Actively Recruiting
Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
48
Participants Needed
5
Research Sites
251 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
AVEO Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if giving tivozanib in combination with nivolumab can help to control advanced nccRCC.
CONDITIONS
Official Title
Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or NOS clear cell types
- Measurable disease per RECIST v1.1
- Up to 1 prior systemic therapy allowed with required washout period
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Adequate organ and marrow function based on specified laboratory values
- Treated or controlled hepatitis C or B infections
- Treated brain metastases with no progression or stable active brain metastases if no immediate treatment needed
- Prior or concurrent malignancy not interfering with study
- Cardiac function class 2B or better by NYHA classification
- Agreement to use effective contraception for women of child-bearing potential and men
- Signed informed consent
You will not qualify if you...
- Prior therapy with tivozanib or nivolumab
- Unresolved adverse events from prior cancer therapy greater than Grade 1 except alopecia
- Concurrent use of other investigational agents
- Allergic reactions to similar compounds
- Uncontrolled hypertension (>150/100 mmHg on 2+ medications)
- Active autoimmune disorders except stable vitiligo, alopecia, hypothyroidism, or non-systemic skin conditions
- Active HIV infection without effective treatment
- Other medical, psychiatric, or laboratory conditions risking safety or compliance
- Current systemic corticosteroids over prednisone 10 mg daily or equivalent
- Pregnant or breastfeeding women
- Use of CYP3A inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric Jonasch, M D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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