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Monoclonal Antibodies

Ladiratuzumab Vedotin + Pembrolizumab for Advanced Cancers

Phase 2
Waitlist Available
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will study a new cancer drug to see if it is effective and what side effects it may cause.

Who is the study for?
This trial is for adults with various advanced solid tumors who have already tried certain treatments without success. Participants must be in good physical condition (ECOG score of 0 or 1) and have measurable disease. Specific criteria apply to different cancer types, like only one prior chemotherapy for some or progression after platinum-based therapy. People with active brain tumors, recent radiotherapy, significant ongoing treatment side effects, or other cancers within the last three years can't join.
What is being tested?
The study tests ladiratuzumab vedotin alone and combined with pembrolizumab on patients with solid tumors to see if it's effective and safe. It targets those whose cancer has progressed despite previous treatments including chemotherapy and immunotherapy.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, nerve damage symptoms like numbness or tingling (neuropathy), immune-related issues such as inflammation in organs which could manifest as coughing or diarrhea among others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed objective response rate (ORR) as determined by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Prostate-specific antigen (PSA) response rate as determined by investigator according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (Cohort 7 only)
Secondary study objectives
Area under the concentration-time curve (AUC)
Disease control rate (DCR) as determined by investigator according to RECIST v1.1
Duration of response (DOR) as determined by investigator according to RECIST v1.1
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part C - Arm 3: Randomized LV combination therapyExperimental Treatment2 Interventions
Combination dosing schedule 2.
Group II: Part C - Arm 2: Randomized LV combination therapyExperimental Treatment2 Interventions
Combination dosing schedule 1.
Group III: Part C - Arm 1: Randomized LV monotherapyExperimental Treatment1 Intervention
Monotherapy dosing schedule 3.
Group IV: Part B: Non-randomized LV monotherapyExperimental Treatment1 Intervention
Monotherapy dosing schedule 2.
Group V: Part A: Non-randomized LV monotherapyExperimental Treatment1 Intervention
Monotherapy dosing schedule 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890
ladiratuzumab vedotin
2013
Completed Phase 1
~290

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,028 Previous Clinical Trials
5,189,330 Total Patients Enrolled
4 Trials studying Esophageal Carcinoma
922 Patients Enrolled for Esophageal Carcinoma
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,133 Total Patients Enrolled
Zejing Wang, MD, PhDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
1,362 Total Patients Enrolled
Brandon Croft, PharmDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
701 Total Patients Enrolled
Sinhan Tran, PharmD, MBAStudy DirectorSeagen Inc.
2 Previous Clinical Trials
476 Total Patients Enrolled

Media Library

Ladiratuzumab Vedotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04032704 — Phase 2
Esophageal Carcinoma Research Study Groups: Part B: Non-randomized LV monotherapy, Part A: Non-randomized LV monotherapy, Part C - Arm 3: Randomized LV combination therapy, Part C - Arm 1: Randomized LV monotherapy, Part C - Arm 2: Randomized LV combination therapy
Esophageal Carcinoma Clinical Trial 2023: Ladiratuzumab Vedotin Highlights & Side Effects. Trial Name: NCT04032704 — Phase 2
Ladiratuzumab Vedotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04032704 — Phase 2
Esophageal Carcinoma Patient Testimony for trial: Trial Name: NCT04032704 — Phase 2
~33 spots leftby Dec 2025