Sponsor:
Merck Sharp & Dohme LLC
Code:
NCT06393374
Conditions
Triple-Negative Breast Cancer
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Pembrolizumab
Sacituzumab tirumotecan
Capecitabine
Brief summary:
Conditions
Triple-Negative Breast Cancer
Study ID
NCT06393374
Start date
Jun 24, 2024
Status verified date
Sep, 2026
Completion date
Dec 14, 2037
Anticipated
Primary completion date
Dec 16, 2030
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
1530 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Pembrolizumab + sacituzumab tirumotecan
active comparator: Treatment of Physician's Choice
Interventions
Pembrolizumab
Sacituzumab tirumotecan
Capecitabine
Primary outcome measure
Central contacts
Locations
Infirmary Cancer Care ( Site 0001)
Recruiting
Mobile, Alabama, United States, 36607
Contacts
Study Coordinator
251-435-2273Ironwood Cancer & Research Centers-Research ( Site 0054)
Recruiting
Chandler, Arizona, United States, 85224
Contacts
Study Coordinator
480-821-2838MemorialCare Orange Coast Medical Center ( Site 9501)
Recruiting
Fountain Valley, California, United States, 92708
Contacts
Study Coordinator
714-378-7000Scripps Cancer Center ( Site 0052)
Recruiting
La Jolla, California, United States, 92037
Contacts
Study Coordinator
800-727-4777Kaiser Permanente - Oakland ( Site 0079)
Recruiting
Oakland, California, United States, 94611
Contacts
Study Coordinator
877-642-4691Profound Research LLC ( Site 0105)
Recruiting
Oceanside, California, United States, 92056
Contacts
Study Coordinator
760-826-2020Kaiser Permanente - Roseville ( Site 0081)
Recruiting
Roseville, California, United States, 95661
Contacts
Study Coordinator
877-642-4691Kaiser Permanente - San Francisco ( Site 0080)
Recruiting
San Francisco, California, United States, 94115
Contacts
Study Coordinator
877-642-4691Kaiser Permanente - Santa Clara ( Site 0082)
Recruiting
Santa Clara, California, United States, 95051
Contacts
Study Coordinator
877-642-4691Providence Medical Foundation ( Site 9543)
Recruiting
Santa Rosa, California, United States, 95403
Contacts
Study Coordinator
707-528-1050Kaiser Permanente Vallejo Medical Center ( Site 0060)
Recruiting
Vallejo, California, United States, 94589
Contacts
Study Coordinator
877-642-4691Kaiser Permanente - Walnut Creek ( Site 0078)
Recruiting
Walnut Creek, California, United States, 94596
Contacts
Study Coordinator
877-642-4691Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)
Recruiting
Grand Junction, Colorado, United States, 81501
Contacts
Study Coordinator
970-298-7500University of Connecticut Health Center ( Site 0128)
Recruiting
Farmington, Connecticut, United States, 06030
Contacts
Study Coordinator
860-679-2100Yale Cancer Center ( Site 0053)
Recruiting
New Haven, Connecticut, United States, 06510
Contacts
Study Coordinator
203-688-4242Helen F. Graham Cancer Center & Research Institute ( Site 0018)
Recruiting
Newark, Delaware, United States, 19713
Contacts
Study Coordinator
302-366-1200AdventHealth Altamonte Springs ( Site 0125)
Recruiting
Altamonte Springs, Florida, United States, 32701
Contacts
Study Coordinator
407-834-5151Orlando Health Cancer Institute ( Site 0030)
Recruiting
Orlando, Florida, United States, 32806
Contacts
Study Coordinator
321-843-8370Comprehensive Hematology Oncology ( Site 0091)
Recruiting
St. Petersburg, Florida, United States, 33709
Contacts
Study Coordinator
727-344-6569Cleveland Clinic Martin North Hospital ( Site 0114)
Recruiting
Stuart, Florida, United States, 34994
Contacts
Study Coordinator
772-419-2146Illinois Cancer Specialists (ICS) ( Site 8010)
Recruiting
Arlington Heights, Illinois, United States, 60005
Contacts
Study Coordinator
847-259-4482Orchard Healthcare Research Inc. ( Site 0014)
Recruiting
Skokie, Illinois, United States, 60077
Contacts
Study Coordinator
224-534-7580Northwest Cancer Center - Dyer Clinic ( Site 0097)
Recruiting
Dyer, Indiana, United States, 46311
Contacts
Study Coordinator
615-785-5914Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
Recruiting
Fort Wayne, Indiana, United States, 46845
Contacts
Study Coordinator
260-266-6313Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)
Recruiting
Edgewood, Kentucky, United States, 41017
Contacts
Study Coordinator
859-301-4000CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)
Recruiting
Alexandria, Louisiana, United States, 71301
Contacts
Study Coordinator
318-528-6976Louisiana State University Health Sciences Shreveport ( Site 0029)
Recruiting
Shreveport, Louisiana, United States, 71103
Contacts
Study Coordinator
318-813-1429Holy Cross Hospital ( Site 0069)
Recruiting
Silver Spring, Maryland, United States, 20910
Contacts
Study Coordinator
301-754-7552University of Michigan ( Site 0103)
Recruiting
Ann Arbor, Michigan, United States, 48109
Contacts
Study Coordinator
800-865-1125Henry Ford Health ( Site 0010)
Recruiting
Detroit, Michigan, United States, 48202
Contacts
Study Coordinator
313-598-2556Metro-Minnesota Community Clinical Oncology ( Site 0031)
Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contacts
Study Coordinator
952-993-3252University of Mississippi Medical Center ( Site 0043)
Recruiting
Jackson, Mississippi, United States, 39216
Contacts
Study Coordinator
601-984-5590Lake Regional Hospital ( Site 0009)
Recruiting
Osage Beach, Missouri, United States, 65065
Contacts
Study Coordinator
573-302-2772Siteman Cancer Center ( Site 0099)
Recruiting
St Louis, Missouri, United States, 63108
Contacts
Study Coordinator
314-362-0263Optum Care Cancer Center ( Site 9535)
Recruiting
Las Vegas, Nevada, United States, 89102
Contacts
Study Coordinator
702-724-8787Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)
Recruiting
Las Vegas, Nevada, United States, 89128
Contacts
Study Coordinator
702-609-9427New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)
Recruiting
Albuquerque, New Mexico, United States, 87109
Contacts
Study Coordinator
505-842-8171CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)
Recruiting
Santa Fe, New Mexico, United States, 87505
Contacts
Study Coordinator
505-913-8953The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)
Recruiting
New York, New York, United States, 10011
Contacts
Study Coordinator
212-604-6000Icahn School of Medicine at Mount Sinai ( Site 0123)
Recruiting
New York, New York, United States, 10029
Contacts
Study Coordinator
212-241-3300Memorial Sloan Kettering Cancer Center ( Site 0067)
Recruiting
New York, New York, United States, 10065
Contacts
Study Coordinator
212-639-2000Clinical Research Alliance ( Site 0086)
Recruiting
Westbury, New York, United States, 11590
Contacts
Study Coordinator
516-734-8906Levine Cancer Institute ( Site 0083)
Recruiting
Charlotte, North Carolina, United States, 28204
Contacts
Study Coordinator
980-442-3130Cape Fear Valley Health System ( Site 0136)
Recruiting
Fayetteville, North Carolina, United States, 28304
Contacts
Study Coordinator
472-210-8847Sanford Cancer Center Bismarck ( Site 0058)
Recruiting
Bismarck, North Dakota, United States, 58501
Contacts
Study Coordinator
701-323-5741Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)
Recruiting
Fargo, North Dakota, United States, 58102
Contacts
Study Coordinator
701-234-2000Altru Cancer Center ( Site 0104)
Recruiting
Grand Forks, North Dakota, United States, 58201
Contacts
Study Coordinator
701-780-5451Cleveland Clinic - Mercy Hospital ( Site 0057)
Recruiting
Canton, Ohio, United States, 44708
Contacts
Study Coordinator
330-489-1274Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
Recruiting
Massillon, Ohio, United States, 44646
Contacts
Study Coordinator
330-478-0001Taylor Cancer Research Center ( Site 9500)
Recruiting
Maumee, Ohio, United States, 43537
Contacts
Study Coordinator
567-402-4501Genesis Healthcare System ( Site 0025)
Recruiting
Zanesville, Ohio, United States, 43701
Contacts
Study Coordinator
740-454-5271Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
Recruiting
Tulsa, Oklahoma, United States, 74146
Contacts
Study Coordinator
918-505-3200Providence Portland Medical Center ( Site 0116)
Recruiting
Portland, Oregon, United States, 97213
Contacts
Study Coordinator
503-215-1979Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)
Recruiting
Portland, Oregon, United States, 97225
Contacts
Study Coordinator
503-215-1979Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contacts
Study Coordinator
215-955-8874Cancer Care Associates Of York ( Site 9517)
Recruiting
York, Pennsylvania, United States, 17403
Contacts
Study Coordinator
717-741-9229Sanford Cancer Center ( Site 0059)
Recruiting
Sioux Falls, South Dakota, United States, 57104
Contacts
Study Coordinator
605-328-8000West Cancer Center and Research Institute ( Site 0084)
Recruiting
Germantown, Tennessee, United States, 38138
Contacts
Study Coordinator
901-683-0055Baptist Cancer Center ( Site 0101)
Recruiting
Memphis, Tennessee, United States, 38120
Contacts
Study Coordinator
901-226-3077One Oncology - Tennessee Oncology ( Site 0098)
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Study Coordinator
615-986-4350SCRI Oncology Partners ( Site 7000)
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Study Coordinator
615-329-7274Tennessee Oncology ( Site 0111)
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Study Coordinator
615-986-4350Vanderbilt Health One Hundred Oaks ( Site 0042)
Recruiting
Nashville, Tennessee, United States, 37212
Contacts
Study Coordinator
800-811-8480Hendrick Medical Center ( Site 0117)
Recruiting
Abilene, Texas, United States, 79601
Contacts
Study Coordinator
325-670-2000Harrington Cancer Center ( Site 0061)
Recruiting
Amarillo, Texas, United States, 79106
Contacts
Study Coordinator
806-359-4673Texas Oncology - DFW ( Site 8000)
Recruiting
Dallas, Texas, United States, 75246
Contacts
Study Coordinator
214-370-1000Parkland Health & Hospital System ( Site 0096)
Recruiting
Dallas, Texas, United States, 75390
Contacts
Study Coordinator
214-645-4673University of Texas Southwestern Medical Center ( Site 0032)
Recruiting
Dallas, Texas, United States, 75390
Contacts
Study Coordinator
214-645-4673Texas Oncology - Northeast Texas ( Site 8005)
Recruiting
Flower Mound, Texas, United States, 75028
Contacts
Study Coordinator
972-537-4100John Peter Smith Hospital ( Site 0106)
Recruiting
Fort Worth, Texas, United States, 76104
Contacts
Study Coordinator
817-702-8049Oncology Consultants P.A. ( Site 0107)
Recruiting
Houston, Texas, United States, 77030
Contacts
Study Coordinator
713-600-0900Laguna Clinical Research Associates LLC ( Site 0068)
Recruiting
Laredo, Texas, United States, 78041
Contacts
Study Coordinator
956-724-8543Mays Cancer Center ( Site 0122)
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Study Coordinator
210-450-1000The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)
Recruiting
Tyler, Texas, United States, 75701
Contacts
Study Coordinator
903-592-6152Texas Oncology - Gulf Coast ( Site 8009)
Recruiting
Webster, Texas, United States, 77598
Contacts
Study Coordinator
281-332-7505Intermountain Medical Center ( Site 0113)
Recruiting
Murray, Utah, United States, 84107
Contacts
Study Coordinator
801-507-3630Mary Washington Hospital ( Site 0129)
Recruiting
Fredericksburg, Virginia, United States, 22405
Contacts
Study Coordinator
540-300-6182Hematology Oncology Associates of Fredericksburg ( Site 9550)
Recruiting
Fredericksburg, Virginia, United States, 22408
Contacts
Study Coordinator
540-371-0079Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
Recruiting
Midlothian, Virginia, United States, 23114
Contacts
Study Coordinator
804-893-8717Virginia Oncology Associates (VOA) ( Site 8008)
Recruiting
Norfolk, Virginia, United States, 23502
Contacts
Study Coordinator
646-694-8125Virginia Cancer Institute ( Site 0034)
Recruiting
Richmond, Virginia, United States, 23229
Contacts
Study Coordinator
804-287-3000Northwest Medical Specialties, PLLC ( Site 0093)
Recruiting
Tacoma, Washington, United States, 98405
Contacts
Study Coordinator
253-428-8700SSM Health Dean Medical Group ( Site 0087)
Recruiting
Madison, Wisconsin, United States, 53715
Contacts
Study Coordinator
516-488-2918Cross Cancer Institute ( Site 0407)
Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contacts
Study Coordinator
7804328956BC Cancer Vancouver ( Site 0404)
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contacts
Study Coordinator
6048776000CancerCare Manitoba ( Site 0411)
Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contacts
Study Coordinator
2047872127The Moncton Hospital ( Site 0401)
Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contacts
Study Coordinator
5068575756QEII Health Sciences Centre - Victoria General Site ( Site 0418)
Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contacts
Study Coordinator
9024732160Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0422)
Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contacts
Study Coordinator
613-549-6666Southlake Health ( Site 0413)
Recruiting
Newmarket, Ontario, Canada, L3Y 2P9
Contacts
Study Coordinator
9058954521x5155The Ottawa Hospital - General Campus ( Site 0414)
Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contacts
Study Coordinator
6137377700x70208North York General Hospital ( Site 0415)
Recruiting
Toronto, Ontario, Canada, M2K 1E1
Contacts
Study Coordinator
4167566000Princess Margaret Cancer Centre ( Site 0400)
Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contacts
Study Coordinator
4169464501x2245Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)
Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contacts
Study Coordinator
4504665000x3226CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contacts
Study Coordinator
5142523400x6244Centre Hospitalier de l'Université de Montréal ( Site 0403)
Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contacts
Study Coordinator
5148908000Jewish General Hospital ( Site 0416)
Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contacts
Study Coordinator
5143405222x27562Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)
Recruiting
Rimouski, Quebec, Canada, G5L 5T1
Contacts
Study Coordinator
4187243000x8029Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)
Recruiting
Trois-Rivières, Quebec, Canada, G8Z 3R9
Contacts
Study Coordinator
8196973333x63238Sponsor
Merck Sharp & Dohme LLC
Last update posted
Sep 3, 2026
Last verified
Sep, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.