A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

NCT03498521 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: MX397952017-003040-20
• Study Type: interventional
• Target: 529
• Locations: 31 countries
• Sites: 112

Brief Summary

This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

Conditions

Cancer of Unknown Primary Site

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)

  This efficacy objective was to evaluate the efficacy of MGT vs platinum chemotherapy in term of PFS in participants with CUP whose best response to 3 cycles of platinum induction chemotherapy was assessed CR, PR, or SD.

  From randomization to the first occurrence of disease progression or death from any cause, until 330 PFS events were observed (approx. 4.3 years for MGT Cat 1 and 3.4 years for Chemotherapy Cat 1).

Secondary Outcomes (4)

• Overall Survival (OS)

  From randomization to death from any cause (approx. 4 years)

• Objective Response Rate (ORR)

  Two consecutive occurrences of complete or partial response >/=4 weeks apart (up to approximately 4 months)

• Duration of Response (DOR)

  From the first documentation of a complete response (CR) or partial response (PR) to disease progression or death from any cause, whichever occurs first (up to approximately 4 years)

• Disease Control Rate (DCR)

  From randomization to death from any cause, through the end of study (approximately 4 years)

Study Arms (2)

Molecularly-Guided Therapy

EXPERIMENTAL

Participants will be assigned to molecularly-guided therapy based on genomic profile.

Drug: Alectinib; Drug: Vismodegib; Drug: Ipatasertib; Drug: Olaparib; Drug: Erlotinib; Drug: Bevacizumab; Drug: Vemurafenib; Drug: Cobimetinib; Drug: Trastuzumab Subcutaneous (SC); Drug: Pertuzumab; Drug: Atezolizumab; Drug: Paclitaxel; Drug: Entrectinib; Drug: Ivosidenib; Drug: Pemigatinib

Platinum-Based Chemotherapy

ACTIVE COMPARATOR

Participants will receive platinum-based chemotherapy (Carboplatin or Cisplatin in combination with Gemcitabine or Paclitaxel).

Drug: Trastuzumab Subcutaneous (SC); Drug: Pertuzumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Alectinib DRUG

Alectinib will be administered orally at the label-recommended dose (600 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Vismodegib DRUG

Vismodegib will be administered orally at the label-recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Ipatasertib DRUG

Ipatasertib will be administered orally at the label-recommended dose (400 mg) once daily on Days 1-21 of each 28-day Cycle in combination with paclitaxel, and as monotherapy after the final administration of paclitaxel, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Olaparib DRUG

Olaparib will be administered orally at the label-recommended dose (400 mg) twice daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Erlotinib DRUG

Erlotinib will be administered orally in combination with Bevacizumab at the label recommended dose (150 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy

Bevacizumab DRUG

Bevacizumab will be administered intravenously at 15mg/kg every 3 weeks in combination with Erlotinib until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy

Vemurafenib DRUG

Vemurafenib will be administered orally, 960 mg twice daily, in combination with Cobimetinib, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy

Cobimetinib DRUG

Cobimetinib will be administered orally, 60mg once daily, in combination with Vemurafenib, on Days 1-21 of each 28-day Cycle, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy

Trastuzumab Subcutaneous (SC) DRUG

Trastuzumab will be administered subcutaneously, 600 mg every 3 weeks, in combination with Pertuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy; Platinum-Based Chemotherapy

Pertuzumab DRUG

Pertuzumab will be initially be administered intravenously, 840 mg, followed by 420 mg every 3 weeks, in combination with Trastuzumab and chemotherapy, until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months)

Molecularly-Guided Therapy; Platinum-Based Chemotherapy

Atezolizumab DRUG

Atezolizumab will be administered intravenously at the label-recommended dose (1200 mg), alone or in combination with chemotherapy, every 3 weeks until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Carboplatin DRUG

Carboplatin will be administered intravenously at the area under the curve (AUC) dose once every 3 weeks for up to 9 Cycles (Cycle = 21 days) in some combination with the following: Paclitaxel, Gemcitabine, Atezolizumab, Pertuzumab, and Trastuzumab SC.

Platinum-Based Chemotherapy

Paclitaxel DRUG

Paclitaxel will be administered intravenously, 175 mg/m\^2, once every 3 weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Carboplatin, Ipatasertib, Atezolizumab, Pertuzumab, and Trastuzumab SC

Molecularly-Guided Therapy; Platinum-Based Chemotherapy

Cisplatin DRUG

Cisplatin will be administered intravenously, 60-75 mg/m\^2, once every three weeks, for up to 9 cycles (Cycle = 21 days) in some combination with the following: Gemcitabine, Paclitaxel, Atezolizumab, Pertuzumab, and Trastuzumab SC.

Platinum-Based Chemotherapy

Gemcitabine DRUG

Gemcitabine will be administered intravenously, 1000 mg/m\^2, twice every three weeks for up to 9 cycles (Cycle = 21 days) in some combination with the following: Cisplatin, Carboplatin, Atezolizumab, Pertuzumab, and Trastuzumab SC.

Platinum-Based Chemotherapy

Entrectinib DRUG

Entrectinib will be administered orally at the label-recommended dose (600 mg) once daily until loss of clinical benefit or unacceptable toxicity, through the end of the study (approximately 70 months).

Molecularly-Guided Therapy

Ivosidenib DRUG

Ivosidenib will be administered orally at the label-recommended dose (500mg) once daily across a 28-day treatment cycle until loss of clinical benefit or unacceptable toxicity.

Molecularly-Guided Therapy

Pemigatinib DRUG

Pemigatinib will be administered orally at the label-recommended dose (13.5mg) once daily across a 21-day treatment cycle until loss of clinical benefit or unacceptable toxicity.

Molecularly-Guided Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed unresectable cancer of unknown primary site (CUP) diagnosed according to criteria defined in the 2015 European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for CUP
• No prior lines of systemic therapy for the treatment of CUP
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Candidate for platinum-based chemotherapy (according to the reference information for the intended chemotherapy)
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• Formalin-Fixed Paraffin-Embedded (FFPE) tumor tissue sample \</= 4 months old that is expected to be sufficient for generation of a comprehensive genomic profile at a central reference pathology laboratory

You may not qualify if:

• Squamous cell CUP
• Participants who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor (favorable prognosis CUP subsets): Poorly differentiated carcinoma with midline distribution; women with papillary adenocarcinoma of the peritoneal cavity; women with adenocarcinoma involving only the axillary lymph nodes; squamous cell carcinoma of the cervical lymph nodes; poorly differentiated neuroendocrine tumors; men with blastic bone metastases and elevated prostate-specific antigen (PSA); participants with a single, small, potentially resectable tumor; colon cancer-type CUP, including participants with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile; CK7-positive, CK20-negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer; IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast; high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity; IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF; IHC profile compatible with cholangiocarcinoma or pancreatobiliary (or upper gastrointestinal carcinoma) AND 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver
• Known presence of brain or spinal cord metastasis (including metastases that have been irradiated only)
• Histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma/adenocarcinoma
• History or known presence of leptomeningeal disease
• Known human immunodeficiency virus (HIV) infection
• Significant cardiovascular disease
• Prior allogeneic stem cell or solid organ transplantation
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or for up to 7 months after the final dose of treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Foundation Medicine: collaborator

Study Sites (125)

Blacktown Hospital

Blacktown, New South Wales, NSW 2148, Australia

Location

GenesisCare North Shore

St Leonards, New South Wales, 2065, Australia

Location

Icon Cancer Foundation

South Brisbane, Queensland, 4101, Australia

Location

Lkh-Univ. Klinikum Graz

Graz, 8036, Austria

Location

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, 5020, Austria

Location

Medizinische Universität Wien

Vienna, 1090, Austria

Location

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Instituto Nacional de Cancer - INCa

Rio de Janeiro, 20560-120, Brazil

Location

MHAT Nadezhda

Sofia, 1330, Bulgaria

Location

MBAL Serdika EOOD

Sofia, 1632, Bulgaria

Location

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

Location

James Lind Centro de Investigación Del Cáncer

Temuco, 4800827, Chile

Location

Clinica del Country

Bogotá, 11001, Colombia

Location

Inst. Nacional de Cancerologia

Bogotá, Colombia

Location

Oncomedica S.A.

Montería, 230002, Colombia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, 128 08, Czechia

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

North Estonia Medical Centre, Oncology and hematology Clinic

Tallinn, 13419, Estonia

Location

Helsinki University Central Hospital

Helsinki, 00250, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Ico - Paul Papin

Angers, 49000, France

Location

CHRU Besançon

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CRLCC-Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

Clermont-Ferrand, 63003, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Institut régional du Cancer Montpellier

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Institut Curie

Paris, 75231, France

Location

CHU Lyon - Centre Hospitalier Lyon Sud

Pierre-Benite (Lyon), 69495, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHU Strasbourg Hpital Hautepierre

Strasbourg, 67098, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

Location

Charité-Universitätsm. Berlin

Berlin, 13353, Germany

Location

Onkologisches Zentrum - Onkologie Dachau

Dachau, 85221, Germany

Location

Universitätsklinikum Frankfurt, UCT

Frankfurt, 60590, Germany

Location

SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III

Heilbronn, 74078, Germany

Location

Universitätsklinikum Jena, Klinik für Innere Medizin II

Jena, 07740, Germany

Location

Klinikum Mannheim III. Medizinische Klinik

Mannheim, 68167, Germany

Location

Klinikum der LMU München, Campus Großhadern, Krebszentrum München

München, 81377, Germany

Location

Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie

Münster, 48149, Germany

Location

RED-Oncology GmbH

Oldenburg / Holstein, 23758, Germany

Location

Anticancer Hospital Ag Savas

Athens, 115 22, Greece

Location

IASO General Hospital of Athens

Athens, 155 62, Greece

Location

Univ General Hosp Heraklion

Heraklion, 711 10, Greece

Location

Uni Hospital of Ioannina

Ioannina, 455 00, Greece

Location

Theagenio Anticancer Hospital

Thessaloniki, 540 07, Greece

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Budapesti Uzsoki Utcai Kórház

Budapest, 1145, Hungary

Location

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000, Hungary

Location

St Vincent'S Uni Hospital

Dublin, D04 T6F4, Ireland

Location

Waterford Regional Hospital

Waterford, X91 ER8E, Ireland

Location

Rabin MC

Petah Tikva, 4941492, Israel

Location

Chaim Sheba medical center, Oncology division

Ramat Gan, 5262000, Israel

Location

Tel Aviv Sourasky Medical Ctr

Tel Aviv, 6423906, Israel

Location

U. O. Oncologia Medica, Ospedale Santa Chiara

Pisa, Basilicate, 56100, Italy

Location

Policlinico Univ. - A.O. Mater Domini

Catanzaro, Calabria, 88100, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Campania, 80131, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Asst Papa Giovanni XXIII

Bergamo, Lombardy, 24128, Italy

Location

Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

Milan, Lombardy, 20162, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV)

Padua, Veneto, 35128, Italy

Location

Aichi Cancer Center

Aichi, 464-8681, Japan

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Riga East Clinical University Hospital Latvian Oncology Centre

Riga, LV-1079, Latvia

Location

Health Pharma Professional Research

CD Mexico, Mexico CITY (federal District), 03810, Mexico

Location

AVIX Investigación Clínica S.C

Monterrey, Nuevo León, 64710, Mexico

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Ziekenhuis VieCuri Medisch Centrum

Venlo, 5912 BL, Netherlands

Location

Sørlandet Sykehus Kristiansand

Kristiansand, 4604, Norway

Location

Akershus universitetssykehus HF

Lørenskog, 1478, Norway

Location

Oslo universitetssykehus HF, Ullevål, Kreftsenteret

Oslo, 0450, Norway

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, 15038, Peru

Location

Oncosalud Sac

Lima, 41, Peru

Location

Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Location

IPO do Porto

Porto, 4200-072, Portugal

Location

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, 400015, Romania

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

Oncocenter Timisoara

Timi?oara, 300166, Romania

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Hospital Sant Joan Despi- Moises Broggi

Sant Joan Despí, Barcelona, 08970, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Clínic i Provincial

Barcelona, 08036, Spain

Location

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Universitaetsspital Basel

Basel, 4031, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

Ramathibodi Hospital;Medicine/Oncology

Bangkok, 10400, Thailand

Location

Faculty of Med. Siriraj Hosp.

Bangkok, 10700, Thailand

Location

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Oncology Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, 07070, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, 22030, Turkey (Türkiye)

Location

Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

?zmir Medical Point

Kar?iyaka, 35575, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital

S?hhiye, Ankara, 06100, Turkey (Türkiye)

Location

Royal United Hospital

Bath, BA1 3NG, United Kingdom

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Torbay Hospital

Torquay, TQ27AA, United Kingdom

Location

Related Publications (1)

• Kramer A, Bochtler T, Pauli C, Shiu KK, Cook N, de Menezes JJ, Pazo-Cid RA, Losa F, Robbrecht DG, Tomasek J, Arslan C, Ozguroglu M, Stahl M, Bigot F, Kim SY, Naito Y, Italiano A, Chalabi N, Duran-Pacheco G, Michaud C, Scarato J, Thomas M, Ross JS, Moch H, Mileshkin L. Molecularly guided therapy versus chemotherapy after disease control in unfavourable cancer of unknown primary (CUPISCO): an open-label, randomised, phase 2 study. Lancet. 2024 Aug 10;404(10452):527-539. doi: 10.1016/S0140-6736(24)00814-6. Epub 2024 Jul 31.

  PMID: 39096924 DERIVED

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

alectinib; HhAntag691; ipatasertib; olaparib; Erlotinib Hydrochloride; Bevacizumab; Vemurafenib; cobimetinib; pertuzumab; atezolizumab; Carboplatin; Paclitaxel; Cisplatin; Gemcitabine; entrectinib; ivosidenib; pemigatinib

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 13, 2018
• Study Start: July 10, 2018
• Primary Completion: February 14, 2023
• Study Completion: November 7, 2024
• Last Updated: November 19, 2025
• Results First Posted: June 14, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

ME (2); CZ (3); IT (7); IL (3); FI (2); PE (2); RO (4); TH (2); AU (3); LA (1); BR (5); DE (10); IE (2); PL (1); GB (8); NO (3); DK (1); HU (3); GR (5); CL (2); PT (1); FR (15); JP (3); BU (2); CO (3); KR (4); CR (1); TU (8); CH (2); ES (1); NL (3)