Clinical Research Directory

A Phase III Randomized Controlled Trial of Serplulimab Plus Fruquintinib as Adjuvant Therapy for High-Risk Non-Clear Cell Renal Cell Carcinoma

People with non-clear cell renal cell carcinoma may remain at high risk of cancer recurrence even after surgery has removed all visible disease. This study will test whether treatment after surgery with serplulimab plus fruquintinib improves outcomes compared with observation alone. This is a multicenter, randomized, open-label Phase III study. Approximately 108 adults will be assigned in a 1:1 ratio to receive the drug combination or observation. Participants in both groups will undergo scheduled follow-up. The main measure is the proportion of participants who remain free of recurrence two years after randomization. The study will also assess recurrence-free survival over time, overall survival, safety, and exploratory biomarkers.

Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study

The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.

Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.