64 Participants Needed

T3011 + Pembrolizumab for Solid Cancers

Recruiting at 8 trial locations
IP
Overseen ByImmVira Pharma Co. LTD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must have stopped any previous anticancer therapy at least 21 days before starting the trial treatment.

What data supports the effectiveness of the drug Pembrolizumab in treating solid cancers?

Pembrolizumab has shown effectiveness in treating various solid tumors, including non-small cell lung cancer and advanced cancers with specific genetic features (MSI-H/dMMR), by helping the immune system attack cancer cells. It is approved for use in certain lung cancers and melanoma, indicating its potential benefit in solid cancers.12345

What safety information is available for the treatment T3011 + Pembrolizumab?

Pembrolizumab, also known as Keytruda, has been associated with some side effects, including pneumonitis (lung inflammation) in 1%-5% of patients and a rare risk of type 1 diabetes in 0.2% of cases. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can affect organs like the lungs, liver, and thyroid.23567

What makes the drug T3011 + Pembrolizumab unique for treating solid cancers?

The combination of T3011 and Pembrolizumab is unique because it combines a novel oncolytic virus (T3011) with a PD-1 inhibitor (Pembrolizumab), potentially enhancing the immune system's ability to attack cancer cells more effectively than using Pembrolizumab alone.238910

Eligibility Criteria

Adults with advanced solid tumors who've had disease progression after standard treatments or are unlikely to benefit from them. They must have a tumor lesion suitable for injection, a life expectancy over 12 weeks, and agree to use contraception. Exclusions include pregnancy, certain allergies, active infections like COVID-19, recent vaccines, immunodeficiencies, organ transplants, some heart conditions.

Inclusion Criteria

I have a tumor that can be injected with treatment according to my doctor.
My organ functions are within normal ranges according to recent tests.
You have a disease that can be measured using a specific set of guidelines.
See 11 more

Exclusion Criteria

I do not have serious heart conditions like heart failure or unstable angina.
I am allergic to certain virus-based therapies or immune system drugs.
I am currently infected with COVID-19.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

T3011 single agent dose escalation in participants with solid tumors using a 3+3 design to evaluate escalating doses

4 weeks

Phase 2a Part 1

Evaluation of safety, tolerability, and preliminary efficacy of T3011 as a single agent in various cohorts

Up to 2 years

Phase 2a Part 2

Evaluation of safety, tolerability, and preliminary efficacy of T3011 in combination with pembrolizumab

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year after last dose

Treatment Details

Interventions

  • Pembrolizumab
  • T3011
Trial OverviewThe trial is testing T3011 alone and combined with pembrolizumab in patients with various advanced cancers. It's an early-phase study assessing safety and initial effectiveness of these treatments administered directly into the tumor (T3011) and intravenously (pembrolizumab).
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Rollover ArmExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
Group II: Phase 2a Part 2 Arm CExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants with NSCLC
Group III: Phase 2a Part 1 Arm BExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with other solid tumors
Group IV: Phase 2a Part 1 Arm AExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with melanoma
Group V: Phase 1Experimental Treatment1 Intervention
T3011 single agent dose escalation in participants with solid tumors

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇪🇺
Approved in European Union as KEYTRUDA for:
  • Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Urothelial carcinoma
  • Colorectal cancer
  • Gastric cancer
  • Hepatocellular carcinoma
  • Renal cell carcinoma
  • Cervical cancer
  • Endometrial carcinoma
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Who Is Running the Clinical Trial?

ImmVira Pharma Co. Ltd

Lead Sponsor

Trials
6
Recruited
530+

Findings from Research

In a study involving 351 patients with advanced noncolorectal MSI-H/dMMR solid tumors, pembrolizumab showed a significant objective response rate (ORR) of 30.8%, indicating its efficacy in this patient population.
The treatment demonstrated a long median duration of response of 47.5 months and manageable safety, with only 11.1% of patients experiencing severe (grade 3-4) treatment-related adverse events, supporting its use in heavily pretreated cancers.
Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study.Maio, M., Ascierto, PA., Manzyuk, L., et al.[2022]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

References

Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028. [2019]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Nivolumab and pembrolizumab: Monoclonal antibodies against programmed cell death-1 (PD-1) that are interchangeable. [2022]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Pembrolizumab monotherapy for non-small cell lung cancer (NSCLC): can patient stratification be improved in the UK Tayside population? A retrospective cohort study. [2023]