Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Sarcoma Oncology Research Center, LLC
Must not be taking: Antiherpetics, Immunosuppressives
Disqualifiers: CNS metastases, Autoimmune disease, HIV, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy or antiherpetic drugs, you may need to stop them before participating.
What data supports the effectiveness of the treatment combination of Nivolumab, Opdivo, Talimogene Laherparepvec, Imlygic, T-VEC, Oncovex, Trabectedin, Yondelis for sarcoma?
Research shows that Talimogene Laherparepvec (T-VEC) can boost the immune system's response to tumors, and when combined with other drugs like Pembrolizumab, it has been effective in treating sarcomas. Additionally, the combination of T-VEC with Trabectedin and Nivolumab may work together to enhance treatment effects in advanced sarcomas.
12345Is the combination therapy for sarcoma generally safe for humans?
The combination of talimogene laherparepvec (T-VEC) with other drugs like pembrolizumab and ipilimumab has shown an acceptable safety profile in patients with advanced melanoma, suggesting it is generally safe for humans.
12367How is the combination therapy for sarcoma different from other treatments?
This treatment is unique because it combines talimogene laherparepvec (an oncolytic virus that helps the immune system attack cancer cells) with nivolumab and trabectedin, potentially creating a stronger immune response against advanced sarcomas compared to using each drug alone.
12368Eligibility Criteria
Adults with advanced sarcoma, including desmoid tumor and chordoma, who are fit (ECOG β€ 1) and have a life expectancy of at least 3 months. They must be able to understand the study, consent to it, and agree to use effective contraception. Those with certain organ functions within specific limits can join. People with active herpes infections or recent treatments that could interfere are excluded.Inclusion Criteria
My sarcoma cannot be surgically removed or has spread.
I am fully active and can carry on all pre-disease activities without restriction.
My kidney function is normal, with creatinine levels less than 1.5 times the upper limit.
I have a tumor that can be measured and reached for treatment.
Exclusion Criteria
I am on medication for an autoimmune disease, not including hormone replacements.
I am allergic to TALIMOGENE LAHERPAREPVEC, NIVOLUMAB, or TRABECTEDIN.
I need regular medication for herpes, not just cream.
I am willing to use condoms during and 30 days after treatment.
I have an active hepatitis B infection.
I have an active hepatitis C infection.
I have a weak immune system due to a condition or medication.
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
I have been treated with TALIMOGENE LAHERPAREPVEC or another virus-based cancer therapy.
Participant Groups
The trial is testing talimogene laherparepvec, nivolumab, and trabectedin as potential first to third line therapies for advanced sarcoma. It's a Phase 2 study where these drugs are given in combination to see how well they work together against this type of cancer.
1Treatment groups
Experimental Treatment
Group I: Talimogene laherparepvec, Nivolumab and TrabectedinExperimental Treatment3 Interventions
This is an open label phase 2 study using known doses of TALIMOGENE LAHERPAREPVEC injected intratumorally, and NIVOLUMAB AND TRABECTEDIN given intravenously.
A total of 40 previously untreated and treated patients will receive TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks, NIVOLUMAB 240 mg IV over 30 min q 2 weeks and TALIMOGENE LAHERPAREPVEC intratumorally q 2 weeks according to tumor size (see Schematic of Study Design and Imlygic product information; www.accessdata.fda.gov). Patients in this study may continue treatment until significant disease progression (see below for criteria for discontinuation of therapy) or unacceptable toxicity occurs up to one year of therapy.
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
πΊπΈ Approved in United States as Opdivo for:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
πͺπΊ Approved in European Union as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
π¨π¦ Approved in Canada as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
π¨π Approved in Switzerland as Opdivo for:
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Sarcoma Oncology CenterSanta Monica, CA
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Who is running the clinical trial?
Sarcoma Oncology Research Center, LLCLead Sponsor
References
Talimogene Laherparepvec plus Pembrolizumab Is Effective in Sarcomas. [2020]Pembrolizumab with the oncolytic virus talimogene laherparepvec was effective in treating sarcomas.
Activity of TNT: a phase 2 study using talimogene laherparepvec, nivolumab and trabectedin for previously treated patients with advanced sarcomas (NCT# 03886311). [2023]Intratumoral injection of talimogene laherparepvec evokes a cytotoxic immune response. Therefore, the combination of talimogene laherparepvec with trabectedin and nivolumab may have synergistic effects in advanced sarcomas.
Objective Response Rate Among Patients With Locally Advanced or Metastatic Sarcoma Treated With Talimogene Laherparepvec in Combination With Pembrolizumab: A Phase 2 Clinical Trial. [2023]Patients with advanced sarcoma have limited treatment options. Talimogene laherparepvec (T-VEC) has been shown to increase tumor-specific immune activation via augmenting antigen presentation and T-cell priming.
Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. [2023]Few standard treatment options are available for patients with metastatic sarcomas. We did this trial to evaluate the efficacy, safety, and changes in the tumour microenvironment for durvalumab, an anti-PD-L1 drug, and tremelimumab, an anti-CTLA-4 drug, across multiple sarcoma subtypes.
Is there still a role for talimogene laherparepvec (T-VEC) in advanced melanoma? An indirect efficacy comparison of T-VEC plus ipilimumab combination therapy versus T-VEC alone as salvage therapy in unresectable metastatic melanoma. [2022]Talimogene laherparepvec (T-VEC) improves overall survival (OS) in unresectable stage IIIB/C-IV melanoma T-VEC may have synergistic effects with CTLA-4 inhibitors In the absence of a trial comparing T-VEC and ipilimumab (T-VEC + IPI) to T-VEC, we applied a novel indirect comparison method using extrapolated OS curves to estimate OS outcomes in a simulated trial comparing both regimens in stage IIIB/C-IV unresectable melanoma.
Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma. [2022]Combining immunotherapeutic agents with different mechanisms of action may enhance efficacy. We describe the safety and efficacy of talimogene laherparepvec (T-VEC; an oncolytic virus) in combination with ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 checkpoint inhibitor) in patients with advanced melanoma.
Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. [2023]The combination of talimogene laherparepvec (T-VEC) and pembrolizumab previously demonstrated an acceptable safety profile and an encouraging complete response rate (CRR) in patients with advanced melanoma in a phase Ib study. We report the efficacy and safety from a phase III, randomized, double-blind, multicenter, international study of T-VEC plus pembrolizumab (T-VEC-pembrolizumab) versus placebo plus pembrolizumab (placebo-pembrolizumab) in patients with advanced melanoma.
Phase Ib study of talimogene laherparepvec in combination with atezolizumab in patients with triple negative breast cancer and colorectal cancer with liver metastases. [2023]Talimogene laherparepvec (T-VEC), a first-in-class oncolytic viral immunotherapy, enhances tumor-specific immune activation. T-VEC combined with atezolizumab, which blocks inhibitor T-cell checkpoints, could provide greater benefit than either agent alone. Safety/efficacy of the combination was explored in patients with triple negative breast cancer (TNBC) or colorectal cancer (CRC) with liver metastases.