A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Choice in Participants With Relapsed/Refractory Follicular Lymphoma Who Have Received at Least 1 Prior Line of Systemic Therapy (GOLSEEK-4)
NCT ID: NCT06911502
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-07-28
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Golcadomide + Rituximab
Golcadomide
Specified dose on specified days
Rituximab
Specified dose on specified days
Rituximab + Lenalidomide/Chemotherapy
Rituximab + Lenalidomide or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone) or Rituximab + Bendamustine
Rituximab
Specified dose on specified days
Lenalidomide
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Doxorubicin
Specified dose on specified days
Vincristine
Specified dose on specified days
Prednisone/Prednisolone
Specified dose on specified days
Bendamustine
Specified dose on specified days
Interventions
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Golcadomide
Specified dose on specified days
Rituximab
Specified dose on specified days
Lenalidomide
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Doxorubicin
Specified dose on specified days
Vincristine
Specified dose on specified days
Prednisone/Prednisolone
Specified dose on specified days
Bendamustine
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed or refractory disease:
1. Relapsed FL is defined as relapse after an initial response of CR or PR to the most recent prior therapy.
2. Refractory FL is defined as best response of SD or PD or a response that lasted less than 6 months to the most recent prior therapy.
* Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
* Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
* Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
* Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.
* Lab parameters:
1. Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 (1.0 x 109 /L),
2. PLT count ≥ 75,000 cells/mm3 (75 x 109 /L)
3. Hb ≥ 7.5 g/dL
* estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
* Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≤ 2.5 x upper limit of normal (ULN). In case of documented liver involvement by lymphoma, ALT/SGPT and AST/SGOT must be ≤ 5.0× ULN.
* Serum total bilirubin ≤ 1.5 × ULN (corresponding to mild dysfunction as per National Cancer Institute Organ Dysfunction Working Group \[NCI ODWG\] criteria). In case of documented liver involvement by lymphoma, serum total bilirubin must be ≤ 3.0 × ULN (corresponding to moderate dysfunction as per NCI ODWG criteria). For cases of Gilberts syndrome, serum total bilirubin≤ 5.0 × ULN
* Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA)
Exclusion Criteria
* Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
* Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
* Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
* Presence or history of central nervous system (CNS) involvement by lymphoma.
* History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
* Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
* Participants with a history of progressive multifocal leukoencephalopathy.
* Participant has any other subtype of lymphoma.
* Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
* History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0225
Birmingham, Alabama, United States
Infirmary Cancer Care
Mobile, Alabama, United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Local Institution - 0215
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Local Institution - 0008
Jacksonville, Florida, United States
Local Institution - 0214
Tampa, Florida, United States
Local Institution - 0217
Tampa, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
Southeastern Regional Medical Center
Newnan, Georgia, United States
Local Institution - 0240
Arlington Heights, Illinois, United States
Local Institution - 0253
Iowa City, Iowa, United States
Local Institution - 0243
Waukee, Iowa, United States
Local Institution - 0216
Westwood, Kansas, United States
Local Institution - 0218
Lexington, Kentucky, United States
Local Institution - 0023
Baltimore, Maryland, United States
Greater Baltimore Medical Center
Towson, Maryland, United States
Local Institution - 0145
Boston, Massachusetts, United States
Local Institution - 0244
Boston, Massachusetts, United States
Local Institution - 0247
Boston, Massachusetts, United States
Hattiesburg Clinic Hematology/Oncology
Hattiesburg, Mississippi, United States
Local Institution - 0144
Providence, Rhode Island, United States
Texas Oncology - Central/South Texas
Austin, Texas, United States
Local Institution - 0212
Fort Worth, Texas, United States
Local Institution - 0230
San Antonio, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Local Institution - 0238
Fairfax, Virginia, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Local Institution - 0143
Vancouver, Washington, United States
Westmead Hospital
Westmead, New South Wales, Australia
Local Institution - 0132
Adelaide, South Australia, Australia
Local Institution - 0131
Hobart, Tasmania, Australia
Local Institution - 0128
Heidelberg, Victoria, Australia
Cabrini Hospital - Malvern
Malvern, Victoria, Australia
Local Institution - 0127
Perth, Western Australia, Australia
Local Institution - 0224
Perth, Western Australia, Australia
Local Institution - 0159
Vitória, Espírito Santo, Brazil
Local Institution - 0088
Niterói, Rio de Janeiro, Brazil
Local Institution - 0087
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0079
São Paulo, São Paulo, Brazil
Local Institution - 0089
Rio de Janeiro, , Brazil
Local Institution - 0066
São Paulo, , Brazil
Local Institution - 0092
São Paulo, , Brazil
Local Institution - 0200
Victoria, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Local Institution - 0250
Québec, Quebec, Canada
Local Institution - 0192
Sherbrooke, Quebec, Canada
Local Institution - 0226
Sherbrooke, Quebec, Canada
Local Institution - 0154
Santiago, Santiago Metropolitan, Chile
Local Institution - 0155
Santiago, Santiago Metropolitan, Chile
Local Institution - 0153
Santiago, Santiago Metropolitan, Chile
Local Institution - 0246
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Local Institution - 0172
Fuzhou Fujian, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Local Institution - 0241
Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Local Institution - 0175
Changsha, Hunan, China
Inner Mongolia Cancer Hospital
Hohhot, Inner Mongolia, China
Local Institution - 0233
Suzhou, Jiangsu, China
Local Institution - 0178
Nanchang, Jiangxi, China
Local Institution - 0239
Changchun, Jilin, China
Local Institution - 0177
Changchun, Jilin, China
Local Institution - 0179
Shenyang, Liaoning, China
Local Institution - 0242
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Local Institution - 0181
Shanghai, Shanghai Municipality, China
Local Institution - 0249
Shanghai, Shanghai Municipality, China
Local Institution - 0234
Sichuan, Sichuan, China
Local Institution - 0182
Tianjin, Tianjin Municipality, China
Tianjin People' s Hospital
Tianjin, Tianjin Municipality, China
Local Institution - 0248
Kunming, Yunnan, China
Local Institution - 0184
Hangzhou, Zhejiang, China
Local Institution - 0174
Zhengzhou, , China
Local Institution - 0151
Oulu, North Ostrobothnia, Finland
Local Institution - 0152
Turku, Southwest Finland, Finland
Local Institution - 0150
Helsinki, , Finland
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, France
Local Institution - 0044
Saint-Cloud, Hauts-de-Seine, France
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Loire-Atlantique, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Local Institution - 0042
Pierre-Bénite, Rhône, France
Local Institution - 0191
Paris, , France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, , France
Local Institution - 0163
Ulm, Baden-Wurttemberg, Germany
Klinikum Augsburg
Augsburg, Bavaria, Germany
Local Institution - 0220
Göttingen, Lower Saxony, Germany
GEFOS Gesellschaft f. onkologische Studien
Dortmund, North Rhine-Westphalia, Germany
Local Institution - 0193
Düsseldorf, North Rhine-Westphalia, Germany
Local Institution - 0231
Münster, North Rhine-Westphalia, Germany
Local Institution - 0232
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany
HELIOS Klinikum Erfurt
Erfurt, Thuringia, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Klinikum Chemnitz Ggmbh
Chemnitz, , Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, , Germany
Local Institution - 0162
München, , Germany
Local Institution - 0221
Würzburg, , Germany
Local Institution - 0111
Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece
Evangelismos General Hospital of Athens
Athens, Attikí, Greece
General Hospital of Athens "Laiko"
Αthens, Attikí, Greece
Local Institution - 0110
Thessaloniki, Thessaloníki, Greece
Local Institution - 0197
Thessaloniki, Thessaloníki, Greece
Local Institution - 0108
Ioannina, Ípeiros, Greece
Local Institution - 0139
Bengaluru, Karnataka, India
Local Institution - 0141
Mumbai, Maharashtra, India
Local Institution - 0142
New Delhi, National Capital Territory of Delhi, India
Local Institution - 0140
Hyderabad, Telangana, India
Local Institution - 0138
Hyderabad, Telangana, India
Local Institution - 0104
Bologna, Emilia-Romagna, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Local Institution - 0102
Alessandria, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Local Institution - 0157
Torino, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Japanease Red Cross Society Himeji Hospital
Himeji, Hyōgo, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashiku, Tokyo, Japan
University of Yamanashi Hospital
Chūō, Yamanashi, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, , Japan
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, Netherlands
Local Institution - 0046
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
AIDPORT Sp. z o.o.
Skórzewo, Greater Poland Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0190
Gdynia, Pomeranian Voivodeship, Poland
Local Institution - 0189
Lodz, Łódź Voivodeship, Poland
Local Institution - 0099
Dammam, Eastern Province, Saudi Arabia
Local Institution - 0054
Riyadh, , Saudi Arabia
Local Institution - 0052
Riyadh, , Saudi Arabia
Local Institution - 0059
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0060
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0061
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0058
Seoul, , South Korea
Hospital Universitari Parc Tauli
Sabadell, Barcelona [Barcelona], Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, Comunidad de, Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Virgen Nieves
Granada, , Spain
Local Institution - 0123
Madrid, , Spain
Local Institution - 0195
Istanbul- Fatih, Istanbul, Turkey (Türkiye)
Local Institution - 0194
Ankara, , Turkey (Türkiye)
Local Institution - 0196
Antalya, , Turkey (Türkiye)
Local Institution - 0223
Mersin, , Turkey (Türkiye)
Local Institution - 0251
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Local Institution - 0252
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Norfolk and Norwich University Hospitals NHS Foundation Trust
Cringleford, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Local Institution - 0213
London, London, City of, United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site 0225
Role: primary
Furhan Yunus, Site 0014
Role: primary
Steven Liu, Site 0074
Role: primary
Site 0215
Role: primary
Alex Herrera, Site 0072
Role: primary
Charalambos Andreadis, Site 0119
Role: primary
Site 0008
Role: primary
Site 0214
Role: primary
Site 0217
Role: primary
Dean Kirkel, Site 0021
Role: primary
Sabarish Ayyappan, Site 0245
Role: primary
Site 0240
Role: primary
Site 0253
Role: primary
Site 0243
Role: primary
Site 0216
Role: primary
Site 0218
Role: primary
Site 0023
Role: primary
Zhuoyan Li, Site 0010
Role: primary
Site 0145
Role: primary
Site 0244
Role: primary
Site 0247
Role: primary
John Hrom, Site 0013
Role: primary
Site 0144
Role: primary
Jason Melear, Site 0237
Role: primary
Site 0212
Role: primary
Site 0230
Role: primary
Habte Yimer, Site 0236
Role: primary
Site 0238
Role: primary
Christopher Vaughn, Site 0030
Role: primary
Amanda Gillespie-Twardy, Site 0146
Role: primary
Site 0143
Role: primary
Amanda Johnston, Site 0134
Role: primary
Site 0132
Role: primary
Site 0131
Role: primary
Site 0128
Role: primary
Adrian Minson, Site 0198
Role: primary
Site 0127
Role: primary
Site 0159
Role: primary
Site 0088
Role: primary
Site 0087
Role: primary
Site 0079
Role: primary
Site 0089
Role: primary
Site 0066
Role: primary
Site 0092
Role: primary
Site 0200
Role: primary
Robert Kridel, Site 0035
Role: primary
Site 0250
Role: primary
Site 0192
Role: primary
Site 0154
Role: primary
Site 0155
Role: primary
Site 0153
Role: primary
Site 0246
Role: primary
Yuqin Song, Site 0171
Role: primary
Site 0172
Role: primary
Zhiming Li, Site 0173
Role: primary
Site 0241
Role: primary
Liling Zhang, Site 0176
Role: primary
Site 0175
Role: primary
Ping Lingyan, Site 0235
Role: primary
Site 0233
Role: primary
Site 0178
Role: primary
Site 0239
Role: primary
Site 0177
Role: primary
Site 0179
Role: primary
Site 0242
Role: primary
Zengjun Li, Site 0180
Role: primary
Site 0181
Role: primary
Site 0249
Role: primary
Site 0234
Role: primary
Site 0182
Role: primary
Xingli Zhao, Site 0227
Role: primary
Site 0248
Role: primary
Site 0184
Role: primary
Site 0174
Role: primary
Site 0151
Role: primary
Site 0152
Role: primary
Site 0150
Role: primary
Francois-Xavier Gros, Site 0100
Role: primary
Site 0044
Role: primary
Guillaume Cartron, Site 0047
Role: primary
Thomas Gastinne, Site 0120
Role: primary
Franck Morschhauser, Site 0048
Role: primary
Site 0042
Role: primary
Site 0191
Role: primary
Loïc Ysebaert, Site 0121
Role: primary
Site 0163
Role: primary
Rainer Claus, Site 0161
Role: primary
Site 0220
Role: primary
Sandra Ketzler-Henkel, Site 0166
Role: primary
Site 0193
Role: primary
Site 0232
Role: primary
Konstantinos Christofyllakis, Site 0164
Role: primary
Sebastian Scholl, Site 0222
Role: primary
Ulf Schnetzke, Site 0167
Role: primary
Mathias Haenel, Site 0165
Role: primary
Thomas Illmer, Site 0187
Role: primary
Site 0162
Role: primary
Site 0221
Role: primary
Site 0111
Role: primary
Maria Bouzani, Site 0109
Role: primary
Theodoros Vassilakopoulos, Site 0107
Role: primary
Site 0110
Role: primary
Site 0197
Role: primary
Site 0108
Role: primary
Site 0139
Role: primary
Site 0141
Role: primary
Site 0142
Role: primary
Site 0140
Role: primary
Site 0138
Role: primary
Site 0104
Role: primary
Gerardo Musuraca, Site 0101
Role: primary
Armando Santoro, Site 0103
Role: primary
Sara Galimberti, Site 0106
Role: primary
Site 0102
Role: primary
Antonio Pinto, Site 0105
Role: primary
Site 0157
Role: primary
Kazuyuki Shimada, Site 0205
Role: primary
Koh Izumiyama, Site 0202
Role: primary
Takeru Asano, Site 0211
Role: primary
Kazunori Murai, Site 0201
Role: primary
Suguru Fukuhara, Site 0229
Role: primary
Katsuhiro Miura, Site 0207
Role: primary
Ichiro Kawashima, Site 0210
Role: primary
Ken Takase, Site 0209
Role: primary
Kohta Miyawaki, Site 0208
Role: primary
Tsuyoshi Muta, Site 0204
Role: primary
Sanne Tonino, Site 0050
Role: primary
Site 0046
Role: primary
Margot Jak, Site 0053
Role: primary
Michal Kwiatek, Site 0185
Role: primary
Wojciech Jurczak, Site 0186
Role: primary
Ewa Paszkiewicz-Kozik, Site 0188
Role: primary
Site 0190
Role: primary
Site 0189
Role: primary
Site 0099
Role: primary
Site 0054
Role: primary
Site 0052
Role: primary
Site 0059
Role: primary
Site 0060
Role: primary
Site 0061
Role: primary
Site 0058
Role: primary
Xavier Vilaseca Creus, Site 0158
Role: primary
Sonia Gonzalez de Villambrosia, Site 0122
Role: primary
Jose Angel Hernandez Rivas, Site 0124
Role: primary
Blanca Ferrer Lores, Site 0125
Role: primary
Jose Puerta Puerta, Site 0126
Role: primary
Site 0123
Role: primary
Site 0195
Role: primary
Site 0194
Role: primary
Site 0196
Role: primary
Site 0223
Role: primary
Site 0251
Role: primary
Site 0252
Role: primary
Joel Cunningham, Site 0148
Role: primary
Moya Young, Site 0147
Role: primary
Site 0213
Role: primary
Kim Linton, Site 0149
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-519152-82
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1314-3909
Identifier Type: OTHER
Identifier Source: secondary_id
CA073-1003
Identifier Type: -
Identifier Source: org_study_id
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