Phase 2
Completed N=185
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Triple Negative Breast Neoplasms
Source: ClinicalTrials.gov NCT03310957 ↗
Enrolled (actual)
185
Serious AEs
51.3%
Results posted
Dec 2025
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 32; 59; 2; 53 Participants
Summary
This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
32; 59; 2; 53; 36; 17 | — |
| PRIMARY Number of Participants With Treatment Related TEAEs and SAEs |
29; 58; 2; 52; 35; 6 | — |
| PRIMARY Number of Participants With AEs of Grade <3 and Grade >=3 Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 |
10; 10; 0; 6; 5; 22 | — |
| PRIMARY Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Hematology Parameter |
2; 3; 0; 4; 2; 6 | — |
| PRIMARY Number of Participants With Maximum Post-Baseline Laboratory Toxicity Grade (0 to 4) in Any Serum Chemistry Parameter |
10; 9; 1; 4; 12; 6 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLT): Part A and Part C |
0; 2; 0; 0 | — |
| PRIMARY ORR as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 |
34; 41; 50; 47; 39 | — |
| SECONDARY Duration of Response (DOR) Per RECIST v1.1 |
4.5; 5.8; 4.2; 4.4; 8.3 | — |
| SECONDARY Disease Control Rate (DCR) |
59; 81; 50; 77; 69 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.5; 4.2; 3.3; 4.8; 4.2 | — |
| SECONDARY Overall Survival (OS) |
14.6; 14.8; NA; 19.4; NA | — |
Eligibility Criteria
Inclusion Criteria
- Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- Part D only: Tumor tissue PD-L1 Combined Positive Score <10 expression.
- Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer
- At least 6 months since prior treatment with curative intent and recurrence
- At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to provide biopsy tissue for biomarker analysis
- Meet baseline laboratory data criteria
Exclusion Criteria
- Prior immune-oncology therapy
- Pre-existing neuropathy of at least Grade 2
- History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids.
- Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy
- Active autoimmune disease requiring systemic treatment within the past 2 years
- History of interstitial lung disease
- Current pneumonitis or history of pneumonitis requiring steroids
Data sourced from ClinicalTrials.gov (NCT03310957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.