A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
Purpose
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
Condition
- Triple Negative Breast Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
The main inclusion criteria include but are not limited to the following: - Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent - Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer - Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence - Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin - Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load - Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has breast cancer amenable to treatment with curative intent - Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10 - Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer - Has Grade ≥2 peripheral neuropathy - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has skin only metastatic disease - Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications - Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease - Has known additional malignancy that is progressing or has required active treatment within the past 5 years - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable - Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection - History of stem cell/solid organ transplant - Has not adequately recovered from major surgery or has ongoing surgical complications
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Sacituzumab Tirumotecan |
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation. |
|
|
Experimental Arm B: Sacituzumab Tirumotecan + Pembrolizumab |
Participants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). |
|
|
Active Comparator Arm C: Treatment of Physician's Choice (TPC) |
Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m^2 once every week (Q1W) OR paclitaxel IV 90 mg/m^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation. |
|
Recruiting Locations
Mobile 4076598, Alabama 4829764 36604
Study Coordinator
251-410-4924
Chandler 5289282, Arizona 5551752 85224
Study Coordinator
623-312-3000
Duarte 5344147, California 5332921 91010
Study Coordinator
626-218-9845
Irvine 5359777, California 5332921 92618
Study Coordinator
626-218-0720
Los Angeles 5368361, California 5332921 90095
Study Coordinator
650-283-5067
San Francisco 5391959, California 5332921 94158
Study Coordinator
415-353-7070
New Haven 4839366, Connecticut 4831725 06510
Study Coordinator
203-200-3100
Washington D.C. 4140963, District of Columbia 4138106 20010-2975
Study Coordinator
202-877-8839
Altamonte Springs 4145941, Florida 4155751 32701
Study Coordinator
407-303-2284
West Palm Beach 4177887, Florida 4155751 33401
Study Coordinator
561-366-4100
Athens 4180386, Georgia 4197000 30607
Study Coordinator
706-353-2990
Boise 5586437, Idaho 5596512 83712
Study Coordinator
208-381-2711
Chicago 4887398, Illinois 4896861 60612
Study Coordinator
312-996-1581
Baltimore 4347778, Maryland 4361885 21237
Study Coordinator
443-777-7147
Baltimore 4347778, Maryland 4361885 21239
Study Coordinator
443-777-7147
Olney 4364537, Maryland 4361885 20832
Study Coordinator
301-774-8882
Silver Spring 4369596, Maryland 4361885 20910
Study Coordinator
301-754-7552
Minneapolis 5037649, Minnesota 5037779 55407
Study Coordinator
763-577-7000
Las Vegas 5506956, Nevada 5509151 89119
Study Coordinator
702-952-3350
Reno 5511077, Nevada 5509151 89502
Study Coordinator
775-982-5050
Hackensack 5098706, New Jersey 5101760 07601
Study Coordinator
551-996-5900
Albuquerque 5454711, New Mexico 5481136 87109
Study Coordinator
505-842-8171
Mineola 5127134, New York 5128638 11501
Study Coordinator
516-663-9500
New York 5128581, New York 5128638 10016
Study Coordinator
212-731-6126
Raleigh 4487042, North Carolina 4482348 27607
Study Coordinator
919-784-7209
Nashville 4644585, Tennessee 4662168 37203
Study Coordinator
615-329-7274
Dallas 4684888, Texas 4736286 75231
Study Coordinator
214-739-4175
El Paso 5520993, Texas 4736286 79902
Study Coordinator
915-747-4835
Houston 4699066, Texas 4736286 77005
Study Coordinator
713-239-4510
Houston 4699066, Texas 4736286 77014
Study Coordinator
713-239-4510
San Antonio 4726206, Texas 4736286 78240
Study Coordinator
210-419-2608
Norfolk 4776222, Virginia 6254928 23502
Study Coordinator
757-368-5033
Seattle 5809844, Washington 5815135 98109
Study Coordinator
206-606-6329
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC