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RECRUITING

NCT06393374

PHASE3

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Official title: A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1530

Start Date

2024-06-24

Completion Date

2037-12-14

Last Updated

2026-10-13

Healthy Volunteers

Conditions

Triple-Negative Breast Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Pembrolizumab 400 mg intravenous (IV) infusion q6w

BIOLOGICAL

Sacituzumab tirumotecan

Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID

Inclusion Criteria: * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC * Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery * Has non-pathologic complete response at surgery * Is able to continue on adjuvant pembrolizumab * Randomization must be conducted within 16 weeks from surgical resection * Completed adjuvant radiation therapy (if indicated) and recovered before randomization * Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception * For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available * Has Grade \>2 peripheral neuropathy * 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC * Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks * Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active hepatitis B and hepatitis C virus infection * Has history of allogeneic tissue/solid organ transplant

Locations (314)

Infirmary Cancer Care ( Site 0001)

Mobile, Alabama, United States

Ironwood Cancer & Research Centers-Research ( Site 0054)

Chandler, Arizona, United States

MemorialCare Orange Coast Medical Center ( Site 9501)

Fountain Valley, California, United States

Scripps Cancer Center ( Site 0052)

La Jolla, California, United States

Cancer and Blood Specialty Clinic ( Site 0008)

Los Alamitos, California, United States

Kaiser Permanente - Oakland ( Site 0079)

Oakland, California, United States

Profound Research LLC ( Site 0105)

Oceanside, California, United States

Kaiser Permanente - Roseville ( Site 0081)

Roseville, California, United States

Kaiser Permanente - San Francisco ( Site 0080)

San Francisco, California, United States

Kaiser Permanente - Santa Clara ( Site 0082)

Santa Clara, California, United States

Providence Medical Foundation ( Site 9543)

Santa Rosa, California, United States

Kaiser Permanente Vallejo Medical Center ( Site 0060)

Vallejo, California, United States

Kaiser Permanente - Walnut Creek ( Site 0078)

Walnut Creek, California, United States

Bass Medical Group ( Site 0089)

Walnut Creek, California, United States

Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)

Grand Junction, Colorado, United States

University of Connecticut Health Center ( Site 0128)

Farmington, Connecticut, United States

Yale Cancer Center ( Site 0053)

New Haven, Connecticut, United States

Helen F. Graham Cancer Center & Research Institute ( Site 0018)

Newark, Delaware, United States

AdventHealth Altamonte Springs ( Site 0125)

Altamonte Springs, Florida, United States

Orlando Health Cancer Institute ( Site 0030)

Orlando, Florida, United States

Comprehensive Hematology Oncology ( Site 0091)

St. Petersburg, Florida, United States

Cleveland Clinic Martin North Hospital ( Site 0114)

Stuart, Florida, United States

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)

Thomasville, Georgia, United States

Illinois Cancer Specialists (ICS) ( Site 8010)

Arlington Heights, Illinois, United States

Southern Illinois Hospital Services ( Site 9547)

Carterville, Illinois, United States

Orchard Healthcare Research Inc. ( Site 0014)

Skokie, Illinois, United States

Northwest Cancer Center - Dyer Clinic ( Site 0097)

Dyer, Indiana, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0011)

Fort Wayne, Indiana, United States

Cancer Center of Kansas ( Site 0004)

Wichita, Kansas, United States

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)

Edgewood, Kentucky, United States

CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)

Alexandria, Louisiana, United States

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)

Monroe, Louisiana, United States

Louisiana State University Health Sciences Shreveport ( Site 0029)

Shreveport, Louisiana, United States

Holy Cross Hospital ( Site 0069)

Silver Spring, Maryland, United States

University of Michigan ( Site 0103)

Ann Arbor, Michigan, United States

Henry Ford Health ( Site 0010)

Detroit, Michigan, United States

Profound Research LLC ( Site 0074)

Royal Oak, Michigan, United States

Metro-Minnesota Community Clinical Oncology ( Site 0031)

Saint Louis Park, Minnesota, United States

University of Mississippi Medical Center ( Site 0043)

Jackson, Mississippi, United States

SSM Health Cancer Care - Fenton ( Site 0088)

Fenton, Missouri, United States

Lake Regional Hospital ( Site 0009)

Osage Beach, Missouri, United States

Siteman Cancer Center ( Site 0099)

St Louis, Missouri, United States

Optum Care Cancer Center ( Site 9535)

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)

Las Vegas, Nevada, United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)

Albuquerque, New Mexico, United States

CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)

Santa Fe, New Mexico, United States

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)

New York, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0123)

New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0067)

New York, New York, United States

Clinical Research Alliance ( Site 0086)

Westbury, New York, United States

Levine Cancer Institute ( Site 0083)

Charlotte, North Carolina, United States

Cape Fear Valley Health System ( Site 0136)

Fayetteville, North Carolina, United States

Sanford Cancer Center Bismarck ( Site 0058)

Bismarck, North Dakota, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)

Fargo, North Dakota, United States

Altru Cancer Center ( Site 0104)

Grand Forks, North Dakota, United States

Cleveland Clinic - Mercy Hospital ( Site 0057)

Canton, Ohio, United States

Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)

Massillon, Ohio, United States

Taylor Cancer Research Center ( Site 9500)

Maumee, Ohio, United States

Genesis Healthcare System ( Site 0025)

Zanesville, Ohio, United States

Hightower Clinical, LLC ( Site 0085)

Oklahoma City, Oklahoma, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)

Tulsa, Oklahoma, United States

Providence Portland Medical Center ( Site 0116)

Portland, Oregon, United States

Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)

Portland, Oregon, United States

Sidney Kimmel Cancer Center at Jefferson ( Site 0049)

Philadelphia, Pennsylvania, United States

Cancer Care Associates Of York ( Site 9517)

York, Pennsylvania, United States

Sanford Cancer Center ( Site 0059)

Sioux Falls, South Dakota, United States

West Cancer Center and Research Institute ( Site 0084)

Germantown, Tennessee, United States

Baptist Cancer Center ( Site 0101)

Memphis, Tennessee, United States

One Oncology - Tennessee Oncology ( Site 0098)