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A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)

Sac-TMT+-pembrolizumab vs TPC in 1L unresectable/metastatic TNBC (PD-L1 CPS<10)

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

May. 30, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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 TNBC
- 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 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

- 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 TNBC
- Has Grade >=2 peripheral neuropathy
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or 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

Both

Triple-Negative Breast Cancer

Arm A : MK-2870
Participants receive MK-2870 intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until one of the criteria for discontinuation are met. Additionally, participants may receive rescue medication per approved product label, at the discretion of the investigator.

Arm B : MK-2870 + MK-3475
Participants receive MK-2870 IV 4 mg/kg Q2W until one of the criteria for discontinuation are met PLUS MK-3475 IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years). Additionally, participants may receive rescue medication per approved product label, at the discretion of the investigator.

Arm C : Treatment of Physician's Choice
Participants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m2 once every week (Q1W) OR paclitaxel IV 90 mg/m2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV AUC2 on Days 1 and 8, Q3W, until one of the criteria for discontinuation are met.

- To compare MK-2870 to TPC with respect to progression-free survival (PFS)
- To compare MK-2870 plus MK-3475 to TPC with respect to PFS
- To compare MK-2870 to TPC with respect to overall survival (OS)

- To compare MK-2870 plus MK-3475 to TPC with respect to OS
- To compare MK-2870 plus MK-3475 to MK-2870 with respect to PFS
- To compare MK-2870 to TPC with respect to objective response rate (ORR)
- To compare MK-2870 plus MK-3475 to TPC with respect to ORR
- duration of response
- health-related quality of life
- safety and tolerability

+81-3-3784-8305

April. 15, 2025

Yes

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