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

Conditions

• Triple-Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — BIOLOGICAL
  Pembrolizumab 400 mg intravenous (IV) infusion q6w
• Sacituzumab tirumotecan — BIOLOGICAL
  Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
• Capecitabine — DRUG
  Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID

Study Details

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.

Key Dates

Start date

Jun 24, 2024

Status verified

Jun 2026

Primary completion

Dec 16, 2030

Completion

Dec 14, 2037

Study Design

Enrollment

1,530 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + sacituzumab tirumotecan
  Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan 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 sacituzumab tirumotecan infusions.
• 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.

Primary Outcome Measure

Invasive Disease-Free Survival (iDFS) [ Time Frame: Up to ~77 months ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (88)

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