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Biliary Tract CancerPhase 2/3NCT04066491

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

A Phase 2/3 study testing M7824, Gemcitabine and Cisplatin in people with Biliary Tract Cancer and Cholangiocarcinoma, run by EMD Serono Research & Development Institute, Inc. at 99 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

Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
M7824, Gemcitabine and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
309 participants
Where
99 sitesin 15 countries
Study dates
20 Sep 2019to 10 Nov 2022
Phase
Phase 2/3
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

  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC
  • Participants must have available tumor tissue (primary or metastatic) (archival or fresh biopsies) before the first administration of study treatment
  • At least 1 measurable lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing
  • Life expectancy of >= 12 weeks, as judged by the Investigator
  • Adequate hematological function, hepatic function, renal function, coagulation function as defined in the protocol
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals
  • Other protocol defined inclusion criteria could apply

Who cannot join

  • Previous and/or intercurrent cancers
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
  • Participants with symptomatic central nervous system (CNS) metastases
  • Significant acute or chronic infection including known history of positive test for human immunodeficiency virus (HIV), active tuberculosis, uncontrolled biliary infection and active bacterial or fungal infection requiring systemic therapy (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 Day 1 prior to dosing.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • History of or concurrent interstitial lung disease
Show all 10Show fewer
  • History of hypersensitivity reactions to bintrafusp alfa, anaphylaxis, or recent (within 5 months) uncontrolled asthma, cardiovascular/cerebrovascular disease
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization
  • Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints)
  • Other protocol defined exclusion criteria could apply

Trial locations and contacts

99 sites in 15 countries.

99 sites in 15 countries

United States12 sites

  • Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21287

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Ironwood Cancer & Research Centers - Chandler II

    Chandler, Arizona, 85224

  • Methodist Transplant Physicians

    Dallas, Texas, 75203

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • MD Anderson Cancer Center - Unit 429

    Houston, Texas, 77030

  • Mayo Clinic in Florida - Department of Neurology

    Jacksonville, Florida, 32224

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Renovatio Clinical - CENTRAL SITE

    The Woodlands, Texas, 77380

  • University of Kansas Medical Center Research Institute, Inc. - University of Kansas Cancer Center/Bloch Pavilion

    Westwood, Kansas, 66216

Other trials in United States

China10 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chao Yang Hospital

    Beijing

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • West China Hospital, Sichuan University

    Chengdu

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Fudan University Shanghai Cancer Hospital

    Shanghai

  • The Second Affiliated Hospital of Soochow University

    Suzhou

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

Other trials in China

Japan10 sites

  • Chiba Cancer Center

    Chiba

  • National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

    Chūōku

  • NHO Kyushu Cancer Center - Dept of Gastroenterology/Hepatology/Pancreatology

    Fukuoka

  • National Cancer Center Hospital East

    Kashiwa-shi

  • Cancer Institute Hospital of JFCR - Dept of Hepato,Biliary and Pancreatic Medicine

    Kōtoku

  • Kyorin University Hospital

    Mitaka-shi

  • Aichi Cancer Center Hospital

    Nagoya

  • Osaka City University Hospital

    Osaka

  • Kindai University Hospital

    Osakasayama-shi

  • Kanagawa Cancer Center

    Yokohama

Other trials in Japan

Spain10 sites

  • Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

    Barcelona

  • Hospital Universitari Vall d'Hebron - Dept of Oncology

    Barcelona

  • Hospital San Pedro de Alcantara - Servicio de Oncologia

    Cáceres

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba

  • ICO l´Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat

  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

    Madrid

  • Hospital Universitario Clinico San Carlos - Servicio de Oncologia

    Madrid

  • Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

    Madrid

  • Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

    Valencia

  • Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

    Valencia

Other trials in Spain

South Korea9 sites

  • Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

    Daejeon

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul

Other trials in South Korea

Argentina7 sites

  • Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

    Ciudad Autonoma Buenos Aires

  • Instituto de Investigaciones Metabolicas (IDIM)

    Ciudad Autonoma Buenos Aires

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma Buenos Aires

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja

  • CEDIT

    Salta

  • Centro Medico San Roque S.R.L.

    San Miguel de Tucumán

  • Fundacion ARS Medica

    San Salvador de Jujuy

Other trials in Argentina

Taiwan7 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

Brazil6 sites

  • Hospital de Câncer de Barretos - Fundação Pio XII

    Barretos

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

    Santo André

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    Sao Jose Rio Preto

  • A. C. Camargo Cancer Center

    São Paulo

  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo

Other trials in Brazil

Chile5 sites

  • IC la serena Research

    La Serena

  • Centro de Investigación Clínica Bradford Hill

    Santiago

  • Hospital Clínico Universidad de Chile

    Santiago

  • Prosalud

    Santiago

  • Instituto Clinico Oncologico del Sur (ICOS)

    Temuco

Other trials in Chile

France5 sites

  • ICO - Site Paul Papin - service d'oncologie medicale

    Angers

  • Centre Georges François Leclerc - Oncologie Médicale

    Dijon

  • CHU Lille - Hôpital Claude Huriez

    Lille

  • ICO - Site René Gauducheau

    Saint-Herblain

  • CHU de Toulouse - Hôpital Ranguei

    Toulouse

Other trials in France

Germany5 sites

  • Vivantes Klinikum Neukoelln - Haematologie und Onkologie

    Berlin

  • Universitaetsklinikum Bonn AoeR - Medizinische Klinik I Gastroenterologie

    Bonn

  • Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I

    Dresden

  • Klinikum der Johann Wolfgang Goethe-Universitaet

    Frankfurt

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Medizinische Klinik I - HCC Ambulanz

    Mainz

Other trials in Germany

Australia4 sites

  • Blacktown Hospital - PARENT

    Blacktown

  • Monash Health

    Clayton

  • Epworth Freemasons

    Melbourne

  • Icon Cancer Care South Brisbane

    South Brisbane

Other trials in Australia

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori Milano

    Milan

  • IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi

    Padova

  • Università Campus Bio-Medico di Roma

    Roma

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - UOC Oncologia

    Verona

Other trials in Italy

Poland4 sites

  • Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

    Gliwice

  • Pratia

    Krakow

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

    Warsaw

  • ETG Zamosc

    Zamość

Other trials in Poland

United Kingdom1 site

  • The Christie - Dept of Oncology

    Manchester

Other trials in United Kingdom

About this study

Official title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin.

Being tested
M7824, Placebo, Gemcitabine, Cisplatin
Keywords
Metastatic Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer, Ampullary cancer, M7824, Bintrafusp alfa, Transforming growth factor-beta, Programmed death-ligand 1
Medical subject headings
Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Camurati-Engelmann Syndrome

What participants receive

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

  • M7824Drug

    Participants received intravenous infusion of M7824 at a dose of 2400 milligrams (mg), once every 3 weeks (Q3W) 2 years (in case of Complete Response), otherwise until criterion pre-sepcified in protocol for discontinuation is met, in combination with intravenous infusion of Gemcitabine and Cisplatin at a dose of 1000 milligram per meter square (mg/m^2) and 25 mg/m^2 respectively on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks.

  • PlaceboDrug

    Participants received intravenous infusion of M7824 matched placebo, once every 3 weeks (Q3W) until 2 years (in case of CR), otherwise until crtiterion pre-sepcified in protocol for discontinuation is met.

  • GemcitabineDrug

    Gemcitabine was received intravenously at a dose of 1000 milligram per meter square (mg/m^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).

  • CisplatinDrug

    Cisplatin was received intravenously at a dose of 25 mg/m^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).

Study groups in NCT04066491
Study groupRoleWhat they receive
Safety Run-In Part: M7824 + Gemcitabine + CisplatinExperimentalNot described
Receives: Drug: M7824; Drug: Gemcitabine; Drug: Cisplatin
Double-blinded Part: M7824 + Gemcitabine + CisplatinExperimentalNot described
Receives: Drug: M7824; Drug: Gemcitabine; Drug: Cisplatin
Double-blinded Part: Placebo + Gemcitabine + CisplatinPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)

    A DLT is a toxicity related to the study intervention that meets the following criteria as evaluated in the open-label, safety run-in: Grade 3 or 4 Immune-related adverse event (irAE) that needs permanent discontinuation of M7824 treatment; a malignant skin lesion induced by M7824 that is local and can be resected with a negative resection margin is not a DLT; Grade 3 or 4 nonhematologic toxicity other than irAE, A life threatening hematological toxicity (unless clearly attributable to chemotherapy alone), which is hardly medically manageable, including a bleeding event resulting in urgent intervention and admission to an intensive care unit and Grade 5 toxicity.

    Measured: Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days)

  2. Double-blind Part: Overall Survival

    Overall Survival was defined as the time from study day 1 to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

    Measured: Time from study day 1 up to data cutoff (assessed up to 609 days)

Secondary outcomes (7)

  1. Safety Run-in Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs) and Treatment Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

    Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs.

    Measured: Time from first treatment up to data cutoff (assessed up to 609 days)

  2. Safety Run-in Part: Number of Participants With Grade Greater Than or Equal (>=) 3 Laboratory Abnormalities

    Laboratory investigation included hematology and biochemistry. The number of participants with Grade >=3 laboratory abnormalities were reported. Severity of grade 3 or higher TEAEs were graded using NCI-CTCAE v5.0 toxicity grades, as follows: Grade 3 = Severe; Grade 4 = Life-threatening and Grade 5 = Death.

    Measured: Time from first treatment up to data cutoff (assessed up to 609 days)

  3. Double-blind Part: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)

    Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

    Measured: Time from randomization of study drug until the first documentation of PD or death, assessed up to 609 days

  4. Double-blind Part: Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

    Percentage of participants with confirmed objective response that is at least one overall assessment of complete response (CR) or partial response (PR) reported here. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.

    Measured: Time from randomization of study drug up to data cut off (assessed up to 609 days)

  5. Double-blind Part: Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)

    DOR was defined for participants with objective response, as the time from first documentation of objective response (confirmed Complete Response [CR] or Partial Response [PR]) to the date of first documentation of progression disease (PD) or death due to any cause, whichever occurred first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC. Results were calculated based on Kaplan-Meier estimates.

    Measured: From first documented objective response to PD or death due to any cause, assessed up to 609 days

  6. Double-blind Part: Durable Response of at Least 6 Months According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator

    Durable Response was defined as the number of participants with confirmed objective response (CR or PR) according to RECIST 1.1, determined by Investigator with duration of at least 6 months. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions.

    Measured: Time from first treatment assessed up to 1148 days

  7. Double-blind Part: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), Treatment Related TEAEs and Adverse Events of Special Interest (AESIs) According to NCI-CTCAE Version 5.0

    AE was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on treatment period. TEAEs included serious TEAEs and non-serious TEAEs. Adverse events of special interest (AESI) are serious or non-serious AEs that are of clinical interest and should be closely followed. For this study, AESIs include the following: Infusion-related reactions including immediate hypersensitivity; Immune-related AEs; Transforming growth factor beta (TGFβ) inhibition mediated skin reactions; Anemia; Bleeding AEs.

    Measured: Time from first treatment up to data cutoff (assessed up to 609 days)

Timeline

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

  1. First posted26 Aug 2019
  2. Study start20 Sep 2019
  3. Primary completion20 May 2021
  4. Study completion10 Nov 2022

Why it stopped: Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066491
Sponsor's protocol ID
MS200647_0055
Other IDs
2019-001992-35, 2019
Status last verified
Oct 2023
First submitted
22 Aug 2019
Last updated
14 Nov 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

  • Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1):e000564. doi: 10.1136/jitc-2020-000564.

    PubMed 32461347

  • Oh DY, Ikeda M, Lee CK, Rojas C, Hsu CH, Kim JW, Shen L, Furuse J, Park JO, Borad M, de Braud F, Bridgewater J, Lee SS, Moehler M, Audhuy F, Osada M, Sato M, Yoo C. Bintrafusp alfa and chemotherapy as first-line treatment in biliary tract cancer: A randomized phase 2/3 trial. Hepatology. 2025 Mar 1;81(3):823-836. doi: 10.1097/HEP.0000000000000965. Epub 2024 Jun 14.

    PubMed 38875119

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing M7824, Gemcitabine and Cisplatin in people with Biliary Tract Cancer and Cholangiocarcinoma, run by EMD Serono Research & Development Institute, Inc. at 99 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 8 inclusion and 10 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, China, Japan, Spain, South Korea 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Jun 2022). 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?

Safety Run-in Part: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) (time frame: Day 1 up to Day 21 of Cycle 1 (each Cycle is of 21 days)). 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 NCT04066491, 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 14 Nov 2023.

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