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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
+7 moreTrial 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
~5750
ladiratuzumab vedotin
2013
Completed Phase 1
~290
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,366 Total Patients Enrolled
Seagen Inc.Lead Sponsor
207 Previous Clinical Trials
68,952 Total Patients Enrolled
Zejing Wang, MD, PhDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
1,466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Group 1: Small cell lung cancer (Parts A and B)You must have advanced stage cancer.You have only received one type of chemotherapy for advanced stage cancer.This applies to all groups of people being considered.You must have had your disease get worse during or after receiving chemotherapy with a certain type of medication called platinum-based systemic chemotherapy for extensive stage disease.You have a measurable disease as determined by the doctor, and you have a good ability to perform daily activities.You have advanced or metastatic non-small cell lung cancer and have seen your disease get worse after receiving certain types of treatments. You have also received specific types of chemotherapy and immunotherapy.You have prostate cancer that has spread and no more than one prior treatment with certain types of medication. You must not have certain genetic mutations or recent radiotherapy.You have a history of a certain type of lung disease.You have a measurable disease that can be assessed by the investigator using specific guidelines.You have advanced esophageal cancer that cannot be removed by surgery, and you have tried one type of strong medicine for your cancer.If you have stomach or gastroesophageal junction cancer that cannot be removed with surgery and has spread, you must have already tried a specific type of chemotherapy and your cancer must have gotten worse despite that treatment. If you have a certain protein called HER2 in your cancer, you must have already tried a treatment that targets that protein. You should not have tried more than one type of chemotherapy for your advanced cancer. You may have already tried a treatment that works by blocking a certain protein, unless it was not safe for you to do so.You must have a confirmed diagnosis of skin melanoma, and not have mucosal, acral, or uveal melanoma. Your melanoma should be at an advanced stage and have continued to grow after anti-PD(L)1 treatment. If your melanoma has a specific genetic mutation, you should have already received certain medications.You have another cancer that is growing, or you had cancer in the past 3 years.You have active brain or spinal cord lesions.Criterion: For people with head and neck cancer, the cancer must be inoperable and have either come back in the same place or spread to other parts of the body. The cancer must have gotten worse during or after previous treatment with medicines, including platinum-containing drugs. If the cancer came back within 6 months of receiving platinum therapy as part of a combined treatment, only one round of chemotherapy is allowed. Prior treatment with anti-PD(L)1 therapy is allowed unless it's not recommended for the participant.You have an ECOG performance score of 0 or 1.For this group, you must have extensive stage small cell lung cancer and your disease must have gotten worse after getting chemotherapy. You should have only had one round of chemotherapy for this stage of cancer and you may have had a type of immunotherapy called anti-PD(L)1 before.You have not had any cancer treatment within the past 3 weeks, except for hormonal therapy to prevent cancer from spreading.You are currently experiencing serious side effects from a previous treatment.You have moderate or severe ongoing numbness or weakness in your hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Non-randomized LV monotherapy
- Group 2: Part A: Non-randomized LV monotherapy
- Group 3: Part C - Arm 3: Randomized LV combination therapy
- Group 4: Part C - Arm 1: Randomized LV monotherapy
- Group 5: Part C - Arm 2: Randomized LV combination therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Esophageal Cancer Patient Testimony for trial: Trial Name: NCT04032704 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for participants in this clinical trial?
"Affirmative. Clinicaltrials.gov portrays that this clinical trial, originally posted on October 9th 2019, is now recruiting participants. A total of 264 patients should be recruited from 23 different medical centres."
Answered by AI
How many individuals have enrolled in this research initiative?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is actively accepting participants and was first posted October 9th 2019 before being updated most recently October 28th 2022. 264 patients need to be recruited from 23 different sites for this study."
Answered by AI
What is the geographic scope of this scientific evaluation?
"Presently, 23 medical centres are offering this clinical trial. Of those locations, Decatur, Jacksonville and Chicago can be found in the list. It is recommended that potential participants join a location close to them to reduce travel burdens."
Answered by AI
Could you provide information on the prior experiments that have been conducted utilizing ladiratuzumab vedotin?
"Presently, there are 5 active clinical trials for ladiratuzumab vedotin. Not one of these experimental protocols is in Phase 3 yet. Most studies take place in Saint Louis, Missouri; however, 236 different locations across the nation have some form of trial running related to this drug therapy."
Answered by AI
Is ladiratuzumab vedotin a secure treatment option for individuals?
"Our research team has assessed the safety of ladiratuzumab vedotin to be a 2 due to its Phase 2 designation. This implies some existing data pertaining to safety, but no evidence yet regarding efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Joe Arrington Cancer Research and Treatment Center
UT Health East Texas Hope Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I've just received my diagnosis of prostate cancer and I'm interested in differing treatment options other than radical prostatectomy.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
is the risk of undertaking this trial increase my chances of needing a radical prostatectomy sooner?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- Joe Arrington Cancer Research and Treatment Center: < 24 hours
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