A Randomized, Phase 2/3 Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Bristol-Myers Squibb (industry)

Phase: 2/3

Start date: July 21, 2025

Planned enrollment: 470

Trial ID: NCT07076121
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: BMS-986504 (MRTX1719)

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Goal: Evaluate whether adding BMS-986504, a selective MTA-cooperative PRMT5 inhibitor, to standard first-line nab-paclitaxel/gemcitabine improves outcomes versus placebo plus nab-paclitaxel/gemcitabine in untreated metastatic PDAC with homozygous MTAP deletion or demonstrable MTAP loss.

Patients: Adults with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma harboring homozygous MTAP deletion or MTAP loss, with at least one measurable lesion by RECIST v1.1, and no prior systemic therapy for metastatic disease. One induction cycle of nab-paclitaxel/gemcitabine before randomization is allowed if no progression or intolerable toxicity occurred. Key exclusions include active concurrent malignancy requiring treatment within 2 years and other protocol-defined criteria.

Design: Randomized, placebo-controlled, multi-arm Phase 2/3 study with parallel assignment comparing BMS-986504 plus nab-paclitaxel/gemcitabine versus placebo plus nab-paclitaxel/gemcitabine. Approximately 470 participants will be enrolled, with efficacy assessed per RECIST v1.1 and time-to-event endpoints followed up to three years post last randomization.

Treatments: Experimental arms receive BMS-986504 in combination with nab-paclitaxel and gemcitabine; control arms receive placebo with nab-paclitaxel and gemcitabine. BMS-986504 (formerly MRTX1719) is an investigational, selective MTA-cooperative PRMT5 inhibitor that targets the PRMT5–MTA complex, exploiting synthetic lethality in MTAP-deleted tumors by disrupting essential arginine methylation. In a prior Phase 1/2 study across MTAP-deleted solid tumors, BMS-986504 showed an objective response rate of about 23% in heavily pretreated patients and was generally well tolerated. Nab-paclitaxel plus gemcitabine is a standard first-line regimen in metastatic PDAC.

Outcomes: Co-primary endpoints are progression-free survival by RECIST v1.1 and overall survival. Key secondary endpoints include objective response rate, duration of response, time to objective response, disease control rate, and a secondary analysis of PFS by RECIST v1.1. Assessments are planned for up to three years after the last participant is randomized.

Burden on patient: Moderate. The backbone chemotherapy and imaging schedule will resemble standard first-line PDAC care with RECIST-based scans at regular intervals, but participation adds required screening for MTAP status and protocolized assessments. As an oral targeted agent, BMS-986504 is unlikely to add infusion time beyond chemotherapy; however, investigational therapy typically entails more frequent clinic visits early in treatment, additional laboratory monitoring for safety, and potential on-study tumor tissue confirmation. No intensive pharmacokinetic sampling typical of Phase 1 is expected, but Phase 2/3 safety labs and imaging may increase visit frequency compared with routine practice. Travel burden aligns with chemotherapy infusion schedules, with added visits for study-specific evaluations.

Last updated: Nov 2025

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Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)

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Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

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Dublin, D04 T6F4, Ireland

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Naples, 80131, Italy

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Ospedale San Raffaele

Milan, 20132, Italy

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Milan, Lombardy, 20133, Italy

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Rozzano, Milano, 20089, Italy

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Pisa, Tuscany, 56126, Italy

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Padova, Veneto, 35128, Italy

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National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

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Chuo-ku, Tokyo, 104-0045, Japan

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Warsaw, Masovian Voivodeship, 02-172, Poland

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Fundeni Clinical Institute

Bucharest, 022328, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 700483, Romania

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Bucharest, 030171, Romania

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Ploieşti, 100337, Romania

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Cluj-Napoca, Cluj, 400162, Romania

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SC Radiotherapy Center Cluj SRL

Florești, Cluj, 407280, Romania

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Craiova, Dolj, 200542, Romania

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Singapore, 119074, Singapore

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Singapore, Central Singapore, 168583, Singapore

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Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

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Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

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Madrid, 28050, Spain

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Zaragoza, 50009, Spain

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Seville, 41013, Spain

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Barcelona, Barcelona [Barcelona], 08035, Spain

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Madrid, Madrid, Comunidad de, 28009, Spain

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Madrid, Madrid, Comunidad de, 28041, Spain

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Stockholm, Stockholms Län [se-01], 141 86, Sweden

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Uppsala, Uppsala Län [se-03], 751 85, Sweden

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Bern, Canton of Bern, 3010, Switzerland

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Taoyuan District, 333, Taiwan

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Taichung, 404332, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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London, SW3 6JJ, United Kingdom

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London, England, NW32QG, United Kingdom

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London, London, City of, SE1 9RT, United Kingdom

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London, London, City of, w1g 6ad, United Kingdom

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London, Sutton, SM2 5PT, United Kingdom

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Highlands Oncology Group

Springdale, Arkansas, 72762, United States

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La Jolla, California, 92037, United States

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Marietta, Georgia, 30060, United States

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Boise, Idaho, 83712, United States

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Detroit, Michigan, 48202, United States

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Mineola, New York, 11501, United States

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Mineola, New York, 11501, United States

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Lake Success, New York, 11042, United States

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Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

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Rochester, New York, 14642, United States

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Chapel Hill, North Carolina, 27514, United States

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Portland, Oregon, 97227, United States

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Bethlehem, Pennsylvania, 18015, United States

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SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

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Tennessee Oncology, PLLC

Smyrna, Tennessee, 37167, United States

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Texas Oncology - DFW

Dallas, Texas, 75246, United States

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University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

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Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

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Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

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Local Institution - 0044

ABB, Buenos Aires F.D., C1199ABB, Argentina

No email / No phone

Status: Not yet recruiting

Local Institution - 0226

Brisbane, Queensland, 4102, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0229

Woodville, South Australia, 5011, Australia

No email / No phone

Status: Not yet recruiting

Local Institution - 0211

Vienna, 1090, Austria

No email / No phone

Status: Not yet recruiting

Local Institution - 0034

Liège, 4000, Belgium

No email / No phone

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Local Institution - 0031

Bonheiden, Antwerpen, 2820, Belgium

No email / No phone

Status: Not yet recruiting

Local Institution - 0035

Edegem, Antwerpen, 2650, Belgium

No email / No phone

Status: Not yet recruiting

Local Institution - 0063

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

No email / No phone

Status: Not yet recruiting

Local Institution - 0065

Brussels, Bruxelles-Capitale, Région de, 1070, Belgium

No email / No phone

Status: Not yet recruiting

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Ghent, Oost-Vlaanderen, 9000, Belgium

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Status: Not yet recruiting

Local Institution - 0032

Leuven, Vlaams-Brabant, 3000, Belgium

No email / No phone

Status: Not yet recruiting

Local Institution - 0075

São Paulo, 01246-000, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0100

Rio de Janeiro, 22250-905, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0332

São Paulo, 01401-002, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0102

Vitória, Espírito Santo, 29055450, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0291

Salvador, Estado de Bahia, 41253-190, Brazil

No email / No phone

Status: Not yet recruiting

Local Institution - 0074

Natal, Rio Grande do Norte, 59062-000, Brazil

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Status: Not yet recruiting

Local Institution - 0200

Vancouver, British Columbia, V5Z 4E6, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0202

Halifax, Nova Scotia, B3H 2Y9, Canada

No email / No phone

Status: Not yet recruiting

Local Institution - 0046

Santiago, Santiago Metropolitan, 7620002, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0047

Santiago, Santiago Metropolitan, 8420383, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0048

Santiago, Santiago Metropolitan, 7500921, Chile

No email / No phone

Status: Not yet recruiting

Local Institution - 0312

Hefei, Anhui, 230000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0346

Beijing, Beijing Municipality, 100021, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0307

Chongqing, Chongqing Municipality, 400030, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0297

Fuzhou, Fujian, 350014, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0313

Guangzhou, Guangdong, 510120, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0352

Guangzhou, Guangdong, 510080, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0302

Harbin, Heilongjiang, 150081, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0295

Luoyang, Henan, 471003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0353

Zhengzhou, Henan, 450000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0293

Changsha, Hunan, 421000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0311

Nanjing, Jiangsu, 210009, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0354

Changzhou, Jiangsu, 213003, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0304

Shenyang, Liaoning, 110042, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0334

Jining, Shandong, 272029, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0300

Shanghai, Shanghai Municipality, 200040, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0351

Taiyuan, Shanxi, 030000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0305

Chengdu, Sichuan, 610066, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0356

Hangzhou, Zhejiang, 310000, China

No email / No phone

Status: Not yet recruiting

Local Institution - 0266

Bogotá, 110411, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0267

Medellín, Antioquia, 050030, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0338

Rionegro, Antioquia, 054047, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0269

Montería, Departamento de Córdoba, 230002, Colombia

No email / No phone

Status: Not yet recruiting

Local Institution - 0130

Prague, 12808, Czechia

No email / No phone

Status: Not yet recruiting

Local Institution - 0070

Olomouc, Olomouc Region, 779 00, Czechia

No email / No phone

Status: Not yet recruiting

Local Institution - 0119

Prague, Praha 5, 150 06, Czechia

No email / No phone

Status: Not yet recruiting

Local Institution - 0021

Aalborg, North Denmark, 9000, Denmark

No email / No phone

Status: Not yet recruiting

Local Institution - 0067

Lyon, Auvergne-Rhône-Alpes, 69003, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0029

Montpellier, Hérault, 34298, France

No email / No phone

Status: Not yet recruiting

Local Institution - 0242

München, Bavaria, 81675, Germany

No email / No phone

Status: Not yet recruiting

Local Institution - 0270

Shatin, NT, Hong Kong

No email / No phone

Status: Not yet recruiting

Local Institution - 0188

Kochi, Kerala, 682041, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0152

New Delhi, National Capital Territory of Delhi, 110029, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0179

Bhubaneswar, Odisha, 751003, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0147

Hyderabad, Telangana, 500033, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0190

Hyderabad, Telangana, 500032, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0154

Varanasi, Uttar Pradesh, 221005, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0153

Kolkata, West Bengal, 700094, India

No email / No phone

Status: Not yet recruiting

Local Institution - 0081

Petah Tikva, 4941492, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0078

Ramat Gan, Central District, 5265601, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0080

Ẕerifin, Central District, 70300, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0097

Jerusalem, Jerusalem, 9112001, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0077

Afula, Northern District, 1834111, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0076

Tel Aviv, Tell Abīb, 6423906, Israel

No email / No phone

Status: Not yet recruiting

Local Institution - 0221

Osaka, 541-8567, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0222

Nagoya, Aichi-ken, 464-8681, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0219

Sapporo, Hokkaido, 060-8543, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0218

Yokohama, Kanagawa, 2418515, Japan

No email / No phone

Status: Not yet recruiting

Local Institution - 0256

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

No email / No phone

Status: Not yet recruiting

Local Institution - 0258

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

No email / No phone

Status: Not yet recruiting

Local Institution - 0257

Kuching, Sarawak, 93586, Malaysia

No email / No phone

Status: Not yet recruiting

Local Institution - 0262

Puebla City, 72424, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0281

Querétaro, 76000, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0364

Zapopan, Jalisco, 45050, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0260

Mexico City, Mexico City, 03100, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0261

Cuauhtémoc, Ciudad de México, Mexico City, 06100, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0264

Monterrey, Nuevo León, 64460, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0265

Oaxaca City, Oaxaca, 68020, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0372

Mérida, Yucatán, 97070, Mexico

No email / No phone

Status: Not yet recruiting

Local Institution - 0038

Maastricht, Limburg, 6229 HX, Netherlands

No email / No phone

Status: Not yet recruiting

Local Institution - 0039

Breda, North Brabant, 4818 CK, Netherlands

No email / No phone

Status: Not yet recruiting

Local Institution - 0037

Rotterdam, South Holland, 3015 GD, Netherlands

No email / No phone

Status: Not yet recruiting

Local Institution - 0277

Leiden, South Holland, 2333 ZA, Netherlands

No email / No phone

Status: Not yet recruiting

Local Institution - 0379

Warsaw, 02-781, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0251

Gdask, Pomeranian Voivodeship, 80-952, Poland

No email / No phone

Status: Not yet recruiting

Local Institution - 0252

Singapore, 308433, Singapore

No email / No phone

Status: Not yet recruiting

Local Institution - 0253

Singapore, 329563, Singapore

No email / No phone

Status: Not yet recruiting

Local Institution - 0272

Banská Bystrica, 97517, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0275

Bratislava, 83101, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0273

Košice, Košice Region, 041 91, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0274

Trenčín, Trenčín Region, 911 01, Slovakia

No email / No phone

Status: Not yet recruiting

Local Institution - 0240

Soweto, Gauteng, 2013, South Africa

No email / No phone

Status: Not yet recruiting

Local Institution - 0241

Pretoria, Gauteng, 0001, South Africa

No email / No phone

Status: Not yet recruiting

Local Institution - 0246

Johannesburg, Gauteng, 2193, South Africa

No email / No phone

Status: Not yet recruiting

Local Institution - 0335

Cape Town, Western Cape, 7937, South Africa

No email / No phone

Status: Not yet recruiting

Local Institution - 0283

Adana, 01250, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0285

Istanbul, 34899, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0286

Ankara, 06230, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0287

Ankara, 06560, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0284

Stanbul, Istanbul, 34214, Turkey (Türkiye)

No email / No phone

Status: Not yet recruiting

Local Institution - 0142

Phoenix, Arizona, 85054, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0365

Tucson, Arizona, 85724, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0157

San Francisco, California, 94115, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0139

Jacksonville, Florida, 32224, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0369

Jacksonville, Florida, 32207, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0367

Atlanta, Georgia, 30322, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0168

Chicago, Illinois, 60637, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0125

Westwood, Kansas, 66205, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0370

Louisville, Kentucky, 40202, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0145

Baltimore, Maryland, 21287, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0371

Baltimore, Maryland, 21201, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0120

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0182

Rochester, Minnesota, 55905, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0140

New York, New York, 10029, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0279

New York, New York, 10065, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0376

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0162

Portland, Oregon, 97239, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0158

Philadelphia, Pennsylvania, 19107, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0289

Pittsburgh, Pennsylvania, 15232, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0301

Lancaster, Pennsylvania, 17601, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0368

Pittsburgh, Pennsylvania, 15212, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0170

Temple, Texas, 76508, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0374

Fort Worth, Texas, 76177, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0344

Salt Lake City, Utah, 84111, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0348

Norfolk, Virginia, 23502, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0169

Seattle, Washington, 98101, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0195

Milwaukee, Wisconsin, 53226, United States

No email / No phone

Status: Not yet recruiting

Local Institution - 0156

Viña del Mar, Valparaiso, 2520598, Chile

No email / No phone

Status: Withdrawn

Local Institution - 0296

Fuzhou, Fujian, 350014, China

No email / No phone

Status: Withdrawn

Local Institution - 0298

Wuhan, Hubei, 430079, China

No email / No phone

Status: Withdrawn

Local Institution - 0239

Shanghai Shi, Shanghai Municipality, 200032, China

No email / No phone

Status: Withdrawn

Local Institution - 0355

Shanghai, Shanghai Municipality, 200032, China

No email / No phone

Status: Withdrawn

Local Institution - 0362

Rionegro, Antioquia, 054047, Colombia

No email / No phone

Status: Withdrawn

Local Institution - 0268

Pereira, Risaralda Department, 660001, Colombia

No email / No phone

Status: Withdrawn

Local Institution - 0116

Aarhus, Central Jutland, 8200, Denmark

No email / No phone

Status: Withdrawn

Local Institution - 0263

Mexico City, 14210, Mexico

No email / No phone

Status: Withdrawn

Local Institution - 0132

Tampa, Florida, 33612, United States

No email / No phone

Status: Withdrawn

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