Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Irvine, California.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06053658
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Tivozanib — DRUG
    Given by PO
  • Nivolumab — DRUG
    Given by IV (vein)

Study Details

To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.

Key Dates

Start date
Jan 5, 2024
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2028

Study Design

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

Arms

  • Experimental: Combination Tivozanib and Nivolumab
    Nivolumab by vein over about 60 minutes every 4 weeks (Day 1 of each cycle). Tivozanib tablets by mouth 1 time every day for 21 days (Days 1-21 of each cycle), and then no tablets on Days 22-28 of each cycle.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; average of 1 year ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeIrvineCalifornia92618
Charles Nguyen, MD
[email protected]
Charles Nguyen, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jacob Zaemes, MD
[email protected]
Dana-Farber Cancer InstituteBostonMassachusetts02215
Bradley McGregor, MD
[email protected]
University of MichiganAnn ArborMichigan48109
Irene Tsung, MD
[email protected]
UT Southwestern Medical CenterDallasTexas75390
Hans Hammers, M.D., Ph.D.
[email protected]
M D Anderson Cancer CenterHoustonTexas77030
Eric Jonasch, M D
[email protected]
713-563-7232
Eric Jonasch, M D (PRINCIPAL_INVESTIGATOR)

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City of Hope· Irvine, CABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAUniversity of Michigan· Ann Arbor, MIUT Southwestern Medical Center· Dallas, TXM D Anderson Cancer Center· Houston, TX

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