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Renal Cell CarcinomaPhase 3NCT04987203

Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

A Phase 3 study testing Tivozanib and Nivolumab in people with Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 139 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI). Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Tivozanib and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
139 sitesin 16 countries
Study dates
9 Sep 2021to 20 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment.
  • Subjects must have recovered from the adverse events of prior therapy to grade ≤ 1 or baseline.
  • Histologically or cytologically confirmed RCC with a clear cell component.
  • Measurable disease per RECIST criteria Version 1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • All participants must follow protocol defined contraceptive measures.

Who cannot join

  • Subjects who received: a. A single agent tyrosine kinase inhibitor (TKI) in the first line setting followed by a single agent immune checkpoint inhibitor (ICI) in the second line setting; b. More than 2 prior lines of therapy in the advanced or metastatic setting.
  • History of life-threatening toxicity related to prior immune therapy.
  • Active autoimmune disease as well as those that required discontinuation of prior immuno-oncological (IO) therapy due to immune mediated AEs.
  • Uncontrolled hypertension.
  • More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting.
  • Subjects on immune suppressive therapy for organ transplant or subjects with a history of genetic or acquired immune suppression disease such as human immunodeficiency virus (HIV) [Patients with HIV who have CD4+ T-cell counts >350 cells/µL, without a history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections, and are on established antiretroviral therapy which does not include a cytochrome P450 (CYP)3A4 inducer, for at least 4 weeks and have an HIV viral load less than 400 copies/mL, are eligible].
  • History of clinically significant interstitial lung disease or current non-infectious pneumonitis.

Trial locations and contacts

139 sites in 16 countries.

139 sites in 16 countries

United States36 sites

  • University of New Mexico - Comprehensive Cancer Center

    Albuquerque, New Mexico, 87131-0001

  • Lehigh Valley Physician Group

    Allentown, Pennsylvania, 18103-6218

  • Texas Oncology - Central Austin Cancer Center

    Austin, Texas, 78731

  • University of Maryland Medical Center-Greenebaum Cancer Ctr

    Baltimore, Maryland, 21201

  • John Hopkins Medicine - Hematology/oncology

    Baltimore, Maryland, 21287

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102-6746

  • Dana-Farber Cancer Institute - Medicine

    Boston, Massachusetts, 02215

  • Roswell - Roswell Park Cancer Institute - Medical Oncology

    Buffalo, New York, 14263

  • Chattanooga Oncology and Hematology Associates

    Chattanooga, Tennessee, 37404

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001

  • Maryland Oncology Hematology

    Clinton, Maryland, 20735

  • UH Cleveland Medical Center

    Columbia, South Carolina, 29210

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • US Oncology - Rocky Mountain Cancer Centers - Midtown

    Denver, Colorado, 80218-1237

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Memorial Sloan Kettering Cancer Center - Westchester

    East White Plains, New York, 10604

  • Florida Cancer Specialists & Res Inst

    Fort Myers, Florida, 33901

  • Chao Family Comprehensive Cancer Center, UC Irvine

    Irvine, California, 92868

  • University of California San Diego

    La Jolla, California, 92037

  • University of Kentucky UK Markey Cancer Center

    Lexington, Kentucky, 40536

  • Memorial Sloan Kettering Cancer Center - Monmouth - Oncology

    Middletown, New Jersey, 07748-3052

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Tulane Cancer Center Clinic - Oncology

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital

    New York, New York, 10065

  • Oncology Hematology West PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Allegheny General Hospital (AGH)

    Pittsburgh, Pennsylvania, 15212-4756

  • Leland Stanford Junior University

    Redwood City, California, 94063

  • Kaiser Permanente Riverside Medical Center

    Riverside, California, 92505

  • US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center

    San Antonio, Texas, 78240

  • University Of Washington - Medical Center

    Seattle, Washington, 98109

  • Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location

    St. Petersburg, Florida, 33705

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405-5016

  • Memorial Sloan Kettering Cancer Center - Nassau

    Uniondale, New York, 11553

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205-2005

Other trials in United States

France16 sites

  • Hopital Saint-Andre - Service d'Oncologie Medicale

    Bordeaux, Gironde, 33075

  • CHU Michallon - Hopital Nord - Cancérologie Et Hématologie

    Grenoble, Isère, 38043

  • CHD Vendee La Roche sur Yon - Gastro-Entérologie

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo - Hematologie

    Le Mans, Sarthe, 72000

  • Hôpital privé Le Bois

    Lille, Nord, 59000

  • Centre Leon Berard - departement d'oncologie medicale

    Lyon, Rhône, 69373

  • Institut Paoli Calmettes - Hôpital de jour

    Marseille, Bouches-du-Rhône, 13273

  • Centre de Lutte Contre le Cancer (CLCC)

    Nice, 06189

  • Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

  • Centre Hospitalier de Poitiers

    Poitiers, Poitou-Charentes, 86021

  • ICO - Site Rene Gauducheau - Oncologie Medicale

    Saint-Herblain, 44805

  • Institut de cancérologie de Strasbourg Europe - ICANS

    Strasbourg, Alsace, 67200

  • Hopital Foch

    Suresnes, Hauts-de-Seine, 92151

  • Hopital Trousseau - medical oncology

    Tours, 37044

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54511

  • Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Spain16 sites

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Universitario Vall d'

    Barcelona, Barcelona, 08035

  • Institut Catalá d´Oncología (I.C.O.)

    Barcelona, Barcelona, 08908

  • Hospital Del Mar

    Barcelona, Barcelona, 8003

  • H.G.U. de Elche

    Elche, Alicante, 03203

  • ICO-Hospital Universitari de G

    Girona, Girona, 17007

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital U. 12 Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • C.H.U. de Orense

    Ourense, 32005

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitari Parc Tau

    Sabadell, Barcelona, 8208

  • Hospital Universitario Virgen

    Seville, Sevilla, 41009

  • Fundación Instituto Valenciano

    Valencia, Valencia, 46009

  • Hospital Universitario Y Politécnico La Fe

    Valencia, Valenciana, Comunidad, 46026

Other trials in Spain

Italy12 sites

  • Ospedale S.Donato, AUSL 8 di Arezzo

    Arezzo, Arezzo, 52100

  • Azienda Mater Domini

    Catanzaro, Catanzaro, 88100

  • P.O. Ss. Annunziata

    Chieti Scalo, Chieti, 66013

  • PO di Cremona, ASST di Cremona - Oncologia medica

    Cremona

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • IRST

    Meldola (Fc), Forli, 47014

  • European Institute of Oncology

    Milan, Milano, 20141

  • IRCCS Fondazione "Giovanni Pas

    Naples, 80131

  • IRCCS Policlinico San Matteo

    Pavia, Pavia, 27100

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Roma, '00168

  • AO S.Camillo-Forlanini

    Roma, Roma, 00152

  • Azienda Ospedaliera Santa Maria di Terni

    Terni, Terni, 05100

Other trials in Italy

United Kingdom10 sites

  • Addenbrooke's Hospital - Oncology

    Cambridge, Cambridgeshire, CB2 0QQ

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    London, London, City of, W6 8RF

  • The Christie NHS Foundation Trust - Medical Oncology

    Manchester, Manchester, M20 4BX

  • Mount Vernon Cancer Centre

    Northwood, England, HA6 2JW

  • Royal Blackburn Hospital - Oncology

    Preston, Lancashire, PR2 9HT

  • Royal Marsden - Sutton

    Sutton, Surrey, SM2 5PT

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

  • New Cross Hospital

    Wolverhampton, Wolverhampton, WV10 0QP

Other trials in United Kingdom

Poland9 sites

  • Wojewodzki Szpital Specjalistyczny

    Biała Podlaska, 21-500

  • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

    Brzozów, Podkarpackie Voivodeship, 36-200

  • COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

    Gdansk, Pomeranian Voivodeship, 80-219

  • Szpital Specjalistyczny im. L. Rydygiera w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-826

  • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

    Otwock, Masovian Voivodeship, 05-400

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569

  • Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.

    Rzeszów, Podkarpackie Voivodeship, 35-021

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

    Warsaw, 02-507

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Belgium6 sites

  • Institut Jules Bordet - Oncologie Médicale

    Anderlecht, Brussels Capital, 1070

  • CHU Brugmann - Victor Horta

    Brussels, 1020

  • UZ Gent - Medische Oncologie

    Ghent, Oost-Vlaanderen, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

    Hasselt, Limburg, 3500

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • ZNA Jan Palfijn

    Merksen, Antwerpen, 2170

Other trials in Belgium

Brazil6 sites

  • Universidade Estadual de Campi

    Campinas, São Paulo, 13083-970

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Centro Gaucho Integrado de Onc

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Hospital Nossa Senhora da Conc

    Porto Alegre, 90610-000

  • Pontificia Universidade

    Porto Alegre, 90610-000

  • Instituto Brasileiro de Controle do Cancer - ibcc

    São Paulo, São Paulo, 03102-002

Other trials in Brazil

Portugal5 sites

  • H. Prof. Doutor Fernando Fonseca

    Amadora, Lisbon District, 2720-276

  • Hospital Particular do Algarve - Gambelas-Faro

    Faro, Faro District, 8005-226

  • H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

    Lisbon, Lisbon District, 1649-035

  • H. Santo Antonio. Centro Hospitalar do Porto

    Porto, Porto District, 4099-001

  • Instituto Português Oncologia Francisco Gentil do Porto

    Porto, 4200-072

Other trials in Portugal

Argentina4 sites

  • Centro Oncológico Korben

    Buenos Aires, Ciudad Autónoma de Buenos Aire, C1280AEB

  • Centro Oncologico de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Centro para la Atención Integral del paciente Oncológico

    San Miguel de Tucumán, Tucumán Province, T4000GTB

  • Clínica Viedma

    Viedma, Río Negro Province, R8500JYJ

Other trials in Argentina

Australia4 sites

  • Mater Misericordiae Limited

    Brisbane, Queensland, 4101

  • Sunshine Hospital

    Geelong, Victoria, 3220

  • Liverpool Hospital Cancer Therapy Centre

    Liverpool, New South Wales, 2170

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Sunnybrook Research Institute, sunnybrook Health Sciences Ct

    Toronto, Ontario, M4N 3M5

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Chile4 sites

  • Centro de Estudios Clinicos In

    Santiago, Región Metropolitana de Santia, 8420383

  • Centro de Estudios Clínicos SAGA SpA

    Santiago, Región Metropolitana de Santia

  • Meditek Ltda.

    Santiago, Santiago Metropolitan, 8420383

  • ACEREY Centro de Investigación Clínica Oncológica

    Viña del Mar, Valparaiso, 2520612

Other trials in Chile

Czechia4 sites

  • University Hospital Brno

    Brno, Brno-město, 625 00

  • FN Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 140 59

  • FN Kralovske Vinohrady

    Prague, 100 34

Other trials in Czechia

Germany2 sites

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

Other trials in Germany

Mexico1 site

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Tlalpan, 14080

Other trials in Mexico

About this study

Official title: TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

Read the detailed description

This will be an open-label, randomized, controlled, multicenter, multi-national, parallel-arm study. The study is designed to compare the progression free survival (PFS), overall survival (OS), Objective response rate (ORR), duration of response (DoR), and safety of tivozanib and the combination of tivozanib with nivolumab.

Approximately 326 subjects with refractory advanced RCC at approximately 190 sites will be randomized in a 1:1 ratio to treatment with tivozanib plus nivolumab (163 subjects) or tivozanib (163 subjects). Subjects will be randomly assigned to a treatment.

Subjects will receive 1.34 mg/day (monotherapy arm) or 0.89mg/day (combination arm) of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug. One cycle will be defined as 4 weeks: 3 weeks on treatment and 1 week off treatment. Subjects who receive nivolumab will be infused with 1 treatment of nivolumab at specified dose on specified days of each Cycle.

Subjects with documented stable disease or an objective response may continue to receive both tivozanib and nivolumab therapy at the same dose and schedule until progression as long as the tolerability is acceptable. Nivolumab will be discontinued in all subjects after 2 years; Tivozanib may be continued after discontinuation of nivolumab until other withdrawal criteria are met. A Safety Follow-up Visit will be performed 30 days (± 7 days) after the last dose of study drug.

Being tested
Tivozanib, Nivolumab
Keywords
Immune Checkpoint Inhibitor, Open-label, Monotherapy, Disease Progression
Medical subject headings
Carcinoma, Renal Cell, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TivozanibDrug

    Tivozanib will be administered orally.

  • NivolumabDrug

    Nivolumab will be administered via intravenous infusion.

Study groups in NCT04987203
Study groupRoleWhat they receive
Tivozanib in Combination with NivolumabExperimentalSubjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment [for nivolumab] whichever occurs first.
Receives: Drug: Tivozanib; Drug: Nivolumab
TivozanibExperimentalSubjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.
Receives: Drug: Tivozanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Comparison of the PFS of tivozanib in combination with nivolumab to tivozanib in subjects with RCC who have progressed following 1 or 2 lines of therapy. PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to Response Evaluation Criteria In Solid Tumors (RECIST), or death due to any reasons whichever comes first.

    Measured: Until progressive disease [PD] (Approximately 30 months)

Secondary outcomes (5)

  1. Overall Survival

    Comparsion of the OS of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. OS is defined as the time from the date of randomization to date of death due to any cause.

    Measured: From Screening (Days -28 to -1) until death (Approximately 42 months)

  2. Progression free survival

    PFS is defined as the time from randomization to first documentation of objective tumor progression (progressive disease [PD], radiological) according to RECIST, or death due to any reasons whichever comes first. PFS as assessed by investigator.

    Measured: Until progressive disease [PD] (Approximately 30 months)

  3. Objective Response Rate

    Comparison of ORR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. ORR is defined as the proportion of subjects with confirmed complete response or confirmed partial response according to RECIST relative to the total population of randomized subjects.

    Measured: From Screening (Days -28 to -1) until PD (Approximately 30 months)

  4. Duration of Response

    Comparison of DoR of subjects randomized to treatment with tivozanib in combination with nivolumab compared to tivozanib. DoR is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause.

    Measured: From Screening (Days -28 to -1) until PD or death (Approximately 30 months)

  5. Number of subjects with serious and non-serious adverse events

    Assessment of the safety and tolerability of tivozanib in combination with nivolumab compared to tivozanib.

    Measured: From Screening (Day -28 to Day -1) to Follow-up visit (30 days after last dose of study drug ± 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start9 Sep 2021
  3. Primary completion20 Jan 2026
  4. Study completion20 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04987203
Sponsor's protocol ID
AV-951-20-304
Status last verified
May 2026
First submitted
23 Jul 2021
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Choueiri TK, Albiges L, Barthelemy P, Iacovelli R, Emambux S, Molina-Cerrillo J, Garmezy B, Barata P, Basu A, Bourlon MT, Moon H, Ratta R, McKay RR, Chehrazi-Raffle A, Hammers H, Heng DYC, Braendle E, Beckermann KE, McGregor BA, Motzer RJ. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study. Lancet. 2024 Oct 5;404(10460):1309-1320. doi: 10.1016/S0140-6736(24)01758-6. Epub 2024 Sep 13.

    PubMed 39284329

  • Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.

    PubMed 35304832

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tivozanib and Nivolumab in people with Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 139 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 139 sites in United States, France, Spain, Italy, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: Until progressive disease [PD] (Approximately 30 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04987203, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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