally has a manageable safety profile, though it can cause side effects like tubulointerstitial nephritis (a kidney condition). In patients with severe kidney issues, nivolumab did not show increased toxicity, suggesting it is similarly safe for those with or without kidney problems.16789
What makes the drug XL092 + Nivolumab unique for kidney cancer?
The combination of XL092 and Nivolumab is unique because it pairs a new investigational drug, XL092, with Nivolumab, an established immune checkpoint inhibitor that helps the immune system attack cancer cells. This combination aims to enhance the effectiveness of treatment by targeting different pathways involved in kidney cancer growth and immune evasion.1291011
What is the purpose of this trial?
The study population for this Phase 2 study will include men and women ≥ 18 with confirmed renal cell carcinoma who have progressed on adjuvant anti-PD-1/PD-L1 therapy, the current standard of care. Subjects will be randomized to Arm A or Arm B. Study treatment will be given in 28-day (4 week) cycles. Arm A treatment will consist of XL092 alone and will be taken once daily continuously (Day 1-Day 28). Arm B treatment will consist of XL092 plus nivolumab. XL092 will be taken once daily continuously (Day 1-Day 28) and nivolumab will be administered every 4 weeks (Day 1). Treatment will continue until progression by RECIST 1.1, toxicity, or other reasons as appropriate.
Research Team
Karie Runcie, MD
Principal Investigator
Columbia University
Eligibility Criteria
Adults over 18 with renal cell carcinoma (a type of kidney cancer) who've seen their cancer progress after standard anti-PD-1/PD-L1 therapy can join. They must have measurable disease, good performance status (able to carry out daily activities), and adequate organ function. Those with unresolved severe side effects from previous treatments or insufficient blood counts are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive XL092 alone or in combination with nivolumab in 28-day cycles until progression, toxicity, or other reasons
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- XL092
Find a Clinic Near You
Who Is Running the Clinical Trial?
Karie Runcie
Lead Sponsor
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Columbia University
Collaborator