Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05969496
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axitinib — DRUG
    Axitinib is a potent oral, vascular endothelial growth factor, c-kit and platelet derived growth factor inhibitor.
  • Pembrolizumab — DRUG
    Pembrolizumab is a type of immunotherapy. It stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.

Study Details

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.

Key Dates

Start date
Dec 4, 2023
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Nov 30, 2029

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Pembrolizumab and Axitinib
    Neoadjuvant therapy with the combination of Pembrolizumab and Axitinib will be given for eligible RCC patients with an IVC TT for a total of 12 weeks. Patients will then undergo imaging with a contrast enhanced, diffusion weighted imaging MRI of the abdomen to evaluate the IVC TT response. A CT chest will also be done to ensure there is no progression of disease. Patients can undergo definitive surgery per treating Urologist within 2 weeks (+/- 7 days) after end of treatment scan.

Primary Outcome Measure

Evaluate Change in IVC Tumor Thrombus Extent Based on the Mayo Classification [ Time Frame: baseline and 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045
Elizabeth Kessler
[email protected]
7208480170
Corbin Eule, MD (SUB_INVESTIGATOR)
Sandra Everett, FNP, MSN, RN (SUB_INVESTIGATOR)
Hilands Ranch HospitalHighlands RanchColorado80129
Matthew Lee
[email protected]
720-848-0630
Elizabeth Kessler, MD (PRINCIPAL_INVESTIGATOR)
Lone Tree Medical CenterLone TreeColorado80124
Matthew Lee
[email protected]
720-848-0630
Elizabeth Kessler, MD (PRINCIPAL_INVESTIGATOR)

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