Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
The primary objective of this study is to evaluate whether the combination of Pembrolizumab and Axitinib given in the neoadjuvant setting can change the Inferior Vena Cava Tumor Thrombus burden. A decrease in the size of the tumor thrombus can potentially lead to decrease in surgical complications, improve patient related health outcomes, and improve long term outcomes such as progression free survival and overall survival.
Eligibility criteria
Qualifiers
Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Participant self-identified gender ages >/= 18 years old is acceptable and appropriate if they meet other inclusion criteria.
Histologically proven clear cell component RCC.
Disqualifiers
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to enrollment.
Has had major surgery within 4 weeks or received radiation therapy within 1 week prior to enrollment to the study.
Has had prior treatment with any anti-programmed cell death (anti-PD-1) or programmed cell death ligand 1 (PD-L1), or an antibody targeting any other immune-regulatory receptors or mechanisms.
Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR).
Trial design
Treatments tested in this trial
- Axitinib
- Pembrolizumab
Treatment groups
17 Participants
are divided into 1 treatment groupLocations
3University of Colorado Cancer Center80045, AuroraColorado, United States
Hilands Ranch Hospital80129, Highlands RanchColorado, United States
Lone Tree Medical Center80124, Lone TreeColorado, United States
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
Source ClinicalTrials.gov