Description:
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 the 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.
Title
- Brief Title: Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
- Official Title: Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
SGNLVA-002
- SECONDARY ID:
KEYNOTE 721
- SECONDARY ID:
2017-002289-35
- NCT ID:
NCT03310957
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ladiratuzumab vedotin | LV, SGN-LIV1A | LV plus pembrolizumab |
Pembrolizumab | Keytruda | LV plus pembrolizumab |
Purpose
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 the 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.
Detailed Description
The primary goal of this study is to evaluate the combination of LV, which targets LIV-1-
expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with
unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs
act through distinct and possibly complementary modes of action.
This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab
during dose escalation will be monitored for frequency of dose-limiting toxicities to
determine a recommended doses for expansion cohorts. In addition to safety measures,
objective response rate, progression-free survival, overall survival, and other efficacy
outcomes will be assessed.
Trial Arms
Name | Type | Description | Interventions |
---|
LV plus pembrolizumab | Experimental | LV + pembrolizumab | - ladiratuzumab vedotin
- Pembrolizumab
|
Eligibility Criteria
Inclusion Criteria:
- Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER,
and PR 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Confirmed objective response rate |
Time Frame: | Up to 18 weeks following last dose; approximately 1 year |
Safety Issue: | |
Description: | Confirmed ORR as determined by investigator according to RECIST v 1.1 |
Secondary Outcome Measures
Measure: | Duration of response |
Time Frame: | Up to 2.5 years following last dose |
Safety Issue: | |
Description: | DOR as determined by investigator according to RECIST v 1.1 |
Measure: | Disease control rate |
Time Frame: | Up to 2.5 years following last dose |
Safety Issue: | |
Description: | Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1 |
Measure: | Progression-free survival |
Time Frame: | Up to 2.5 years following last dose |
Safety Issue: | |
Description: | PFS as determined by investigator according to RECIST v 1.1 |
Measure: | Overall survival |
Time Frame: | Up to 2.5 years following last dose |
Safety Issue: | |
Description: | OS is defined as the time from start of study treatment to date of death due to any cause. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- Breast cancer
- Breast carcinoma
- Triple negative breast cancer
- Locally-advanced breast cancer
- Metastatic breast cancer
- Tumors, breast
- Breast tumors
- pembrolizumab
- LIV-1 protein, human
- Ladiratuzumab vedotin
- hLIV22-vcMMAE
- Seattle Genetics
Last Updated
August 17, 2021