A clinical study of sacituzumab tirumotecan with or without pembrolizumab in people with breast cancer (MK-2870-011)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

8 Jul 2025 → ongoing

Decision date (initial)

2025-07-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-516834-36-00

WHO UTN

U1111-1311-2310

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenetic, Pharmacoeconomic, Safety, Pharmacogenomic, Therapy, Pharmacokinetic

1. To compare sac-TMT to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
2. To compare sac-TMT plus pembrolizumab to TPC with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
3. To compare sac-TMT to TPC with respect to OS in all participants.

Secondary objectives 9

1. To compare sac-TMT plus pembrolizumab to TPC with respect to OS in all participants.
2. To compare sac-TMT plus pembrolizumab to sac-TMT with respect to PFS per RECIST 1.1 as assessed by BICR in all participants.
3. To compare sac-TMT to TPC with respect to ORR per RECIST 1.1 as assessed by BICR in all participants.
4. To compare sac-TMT plus pembrolizumab to TPC with respect to ORR per RECIST 1.1 as assessed by BICR in all participants
5. To compare sac-TMT plus pembrolizumab to sac-TMT with respect to OS in all participants.
6. To evaluate sac-TMT, sac-TMT plus pembrolizumab, and TPC with respect to DOR per RECIST 1.1 as assessed by BICR in all participants
7. To compare sac-TMT to TPC with respect to mean change from baseline in HRQoL using the EORTC QLQ-C30 in all participants.
8. To compare sac-TMT plus pembrolizumab to TPC with respect to mean change from baseline in HRQoL using the EORTC QLQ-C30 in all participants.
9. To evaluate the safety and tolerability of sac-TMT, sac-TMT plus pembrolizumab, and TPC.

Conditions and MedDRA coding

Locally recurrent unresectable or metastatic TNBC with tumors expressing PD-L1 at the cut-off of CPS <10

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Has locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) that cannot be treated with curative intent
2. Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
3. 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 (180 days) before the first disease recurrence
4. Is a candidate for treatment with pembrolizumab and one of the treatment of physician's choice (TPC) options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
5. Participants who have adverse events (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
6. Human Immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
7. 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
8. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion criteria 17

1. Has breast cancer amenable to treatment with curative intent
2. Has triple-negative breast cancer (TNBC) with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
3. Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
4. Has Grade ≥2 peripheral neuropathy
5. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
6. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
7. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
8. Has skin only metastatic disease
9. Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
10. Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
11. Has known additional malignancy that is progressing or has required active treatment within the past 5 years
12. 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
13. Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
14. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
15. Concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
16. History of stem cell/solid organ transplant
17. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)
2. Overall Survival (OS) (sac-TMT versus TPC)

Secondary endpoints 11

1. Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)
2. Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)
3. Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
4. Duration of Response (DOR)
5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
6. Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
8. Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
9. Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)
10. Number of participants who experience one or more adverse events (AEs)
11. Number of participants who discontinue study treatment due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 4

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Karen Lisa Smith

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Karen Lisa Smith

Third parties 7

Locations

13 EU/EEA countries · 80 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 100 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications