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NCT06393374 | Not yet recruiting | Triple-Negative Breast Cancer

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

Merck Sharp & Dohme LLC

Brief Summary:

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (sac-TMT; 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 sac-TMT plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sac-TMT plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Condition or disease

Triple-Negative Breast Cancer

Intervention/treatment

Pembrolizumab

sac-TMT

Capecitabine

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 1530 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : May 24, 2024
Estimated Primary Completion Date : December 16, 2030
Estimated Study Completion Date : December 14, 2037
Arm Intervention/treatment

Experimental: Pembrolizumab + sac-TMT

Participants receive pembrolizumab every 6 weeks (q6w) in combination with sac-TMT every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sac-TMT infusions.

Biological: Pembrolizumab

Biological: sac-TMT

Active Comparator: Treatment of Physician's Choice

Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily [BID] on Days 1 to 14 and 22 to 35 every 42 days x 4 [2 weeks 1, 1 week off]) for 24 weeks.

Biological: Pembrolizumab

Drug: Capecitabine
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 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 12 weeks from surgical resection
  • Completed adjuvant radiation therapy (if indicated) and recovered for any toxicity before randomization
  • For male participants, agrees to refrain from donating sperm and either abstains from penile-vaginal intercourse or uses approved contraception for 100 days after the last dose of sac-TMT and 95 days after the last dose of capecitabine
  • For female participants, is not a participant of childbearing potential (POCBP) or is a POCBP and uses highly effective contraception; agrees not to donate eggs for up to 190 days after the last dose of sac-TMT, 120 days after the last dose of pembrolizumab, and 185 days after the last dose of capecitabine; has a negative highly sensitive pregnancy test before the first dose of study intervention; and agrees to abstain from breastfeeding for at least 120 days after last dose of study therapy
  • HIV-infected participants must have well controlled HIV on ART
  • An ECOG performance status of 0 to 1 assessed within 7 days before first dose of study treatment
  • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
Exclusion Criteria
  • Has gBRCA mutation and resides in a region where olaparib is approved/reimbursed/used to treat germline BRCA-mutated (gBRCAm) tumors
  • Has received current or prior treatment with a PARP inhibitor, regardless of BRCA mutation status
  • Has Grade >2 peripheral neuropathy
  • 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 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 anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, PARP inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
  • Is currently receiving a strong and/or moderate inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study
  • Received prior radiotherapy within 3 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR

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

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