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New treatment option for Sarcoma
Official title Talimogene Laherparepvec, Nivolumab and Trabectedin for Sarcoma
ClinicalTrials.gov ID: NCT03886311
What this study is testing
What is Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]?
Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC] is an investigational medicine, being studied as a potential treatment for sarcoma.
Also referred to as TVEC, Imlygic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2 study using talimogene laherparepvec, nivolumab, and trabectedin as first, second or third line therapy for advanced sarcoma, including desmoid tumor and chordoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals must meet all of the in order to be eligible to participate in the study, as follows:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's...
- Willingness to comply with all study procedures and availability for the duration of the study.
You likely can't join if
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:
- Known active central nervous system (CNS) metastases. people with previously treated brain metastases may participate provided they are stable...
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or...
- Evidence of clinically significant immunosuppression such as the following: - Primary immunodeficiency state such as Severe Combined Immunodeficiency...
- Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent...
See the full eligibility criteria
Who can join
- Individuals must meet all of the in order to be eligible to participate in the study, as follows:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic sarcoma including desmoid tumor and chordoma
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of the study.
- Previously untreated or treated patient with measurable disease by RECIST v1.1, and at least, one accessible tumor for intratumoral injection of TALIMOGENE LAHERPAREPVEC
- ECOG performance status ≤ 1
- Life expectancy of at least 3 months
- Acceptable liver function: Bilirubin \<1.5 times upper limit of normal (ULN; except people with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \< 2.5 x ULN (\< 5...
- Acceptable renal function: Creatinine \< 1.5 times ULN
- Acceptable hematologic status: ANC \>1500 cells/μL or greater; Platelet count \>100,000/μL or greater; Hemoglobin \> 9.0 g/dL or greater
- INR and PT \< 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants
- All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be...
What rules you out
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation, as follows:
- Known active central nervous system (CNS) metastases. people with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to...
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or...
- Evidence of clinically significant immunosuppression such as the following: - Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease. - concurrent opportunistic infection. - receiving systemic...
- Active herpetic skin lesions or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
- Previous treatment with TALIMOGENE LAHERPAREPVEC or any other oncolytic virus.
- Received live vaccine within 28 days prior to study treatment.
- Prior immunosuppressive, chemotherapy, radiotherapy (in which the field encompassed a planned injection site), biological cancer therapy, or major surgery within 28 days prior to study treatment or has not recovered to...
- Prior radiotherapy in which the field does not overlap the injection sites or nonimmunosuppressive targeted therapy within 14 days prior to study treatment or has not recovered to CTCAE grade 1 or better from adverse...
- Currently receiving treatment with another investigational device or drug study, or \< 28 days since ending treatment with another investigational device or drug study(s).
- Other investigational procedures while participating in this study are excluded.
- Known to have acute or chronic active hepatitis B infection.
- Known to have acute or chronic active hepatitis C infection.
- Known to have human immunodeficiency virus (HIV) infection.
- History of other malignancy within the past 5 years with the following exceptions:
- Adequately treated non melanoma skin cancer without evidence of disease at the time of enrollment;
- Adequately treated cervical carcinoma in situ without evidence of disease at the time of enrollment;
- Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of enrollment;
- Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of enrollment.
- Subject has known sensitivity to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN or any of its components to be administered during dosing.
- Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or TRABECTEDIN.
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of TALIMOGENE LAHERPAREPVEC, NIVOLUMAB or...
- Sexually active people and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with TALIMOGENE...
- people who are unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications such as immunosuppressed individuals, individuals known to...
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.