Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT04963283
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Cabozantinib — DRUG
    Cabozantinib is a multi-targeted inhibitor of RTKs. The targets of cabozantinib include several RTKs known to play important roles in tumor cell proliferation and/or tumor neovascularization, namely MET, VEGFR2 (also known as KDR), AXL, and RET. Other recognized targets of cabozantinib include ROS1, TRKA, TRKB, TIE2, TYRO3, and MER, two additional members of the VEGFR family (VEGFR1, VEGFR3), and the closely related RTKs KIT and FLT-3. The mode of action for cabozantinib is similar to other drugs targeting RTKs: binding in a fully reversible manner to a region of the kinase domain (including the ATP-binding site) which forces the kinase activation loop into a pseudo-inactive conformation, thereby inhibiting subsequent catalytic activity.
  • Nivolumab — DRUG
    Nivolumab is a human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. Nivolumab binds specifically to the human PD-1 receptor and inhibits the interaction of PD-1 with its ligands, programmed death ligands-1 (PD-L1) and 2 (PD-L2), which promotes immune responses and antigen-specific T-cell responses to foreign- and self- antigens. Nivolumab is expressed in Chinese hamster ovary (CHO) cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies.

Study Details

Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cabozantinib and nivolumab in patients with metastatic MSS CRC in the third line setting and beyond.

Key Dates

Start date
Jun 23, 2021
Status verified
Mar 2026
Primary completion
Feb 24, 2026
Completion
Feb 9, 2027

Study Design

Enrollment
48 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days.
    Cabozantinib is supplied as 20-mg tablets and will be administered orally at a dose of 40 mg/day. Nivolumab is supplied in 100 mg/Vial (10 mg/mL) vials and will be administered IV at a dose of 480 mg every 28 days.

Primary Outcome Measure

Disease Control Rate (DCR) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 24 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80012-
UCHealth Memorial Hospital CentralColorado SpringsColorado80909-
UCHealth Harmony CampusFort CollinsColorado80528-
UCHealth Family Medicine - GreeleyGreeleyColorado80634-
UCHealth Medical Center of the RockiesLovelandColorado80538-

Find similar trials in Aurora, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Colorado Hospital· Aurora, COUCHealth Memorial Hospital Central· Colorado Springs, COUCHealth Harmony Campus· Fort Collins, COUCHealth Family Medicine - Greeley· Greeley, COUCHealth Medical Center of the Rockies· Loveland, CO

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