Study

Overview

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

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.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1530

Study Start Date:

June 2024

Estimated Study Completion Date:

December 2037

Estimated Primary Completion Date:

December 2030

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

CRITERIA

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

United States Toll Free Number 1-800-770-4674

Mobile, Alabama, 36607
Chandler, Arizona, 85224
La Jolla, California, 92037
Oakland, California, 94611
Oceanside, California, 92056
Roseville, California, 95661
San Francisco, California, 94115
Santa Clara, California, 95051
Vallejo, California, 94589
Walnut Creek, California, 94596
Walnut Creek, California, 94598
New Haven, Connecticut, 06510
St. Petersburg, Florida, 33709
Thomasville, Georgia, 31792
Skokie, Illinois, 60077
Dyer, Indiana, 46311
Fort Wayne, Indiana, 46845
Monroe, Louisiana, 71202
Shreveport, Louisiana, 71103
Silver Spring, Maryland, 20910
Royal Oak, Michigan, 48073
Jackson, Mississippi, 39213
Fenton, Missouri, 63026
Osage Beach, Missouri, 65065
Albuquerque, New Mexico, 87109
New York, New York, 10065
Westbury, New York, 11590
Bismarck, North Dakota, 58501
Fargo, North Dakota, 58122
Grand Forks, North Dakota, 58201
Canton, Ohio, 44708
Massillon, Ohio, 44646
Zanesville, Ohio, 43701
Oklahoma City, Oklahoma, 73102
Tulsa, Oklahoma, 74146
Philadelphia, Pennsylvania, 19107
Sioux falls, South Dakota, 57104
Germantown, Tennessee, 38138
Memphis, Tennessee, 38120
Nashville, Tennessee, 37203
Nashville, Tennessee, 37203
Nashville, Tennessee, 37208
Amarillo, Texas, 79106
Dallas, Texas, 75390
Dallas, Texas, 75390
Flower Mound, Texas, 75028
Laredo, Texas, 78045
Tyler, Texas, 75701
Midlothian, Virginia, 23114
Richmond, Virginia, 23229
Tacoma, Washington, 98405
Madison, Wisconsin, 53715

Canada Study Coordinator 5068575756

Results

No Study Results Posted

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results