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Checkpoint Inhibitor
T-VEC + Pembrolizumab for Sarcoma
Phase 2
Waitlist Available
Led By Ciara Kelly, MBBCh BAO
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For histology specific additional metastatic cohorts, patients must have undifferentiated pleomorphic sarcoma/myxofibrosarcoma, epithelioid sarcoma or cutaneous angiosarcoma
Histologically confirmed metastatic and/or locally advanced inoperable sarcoma (metastatic/locally advanced cohort)
Must not have
Presence of any other concurrent active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Summary
This trial is testing a new cancer treatment that uses two drugs.
Who is the study for?
Adults with advanced sarcoma, including specific types like epithelioid and cutaneous angiosarcoma, who have tried at least one systemic therapy or refused standard treatment. Participants must be in good health otherwise, not pregnant or breastfeeding, willing to use contraception, and able to give informed consent.
What is being tested?
The trial is testing a combination of two drugs: T-VEC (Talimogene Laherparepvec) and Pembrolizumab for treating patients with sarcoma. It aims to see how well these drugs work together against this type of cancer.
What are the potential side effects?
Possible side effects include reactions at the injection site for T-VEC, flu-like symptoms such as fever and chills; fatigue; skin rash; muscle pain; and immune-related issues like inflammation in organs due to Pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of the specific types: undifferentiated pleomorphic sarcoma, myxofibrosarcoma, epithelioid sarcoma, or cutaneous angiosarcoma.
Select...
My sarcoma cannot be removed by surgery and has spread.
Select...
I am fully active or able to carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have another active cancer besides the one being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
best objective response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Talimogene Laherparepvec (T-VEC) Administered with PembrolizuExperimental Treatment2 Interventions
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Talimogene Laherparepvec (T-VEC)
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,420 Previous Clinical Trials
1,382,909 Total Patients Enrolled
12 Trials studying Sarcoma
1,847 Patients Enrolled for Sarcoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,942 Total Patients Enrolled
32 Trials studying Sarcoma
3,902 Patients Enrolled for Sarcoma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,515 Total Patients Enrolled
70 Trials studying Sarcoma
13,670 Patients Enrolled for Sarcoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Criterion: You are sensitive to talimogene laherparepvec or pembrolizumab, or have a history of lung disease. You have received certain treatments or surgeries within 21 days before the study starts, are currently in another clinical trial, or have had psychiatric or substance abuse issues.My brain metastases are stable and haven't progressed in the last 4 weeks.Women who could become pregnant must have a negative pregnancy test before starting the study.My cancer is one of the specific types: undifferentiated pleomorphic sarcoma, myxofibrosarcoma, epithelioid sarcoma, or cutaneous angiosarcoma.I do not have a weakened immune system due to conditions like HIV, autoimmune diseases, or recent live vaccines.I have a tumor or node that can be injected, is at least 10mm big, and hasn't been previously treated with radiation unless it's grown.My organs are functioning well, as tested within the last 3 weeks.I have advanced sarcoma and have either tried a treatment, there's no standard treatment for my type, or I've refused standard treatment.I do not have any uncontrolled illnesses or infections needing treatment.I am 18 years old or older.My sarcoma cannot be removed by surgery and has spread.I am fully active or able to carry out light work.I have another active cancer besides the one being treated.
Research Study Groups:
This trial has the following groups:- Group 1: Talimogene Laherparepvec (T-VEC) Administered with Pembrolizu
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.
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