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HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4

Clinical trials are studying HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4 in people with head and neck squamous cell carcinoma. These studies aim to see whether adding it to standard treatment can improve outcomes such as response, time without disease worsening, and survival. The main target group is adults with first-line recurrent or metastatic disease and high PD-L1 CPS.

Table of Contents

Trial overview

The source data describe one interventional trial, which means researchers assign the study treatments and follow what happens over time.[1] The study is titled “Phase 2/3 Randomized Study of INBRX-106 Add-on to Pembrolizumab in First-Line PD-L1 CPS ≥20 R/M HNSCC (HexAgon-HN),” and the condition studied is head and neck squamous cell carcinoma.[1]

The trial is investigating HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4 as part of a comparison against placebo when added to pembrolizumab.[1] The brief summary says the study is comparing INBRX-106 plus pembrolizumab versus pembrolizumab for efficacy, meaning how well the treatment works.[1]

Who is being studied

The target population is people with recurrent or metastatic head and neck squamous cell carcinoma.[1] Recurrent means the cancer has come back, and metastatic means it has spread to other parts of the body.

The study also focuses on patients in the first-line setting, which means this is the first treatment used for the current cancer situation.[1] Another key entry requirement in the title is PD-L1 CPS ≥20, which means the study is looking at patients whose tumor-related PD-L1 score is 20 or higher.[1]

Study design and treatment groups

This is a randomized study, so participants are assigned by chance to different treatment groups.[1] Randomization helps make the groups more similar so the results are easier to compare.

The intervention list shows three study-related treatments: commercially available sterile saline solution used as placebo, KEYTRUDA (pembrolizumab), and HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4 listed as INBRX-106.[1] The source also lists INBRX-106 at 0.1 mg/kg by intravenous infusion, which means it is given into a vein.[1]

The study title and summary show that the main comparison is HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4 plus pembrolizumab versus pembrolizumab alone with placebo.[1]

What the trial measures

The main outcome measures are overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).[1] These are standard cancer trial endpoints, meaning the main results the researchers want to measure.

ORR is defined in the source as the proportion of patients with a complete response or partial response on 2 consecutive occasions at least 4 weeks apart, using RECIST v1.1 criteria.[1] A complete response means no visible tumor on scans, while a partial response means the tumor has shrunk but not disappeared.

PFS is the time from randomization to disease progression or death from any cause, whichever happens first.[1] OS is the time from randomization to death from any cause.[1]

Trial status and size

The trial status is listed as Authorised.[1] This means the study has been approved to proceed in the source registry.

The planned enrollment is 410 participants.[1] This number gives an idea of the study size and how many people researchers hope to include.

Trial ID Phase Condition studied Status Enrollment
2024-515538-34-00 Phase 4 Head and Neck Squamous Cell Carcinoma Authorised 410

FAQ

  • What is being studied in these trials? The trials are studying HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4 as an add-on treatment. Researchers are comparing it with placebo together with pembrolizumab to see if outcomes improve.
  • Who may be able to join the study? The target group is people with head and neck squamous cell carcinoma in the first-line setting. The study focuses on recurrent or metastatic disease with PD-L1 CPS of 20 or higher.
  • What phase is the trial? This study is listed as Phase 4. It is also described as a Phase 2/3 randomized study in the title, so the source data uses both labels.
  • What results are the researchers measuring? The main measures are overall response rate, progression-free survival, and overall survival. These show whether tumors shrink, how long the disease stays under control, and how long patients live.
  • How many people are planned for the study? The planned enrollment is 410 people. That means the study aims to include 410 participants in total.

Ongoing Clinical Trials on HUMAN IGG1 HEXAVALENT ANTIBODY AGAINST TNFRSF4

  • Study of INBRX-106 and Pembrolizumab for First-Line Treatment in Patients with Recurrent or Metastatic Head and Neck Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Italy Poland Romania +1

Glossary

  • Head and neck squamous cell carcinoma: A cancer that starts in the flat cells lining the head and neck area, such as the mouth, throat, or nearby tissues.
  • First-line treatment: The first treatment given for a cancer after it is diagnosed or after it comes back.
  • Recurrent disease: Cancer that has returned after treatment.
  • Metastatic disease: Cancer that has spread to other parts of the body.
  • PD-L1 CPS: A lab score used to measure PD-L1 in the tumor and immune cells. In this study, patients need a score of 20 or higher.
  • Randomized study: A study where participants are assigned by chance to different treatment groups.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Pembrolizumab: A cancer treatment used as part of the comparison in this trial.
  • Overall response rate (ORR): The percentage of patients whose tumors shrink enough to count as a complete or partial response.
  • Progression-free survival (PFS): The length of time after randomization before the cancer gets worse or the patient dies.
  • Overall survival (OS): The length of time from randomization until death from any cause.

References

  1. https://clinicaltrials.gov/study/2024-515538-34-00