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Biliary Tract CancerPhase 3NCT04163900

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

A Phase 3 study testing NUC-1031, Gemcitabine and Cisplatin in people with Biliary Tract Cancer, run by NuCana plc at 125 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care The… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
NUC-1031, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
773 participants
Where
125 sitesin 15 countries
Study dates
24 Dec 2019to 5 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent and authorization to use and disclose health information.
  • Ability to comprehend and willingness to comply with the requirements of this protocol, including the QoL questionnaires.
  • Female or male patients aged ≥18 years.
  • Histologically- or cytologically-confirmed adenocarcinoma of the biliary tract (including gallbladder, intra and extra-hepatic biliary ducts and ampullary cancers) that is locally advanced, unresectable or metastatic (AJCC edition 8, 2018). Patients with measurable (as per RECIST v1.1 criteria) or non-measurable disease are permitted.
  • Life expectancy ≥16 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Show all 19Show fewer
  • Adequate biliary drainage with no evidence of ongoing infection. If applicable, treatable and clinically-relevant biliary duct obstruction has been relieved by internal endoscopic drainage/stenting at least 2 weeks previously or by palliative bypass surgery or percutaneous drainage prior to study treatment, and the patient has no active or suspected uncontrolled infection. Patients fitted with a biliary stent should be clinically stable and free of signs of infection for ≥2 weeks prior to study treatment. Patients with improving biliary function who meet all other inclusion criteria may be re-tested during the screening window.
  • Adequate bone marrow, hepatic, and renal function, as evidenced by:
  • Absolute neutrophil count (ANC) ≥1,500/μL without colony-stimulating factor support
  • Platelet count ≥100,000/μL
  • Haemoglobin ≥9 g/dL without need for haematopoietic growth factor or transfusion support in prior 2 weeks
  • Total bilirubin <2 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome. Consistent with inclusion criterion 7, patients whose whole bilirubin and biliary function is recovering may be re-tested during the screening period.
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <5 × ULN
  • Creatinine clearance ≥45 mL/min actual or calculated by the Cockcroft-Gault method
  • International normalized ratio (INR) <1.5 and activated partial thromboplastin time (aPTT) <1.5 × ULN; does not apply to patients on an anti-coagulant with stable dose 28 days prior to first dose.
  • QTc interval <450 msec (males) or <470 msec (females), in the absence of bundle branch block. In the presence of bundle branch block with consequent QTc prolongation, patients may be enrolled based on a careful risk-benefit assessment.
  • Human Immunodeficiency Virus-infected patients who are healthy and have a low risk of Acquired Immunodeficiency Syndrome-related outcomes may be included in this study.
  • Female patients of child-bearing potential (i.e., all women except those who are post-menopausal for ≥1 year or who have a history of hysterectomy or surgical sterilization) must have a negative pregnancy test within 3 days prior to the first study drug administration. All patients of child-bearing potential must agree to practice true abstinence or to use two highly effective forms of contraception, one of which must be a barrier method of contraception, from the time of screening until 6 months after the last dose of study medication.
  • Male patients with a female partner must either have had a successful vasectomy or they and their female partner meet the criteria above (not of childbearing potential or practicing highly effective contraceptive methods).

Who cannot join

  • Combined or mixed hepatocellular/cholangiocarcinoma.
  • Prior systemic therapy for advanced or metastatic biliary tract cancer. However, prior chemotherapy in the adjuvant setting or low-dose chemotherapy given in conjunction with radiotherapy in the adjuvant setting and completed at least 6 months prior to enrolment is permitted. The following prior interventions are allowed provided the patient has fully recovered:
  • Surgery: non-curative resection with macroscopic residual disease or palliative bypass surgery. Patients who have previously undergone curative surgery must now have evidence of non-resectable disease requiring systemic chemotherapy.
  • Radiotherapy: prior radiotherapy (with or without radio-sensitizing low-dose chemotherapy) for localized disease and there is now clear evidence of disease progression requiring systemic chemotherapy.
  • Photodynamic therapy: prior photodynamic therapy for localized disease with no evidence of metastatic disease or for localized disease to relieve biliary obstruction in the presence of metastatic disease provided there is now clear evidence of disease progression requiring systemic chemotherapy.
  • Palliative radiotherapy: palliative radiotherapy provided that all adverse events have resolved and the patient has measurable disease outside the field of radiation.
Show all 19Show fewer
  • Prior treatment with or known hypersensitivity to NUC-1031, gemcitabine, cisplatin or other platinum-based agents or history of allergic reactions attributed to any parenteral excipients (e.g. dimethylacetamide [DMA], Cremophor EL, Polysorbate 80, Solutol HS 15).
  • Symptomatic central nervous system or leptomeningeal metastases.
  • History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, surgically excised or potentially curatively treated ductal carcinoma in situ of the breast, or low grade prostate cancer or patients after prostatectomy not requiring treatment. Patients with previous invasive cancers are eligible if treatment was completed more than 3 years prior to initiating the current study treatment, and the patient has had no evidence of recurrence since then.
  • Concurrent serious (as deemed by the Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.
  • Congenital or acquired immunodeficiency (e.g., serious active infection with HIV). As per inclusion criterion 10, patients with HIV who are healthy and have a low risk of AIDS related outcomes are eligible.
  • Other acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
  • Prior exposure to another investigational agent within 28 days prior to randomization.
  • Major surgery within 28 days prior to randomization; patient must have completely recovered from any prior surgical or other procedures.
  • Pregnant or breastfeeding.
  • Residual toxicities from prior treatments or procedures which have not regressed to Grade ≤1 severity (CTCAE v5.0), except for alopecia or ≤ Grade 2 peripheral neuropathy.
  • Concomitant use of drugs at doses known to cause clinically relevant prolongation of QT/QTc interval.
  • Administration of a live vaccination within 28 days prior to randomization.
  • Ongoing or recent (≤6 months) hepatorenal syndrome.

Trial locations and contacts

125 sites in 15 countries.

125 sites in 15 countries

United States29 sites

  • Rocky Mountain Cancer Centers, LLP- Aurora

    Aurora, Colorado, 80012

  • Texas Oncology, P.A. - Austin

    Austin, Texas, 78705

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215-5400

  • Affiliated Oncologists LLC

    Chicago Ridge, Illinois, 60415

  • IACT Health

    Columbus, Georgia, 31904

  • The Ohio State University James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Medical Group

    Detroit, Michigan, 48202

  • Prisma Health Upstate

    Greenville, South Carolina, 29605

  • Norton Cancer Institute

    Louisville, Kentucky, 40217

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Baptist Health Medical Group Oncology, LLC

    Miami, Florida, 33176

  • The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • Minnesota Oncology Hemtology

    Minneapolis, Minnesota, 55404

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455

  • Orlando Health, Inc.

    Orlando, Florida, 32806

  • Corporal Michael J. Crescenz VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Rochester Medical Center - Strong Memorial Hospital

    Rochester, New York, 14642

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • The Research Foundation for The State University of New York

    Stony Brook, New York, 11794-3369

  • Arizona Oncology Associates , PC - HOPE

    Tucson, Arizona, 85711

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.-Vancouver

    Vancouver, Washington, 98684

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • University of Kansas Medical Center Research Institute, Inc.

    Westwood, Kansas, 66205

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602-3171

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

South Korea10 sites

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

  • Dong-A University Hospital

    Pusan, 602-715

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Severance Hospital, Yonsei University

    Seoul, 3722

  • Asan Medical Center

    Seoul, 5505

Other trials in South Korea

Australia9 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Warringal Medical Centre

    Heidelberg, Victoria, 3084

  • St George Hospital

    Kogarah, New South Wales, 2217

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Newcastle Private Hospital

    Newcastle, New South Wales, 2305

  • Townsville Cancer Centre

    Townsville, Queensland, 4814

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain9 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario HM Madrid Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Canada8 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H1V7

  • CHUM Centre de Recherche

    Montreal, Quebec, H2X 0A9

  • SMBD Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X6

Other trials in Canada

Ukraine8 sites

  • CI Chernivtsi RC Oncological Dispensary

    Chernivtsi, 58013

  • Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv NMU

    Kharkiv, 61070

  • CI of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

    Kharkiv, 61166

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115

  • SI "Shalimov's National Institute of Surgery and Transplantation" of NAMSU

    Kyiv, 03126

  • Treatment-Prevention Institution Volyn Regional Oncological Dispensary

    Lutsk, 43018

  • Communal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40022

Other trials in Ukraine

Russia7 sites

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, 115478

  • FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin

    Moscow, 115478

  • "VitaMed" LLC

    Moscow, 129515

  • State Budget Institution of Healthcare "Leningrad Regional Clinical Oncology Dispensary"

    Saint Petersburg, 191104

  • Pavlov First Saint Petersburg State Medical University

    Saint Petersburg, 197022

  • SPb SBIH "City Clinical Oncological Dispensary"

    Saint Petersburg, 197022

  • Medicinskiy gorod

    Tyumen, 625041

Other trials in Russia

Turkey (Türkiye)7 sites

  • Acibadem Adana Hospital

    Adana, 01130

  • Baskent University Adana Application and Research Center

    Adana, 01220

  • Akdeniz University Medical Faculty

    Antalya, 07058

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Malatya, 06105

  • Inonu University Medical Facility

    Malatya, 44280

Other trials in Turkey (Türkiye)

Hungary6 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem

    Debrecen, 4032

  • Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

    Miskolc, 3526

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 5004

Other trials in Hungary

Italy6 sites

  • Ospedale Policlinico San Martino

    Genova, 16132

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

  • IOV - Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Centro Ricerche Cliniche di Verona S.r.l

    Verona, 37124

Other trials in Italy

United Kingdom6 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 OYN

  • Guy's Hospital

    London, Greater London, SE1 9RY

  • The Christie

    Manchester, Greater Manchester, M20 4BX

  • The Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

  • Torbay Hospital

    Torquay, TQ2 7AA

Other trials in United Kingdom

Czechia5 sites

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní nemocnice Olomouc

    Olomouc, 775 20

  • Thomayerova nemocnice

    Prague, 140 59

  • Nemocnice Na Homolce

    Prague, 150 30

Other trials in Czechia

France5 sites

  • Centre Georges François Leclerc

    Dijon, 21079

  • CHU de Grenoble - Hôpital Nord

    Grenoble, 38043

  • Institut Hospitalier Franco-Britannique

    Levallois-Perret, 92300

  • Hôpital Cochin

    Paris, 75679

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805

Other trials in France

Germany5 sites

  • Vivantes Klinikum Neukoelln

    Berlin, 12351

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

Other trials in Germany

Taiwan5 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 50004

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10016

  • MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

  • The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
  • The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
Being tested
NUC-1031, Gemcitabine, Cisplatin
Keywords
Adenocarcinoma, Ampullary, Antineoplastic Agents, Biliary Tract Cancer, Chemotherapy, Cholangiocarcinoma, Cisplatin, Digestive System Neoplasms, Distal Bile Duct, Extrahepatic, First-line Chemotherapy, Gallbladder, Gastrointestinal, Gemcitabine, Hepatobiliary, Intrahepatic, Locally advanced, Metastatic, Neoplasm, NUC-1031
Medical subject headings
Biliary Tract Neoplasms, Adenocarcinoma, Cholangiocarcinoma, Digestive System Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

  • NUC-1031Drug

    Also called fosgemcitabine palabenamide

    IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes

  • GemcitabineDrug

    Also called Difluorodeoxycytidine, Gemzar

    IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert

  • CisplatinDrug

    Also called CDDP

    IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

Study groups in NCT04163900
Study groupRoleWhat they receive
A - NUC-1031 and cisplatinExperimental725 mg/m^2 NUC-1031 administered in combination with 25 mg/m^2 cisplatin on Days 1 and 8 of a 21-day cycle
Receives: Drug: NUC-1031; Drug: Cisplatin
B - gemcitabine and cisplatinActive comparator1000 mg/m^2 gemcitabine administered in combination with 25 mg/m^2 cisplatin on Days 1 and 8 of a 21-day cycle
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Objective Response Rate (ORR)

    Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.

    Measured: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.

  2. Overall Survival (OS)

    The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive.

    Measured: From the date of randomization until the date of death from any cause, assessed up to 12 months on average

Timeline

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

  1. First posted15 Nov 2019
  2. Study start24 Dec 2019
  3. Primary completion2 Mar 2022
  4. Study completion5 Apr 2022

Why it stopped: A pre-planned futility analysis concluded that NUC-1031 plus cisplatin was unlikely to achieve its primary objective of improving overall survival. Based on the IDMC's recommendation, NuCana has closed the study.

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
Model description
1:1 randomization model to either Arm A or Arm B
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
773 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163900
Sponsor's protocol ID
NuTide:121
Other IDs
2019-001025-28, 2019
Status last verified
May 2023
First submitted
1 Nov 2019
Last updated
24 May 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Knox JJ, McNamara MG, Bazin IS, Oh DY, Zubkov O, Breder V, Bai LY, Christie A, Goyal L, Cosgrove DP, Springfeld C, Sjoquist KM, Park JO, Verdaguer H, Braconi C, Ross PJ, De Gramont A, Shroff RT, Zalcberg JR, Palmer DH, Smith JR, Oelmann E, Bruce T, Valle JW. A phase III randomized study of first-line NUC-1031/cisplatin vs. gemcitabine/cisplatin in advanced biliary tract cancer. J Hepatol. 2025 Aug;83(2):358-366. doi: 10.1016/j.jhep.2025.01.040. Epub 2025 Feb 18.

    PubMed 39978598

  • McNamara MG, Goyal L, Doherty M, Springfeld C, Cosgrove D, Sjoquist KM, Park JO, Verdaguer H, Braconi C, Ross PJ, Gramont A, Zalcberg JR, Palmer DH, Valle JW, Knox JJ. NUC-1031/cisplatin versus gemcitabine/cisplatin in untreated locally advanced/metastatic biliary tract cancer (NuTide:121). Future Oncol. 2020 Jun;16(16):1069-1081. doi: 10.2217/fon-2020-0247. Epub 2020 May 6.

    PubMed 32374623

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NUC-1031, Gemcitabine and Cisplatin in people with Biliary Tract Cancer, run by NuCana plc at 125 sites in 15 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 19 inclusion and 19 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: stopped early, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, South Korea, Australia, Spain, Canada and 10 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?

Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.). The study lists 2 primary outcomes in all. 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 NCT04163900, 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 24 May 2023.

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