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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 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
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 moreAwards & 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
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,022 Total Patients Enrolled
4 Trials studying Esophageal Carcinoma
922 Patients Enrolled for Esophageal Carcinoma
Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,225 Total Patients Enrolled
Zejing Wang, MD, PhDStudy DirectorSeagen Inc.
3 Previous Clinical Trials
1,362 Total Patients Enrolled
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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 Carcinoma Patient Testimony for trial: Trial Name: NCT04032704 — Phase 2
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