Solid Tumor study: T3011 vs T3011 + pembrolizumab
Official title A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT04370587
What this study is testing
What is T3011?
T3011 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for solid tumor.
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
- The study aims to see if T3011 is safe and shows early signs of working, both by itself and together with pembrolizumab.
- Who it's for
- Adults who have advanced or metastatic solid tumors such as melanoma, head‑and‑neck cancer, sarcoma, squamous cell cancer, or non‑small cell lung cancer.
- What's involved
- Participants receive an injection of T3011 directly into a tumor and may also get an IV infusion of pembrolizumab, along with regular clinic visits for exams, scans and lab tests.
- Time commitment
- The trial runs for several months and includes multiple visits for treatment and follow‑up assessments.
- 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
- Age 18 years or older.
- Disease progression after standard of care (SOC) therapy or in the opinion of
- The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or...
- Measurable disease per RECIST version 1.1.
- Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
You likely can't join if
- Have only uninjectable tumors..
- Patients with injectable tumors impinging upon major airways or blood vessels.
- HNSCC only: Prior re-irradiation field containing carotid artery.
- Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm...
- Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
- Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
See the full eligibility criteria
- Age 18 years or older.
- Disease progression after standard of care (SOC) therapy or in the opinion of
- The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy. Phase 2a Part 1 i.
- Measurable disease per RECIST version 1.1.
- Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Life expectancy \> 12 weeks.
- Demonstrate adequate organ function as defined by acceptable laboratory testing results.
- Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011.
- Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \> 21 days, or surgical intervention \> 21 days prior to the first dose of T3011.
- Recovered from all prior anticancer therapy toxicities.
- Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.
- Capable of understanding and complying with protocol requirements.
- Signed and dated institutional review board/independent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed. Key
- Have only uninjectable tumors..
- Patients with injectable tumors impinging upon major airways or blood vessels.
- HNSCC only: Prior re-irradiation field containing carotid artery.
- Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.
- Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
- Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
- Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
- Requires continued concurrent therapy with any drug active against HSV.
- Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
- Primary or acquired immunodeficient states.
- Pregnant or lactating.
- Prior organ transplantation.
- Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
- Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
- History of or current central nervous system metastases.
- History of seizure disorders within 6 months of Screening.
- Active oral or skin herpes lesion at Screening.
- Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids.
- Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.
- History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody. 18\. Active infection with SARS-CoV-2 virus. 21.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Bedford Park, Australia
- Frankston, Australia
- Melbourne, Australia
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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Pittsburgh, Pennsylvania, United States; Dallas, Texas, United States; Fairfax, Virginia, United States; Bedford Park, Australia; Frankston, Australia and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.