NCT06053658

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started Jan 2024

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2024Nov 2028

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 5, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 19, 2023

Last Update Submit

April 13, 2026

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    through study completion; average of 1 year

Study Arms (1)

Combination Tivozanib and Nivolumab

EXPERIMENTAL

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.

Drug: TivozanibDrug: Nivolumab

Interventions

NivolumabDRUG

Given by IV (vein)

Also known as: Opdivo, BMS-936558
Combination Tivozanib and Nivolumab
TivozanibDRUG

Given by PO

Also known as: KRN 951, KRN-951, KRN951, UNII-172030934T, AV951, AV951 cpd
Combination Tivozanib and Nivolumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically or cytologically confirmed metastatic non-clear cell renal cell carcinoma of papillary, chromophobe, oncocytic neoplasms, unclassified, or not otherwise specified (NOS) as clear cell. Medullary carcinoma of the kidney and collecting duct tumors are NOT allowed
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Up to 1 systemic line of therapy (either monotherapy or combination) including prior immunotherapy (anti-PD1, PD-L1, or CTLA-4) and multi-tyrosine kinase inhibitors in non-metastatic or metastatic setting is allowed. A washout period of 5 half lives or 21 days, whichever one is shorter, will be required for patients that have received previous systemic therapy.
  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) Appendix 1 performance status ≤2 (Karnofsky ≥60%).
  • Patients must have adequate organ and marrow function as defined below:
  • absolute neutrophil count ≥1,000/mcL
  • platelets ≥100,000/mcL
  • total bilirubin ≤ institutional upper limit of normal (ULN)
  • AST ≤3 × institutional ULN
  • (ALT) ≤3 × institutional ULN
  • creatinine ≤1.5 × institutional ULN
  • eGFR ≥30 ml/min
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • +11 more criteria

You may not qualify if:

  • Prior tivozanib therapy.
  • Prior nivolumab therapy.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
  • Patients who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or nivolumab.
  • Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 2 hours apart. Anti-hypertensives must not have been increased 30 days prior to enrollment.
  • History of autoimmune disorders except for the following:
  • Patients with vitiligo or alopecia
  • Hypothyroidism (e.g. following Hashimoto syndrome) that is stable on thyroid hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active autoimmune disease requiring treatment in the last 3 years may be included after consultation with study MDA lead Principal Investigator
  • Active human immunodeficiency virus (HIV) infection unless patients are on effective anti-retroviral therapy with undetectable viral load within 6 months.
  • Has evidence of any other medical conditions, psychiatric condition, physical examination or laboratory findings that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications in the opinion of the local principal investigator (PI).
  • Current systemic corticosteroid use greater than prednisone 10 mg daily or equivalent.
  • Pregnant women are excluded from this study because tivozanib and nivolumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tivozanib and nivolumab, breastfeeding should be discontinued if the mother is treated with tivozanib and nivolumab.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

tivozanibNivolumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Eric Jonasch, M D

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Jonasch, M D

CONTACT

(713) 563-7232ejonasch@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

January 5, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

US(5)