The TiNivo-2 clinical trial is open for enrollment.

This trial will test a new combination therapy for advanced renal cell carcinoma (aRCC).

TiNivo-2 is a
Phase 3 clinical trial

It is the first of its kind to evaluate the safety and efficacy of a unique combination therapy for advanced renal cell carcinoma (aRCC)1

This trial aims to enroll over 300 patients across nearly 200 clinical sites to compare the effects of the most recently approved tivozanib, an oral tyrosine kinase inhibitor (TKI), in combination with nivolumab, an immunotherapy, versus tivozanib alone.1,2


The TiNivo-2 trial is open and actively recruiting patients

For patients:
TiNivo-2: Testing a unique combination of two FDA-approved medicines for advanced renal cell carcinoma (aRCC)*

If you are a patient with aRCC, you may be eligible for the TiNivo-2 trial. This clinical study aims to find out if two medicines approved for aRCC, tivozanib, a tyrosine kinase inhibitor (TKI), and nivolumab, an immunotherapy, might be more beneficial than tivozanib alone. The trial will also make sure that both medicines taken together continue to be safe (based on the TiNivo trial safety data).

What is the TiNivo-2 trial testing?

The TiNivo-2 trial will test if taking tivozanib, a tyrosine kinase inhibitor (TKI), and nivolumab, an immunotherapy, in people with advanced renal cell carcinoma (aRCC) might be more effective than taking tivozanib alone.

People in this study will be divided into two groups. One group will take tivozanib and one group will take tivozanib and nivolumab together. Tivozanib is taken by mouth and nivolumab is taken through an IV. Researchers will test the effects of taking one medicine compared to two medicines on treatment response and safety.

Interested in participating? Learn more >>

Reference
ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203

What medicines might I receive?

In the TiNivo-2 trial, you will either receive tivozanib, a tyrosine kinase inhibitor (TKI), and nivolumab, an immunotherapy, together or tivozanib alone. There is no placebo group in this trial; all patients will receive active treatment.1

Tyrosine kinases are substances in the body that are important for cell growth. In cancer cells, the levels of these substances are too high. TKI medicines work by blocking these substances to help keep cancer cells from growing.2

Immunotherapies work differently from TKIs. These medicines boost your body’s natural immune system to help your body fight cancer.3

Both of these medicines have been approved by the FDA to treat advanced renal cell carcinoma (aRCC).4,5*

Reference

  1. ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203
  2. National Cancer Institute. Tyrosine Kinase Inhibitor. Accessed December 21, 2021. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/tyrosine-kinase-inhibitor
  3. National Cancer Institute. Immunotherapy. Accessed December 21, 2021. https://www.cancer.gov/search/results?swKeyword=immunotherapy
  4. FOTIVDA (tivozanib) [package insert]. Boston, MA: AVEO Pharmaceuticals, Inc, March 2021.
  5. OPDIVO (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company, March 2022.

What should I expect in this trial?

A clinical trial is a type of study where researchers test if certain treatments, like new medicines, are effective and safe. Participating in cancer clinical trials can help move research forward so there are more medicines available for patients like you.1

Sometimes in clinical trials, one group receives an inactive treatment called placebo. But, in the TiNivo-2 trial, every patient will receive an FDA-approved therapy for advanced renal cell carcinoma (aRCC).2-4* Some people will take tivozanib, a tyrosine kinase inhibitor (TKI), and nivolumab, an immunotherapy, together or tivozanib alone.2

The sponsor of a clinical trial typically pays for the costs of medicines. While insurance coverage varies, there may be no or low out-of-pocket costs while you are participating in the trial.

Reference

  1. National Cancer Institute. What are clinical trials? Accessed December 21, 2021. https://www.cancer.gov/about-cancer/treatment/clinical-trials/what-are-trials
  2. ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203
  3. FOTIVDA (tivozanib) [package insert]. Boston, MA: AVEO Pharmaceuticals, Inc, March 2021.
  4. OPDIVO (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company, March 2022.

Am I eligible for this trial?

Every clinical trial has inclusion and exclusion criteria, meaning that only certain people can enroll because of the types of patients the researchers want to study.

To be eligible for the TiNivo-2 trial, patients must have locally advanced or metastatic renal cell carcinoma (RCC) and had their cancer progress after no more than 1 or 2 prior lines of therapy. Patients must have received an immunotherapy as part of their previous line of treatment.

Patients must also be 18 years or older and be active enough to participate.

People who have taken more than 2 lines of therapy, have an autoimmune disease, or have uncontrolled high blood pressure are not eligible for the study.

See additional criteria for this study >>

Reference
ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203

How do I enroll in the trial?

If you are interested in this trial and think you might be a good fit, talk to your doctor. They can review the trial with you and help you better understand all of the details of the study. Your doctor can also determine if you might meet the criteria for enrollment.

Reach out to your doctor or contact AVEO Clinical Development:

(857) 400-0101
clinical@aveooncology.com

You can tell them that you are interested in this specific trial number:
NCT04987203

Where are the clinical trial sites?

Here are the locations of the sites that are recruiting patients now:

Genesis Cancer and Blood Institute
Hot Springs, Arkansas 71913

University of California San Diego
La Jolla, California 92037

Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140

NorthShore University Health System
Evanston, Illinois 60201

University of Kentucky UK Markey Cancer Center
Lexington, Kentucky 40536

Tulane Cancer Center Clinic – Oncology
New Orleans, Louisiana 70112

University of Maryland Medical Center Greenebaum Cancer Center
Baltimore, Maryland 21201

Henry Ford Hospital
Detroit, Michigan 48202

St. Vincent Frontier Cancer Center
Billings, Montana 59102-6746

Nebraska Cancer Center
Omaha, Nebraska 68130

Oncology Hematology West PC dba
Nebraska Cancer Specialists

Omaha, Nebraska 68130

Memorial Sloan Kettering Cancer Center – Basking Ridge – Oncology
Basking Ridge, New Jersey 07920

Memorial Sloan Kettering Cancer Center – Monmouth – Oncology
Middletown, New Jersey 07748-3052

Memorial Sloan Kettering Cancer Center – Bergen – Oncology
Montvale, New Jersey 07645

University of New Mexico – Comprehensive Cancer Center
Albuquerque, New Mexico 87131-0001

Memorial Sloan Kettering Cancer Center – Commack
Commack, New York 11725

Memorial Sloan Kettering Cancer Center – Westchester
Harrison, New York 10604

Memorial Sloan Kettering Cancer Center (MSKCC) – Memorial Hospital
New York, New York, 10065

Stony Brook University Cancer Clinical Trials
Stony Brook, New York 11794

Memorial Sloan Kettering Cancer Center – Nassau
Uniondale, New York 11553

Cleveland Clinic
Cleveland, Ohio 44195-0001

Fox Chase Cancer Center – Medical Oncology
Philadelphia, Pennsylvania 19111-2497

Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee 37404

Baptist Cancer Center
Memphis, Tennessee 38120

Tennessee Oncology, PLLC
Nashville, Tennessee 37203

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232

Inova Schar Cancer Institute – Medical Oncology
Fairfax, Virginia 22031

University Of Washington – Medical Center
Seattle, Washington, 98109

Northwest Medical Specialties PLLC Recruiting
Tacoma, Washington 98405-5016

Check here often. New sites will be added soon.

View the clinical trial page for TiNivo-2 to see the latest sites >>

Talk to your doctor about this trial

Your doctor can review the eligibility criteria and help you determine if this trial might be a good fit for you.

If you’d like to learn more, please contact AVEO Oncology:

(857) 400-0101 clinical@aveooncology.com

For clinicians:
TiNivo-2: An innovative Phase 3 trial in
advanced renal cell carcinoma (aRCC)1

This large-scale trial will assess the safety and efficacy of a tivozanib-nivolumab combination compared
with tivozanib alone for aRCC.1,2 Endpoints will include progression-free survival, overall survival, objective
response rate, duration of response, and safety.1,2

Patients with aRCC may be eligible for the trial if they have received 1 or 2 prior lines of therapy,
including an immune checkpoint inhibitor (ICI).

Get more information about this trial >>

The Science Behind
the Study

Learn more >>

Study Design & Eligibility
Criteria

Learn more >>

Trial Sites

Learn more >>

Learn more about TiNivo-2

If you have any questions about the trial or are interested in participating or enrolling patients, contact AVEO Clinical Development:
(857) 400-0101 clinical@aveooncology.com

The clinical trial identified is NCT0498720.

*On March 10, 2021, the FDA approved tivozanib for adult patients with relapsed or refractory aRCC following 2 or more prior systemic therapies.2 On November 23, 2015, the FDA approved nivolumab for patients with aRCC who have received prior anti‐angiogenic therapy.3

References

  1. ClinicalTrials.gov. Study to compare tivozanib in combination with nivolumab to tivozanib monotherapy in subjects with renal cell carcinoma. Accessed December 21, 2021. https://clinicaltrials.gov/ct2/show/NCT04987203
  2. FOTIVDA (tivozanib) [package insert]. Boston, MA: AVEO Pharmaceuticals, Inc, March 2021.
  3. OPDIVO (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company, March 2022.