Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

SGN-LIV1A

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Immunoconjugates

Immunologic Factors

ladiratuzumab vedotin

Zejing Wang, MD, PhD

Kristel Apolinario, PharmD

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.

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.

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

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

Confirmed ORR as determined by investigator according to RECIST v 1.1

DOR as determined by investigator according to RECIST v 1.1

Proportion of patients with complete response (CR), partial response (PR), or stable disease (SD) as determined by investigator according to RECIST v 1.1

PFS as determined by investigator according to RECIST v 1.1

OS is defined as the time from start of study treatment to date of death due to any cause.

Merck Sharp & Dohme LLC

Seagen Inc.

Antibodies

Trastuzumab

Immunoglobulins

LV will be given at the recommended dose (at or below the monotherapy MTD determined in the LV dose escalation arm).

LV will be given into the vein (IV; intravenously)

Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)

Brandon Croft, PharmD

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.

A Safety Study of SGN-LIV1A in Breast Cancer Patients

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer

An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

To be summarized using descriptive statistics.

ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.

DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).

PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).

The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Lung Neoplasms

Small Cell Lung Carcinoma

Adenocarcinoma

Melanoma

Esophageal Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Small Cell Lung Cancer

Esophageal Cancer

200mg given by IV on Day 1 of each 21-day cycle

pembrolizumab

This trial will study ladiratuzumab vedotin (LV) alone and with pembrolizumab to find out if it works to treat different types of solid tumors. It will also find out what side effects may occur. A side effect is anything the drug does besides treating cancer.

This trial is designed to assess the antitumor activity, safety, and tolerability of LV alone and with pembrolizumab, for the treatment of solid tumors. Participants with the following advanced solid tumors will be enrolled:

Cohort 1: small cell lung cancer (SCLC) Cohort 2: non-small cell lung cancer-squamous (NSCLC-squamous) Cohort 3: non-small cell lung cancer-nonsquamous (NSCLC-nonsquamous) Cohort 4: head and neck squamous cell carcinoma (HNSCC) Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) Cohort 6: gastric and gastroesophageal junction (GEJ) adenocarcinoma Cohort 7: castration-resistant prostate cancer (CRPC) Cohort 8: melanoma

Participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the sponsor, pregnancy, or death, whichever comes first.

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors

Confirmed ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator.

Confirmed PSA response rate is defined as the proportion of participants with a reduction from baseline PSA level of at least 50%, measured twice ≥3 weeks apart.

An AE is any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

DCR is defined as the proportion of participants who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator, or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks or 7 weeks for prostate cancer subjects.

DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or death due to any cause, whichever comes first.

PSA-DOR is defined as the time from the first documentation of PSA response to the first documentation of PSA progression or death, whichever comes first

PFS is defined as the time from the start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD or by PSA progression (prostate cancer cohort) or death due to any cause, whichever comes first.

PSA-PFS is defined as the time from the start of study treatment to first occurrence of PSA progression or death, whichever comes first

OS is defined as the time from the start of study treatment to date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer	NCT03310957	Triple Negative...	ladiratuzumab v... Pembrolizumab	18 Years -	Seagen Inc.
A Safety Study of SGN-LIV1A in Breast Cancer Patients	NCT01969643	HER2 Positive B... Hormone Recepto... Triple Negative... HER2 Mutations ...	ladiratuzumab v... Trastuzumab	18 Years -	Seagen Inc.
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors	NCT04032704	Small Cell Lung... Non-small Cell ... Non-small Cell ... Head and Neck S... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Prostate Cancer Melanoma	ladiratuzumab v... pembrolizumab	18 Years -	Seagen Inc.
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors	NCT04032704	Small Cell Lung... Non-small Cell ... Non-small Cell ... Head and Neck S... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Prostate Cancer Melanoma	ladiratuzumab v... pembrolizumab	18 Years -	Seagen Inc.
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors	NCT04032704	Small Cell Lung... Non-small Cell ... Non-small Cell ... Head and Neck S... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Prostate Cancer Melanoma	ladiratuzumab v... pembrolizumab	18 Years -	Seagen Inc.
A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors	NCT04032704	Small Cell Lung... Non-small Cell ... Non-small Cell ... Head and Neck S... Esophageal Squa... Gastric Adenoca... Gastroesophagea... Prostate Cancer Melanoma	ladiratuzumab v... pembrolizumab	18 Years -	Seagen Inc.
A Safety Study of SGN-LIV1A in Breast Cancer Patients	NCT01969643	HER2 Positive B... Hormone Recepto... Triple Negative... HER2 Mutations ...	ladiratuzumab v... Trastuzumab	18 Years -	Seagen Inc.

Spots Global Cancer Trial Database for ladiratuzumab vedotin