410 Participants Needed

INBRX-106 + Pembrolizumab for Head and Neck Cancer

(HexAgon-HN Trial)

Recruiting at 39 trial locations
SD
Overseen ByStudy Director - Inhibrx
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, if you are on systemic steroid therapy or any other form of immunosuppressive therapy, you must stop it at least 7 days before the first dose of the study treatment.

What data supports the idea that INBRX-106 + Pembrolizumab for Head and Neck Cancer is an effective treatment?

The available research shows that Pembrolizumab, when used for head and neck cancer, has been approved by the FDA due to its effectiveness in patients who have not responded to other treatments. In a study, 16% of patients showed a positive response, with some experiencing benefits for over six months. This suggests that Pembrolizumab, a part of the INBRX-106 + Pembrolizumab combination, can be effective for treating head and neck cancer, especially when other treatments have failed.12345

What safety data is available for the treatment of INBRX-106 + Pembrolizumab for head and neck cancer?

Safety data for pembrolizumab (KEYTRUDA) in head and neck cancer shows that it was evaluated in 192 patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Serious adverse reactions occurring in 2% or more of patients included pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. Clinically significant immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, adrenal insufficiency, diabetes mellitus, skin toxicity, myositis, and thyroid disorders. The benefit-risk profile was considered acceptable. There is no specific safety data available for INBRX-106 in combination with pembrolizumab in the provided research.12678

Is the drug INBRX-106 and Pembrolizumab a promising treatment for head and neck cancer?

Yes, the drug INBRX-106 and Pembrolizumab is promising for head and neck cancer because Pembrolizumab has shown strong activity in treating this type of cancer, especially in cases where other treatments have failed. It works by helping the immune system fight cancer cells more effectively.146910

Research Team

CL

Clinical Lead

Principal Investigator

Inhibrx Biosciences, Inc

Eligibility Criteria

This trial is for adults with a specific type of head and neck cancer (HNSCC) that can't be cured by surgery or radiation. They must have high levels of a protein called PD-L1, not been treated before, and their cancer should be measurable by scans. Participants need to be fairly healthy overall (good performance status), able to provide tissue samples, and if they can have children, they must use effective birth control.

Inclusion Criteria

Has your cancer spread from your head/neck to other body parts?
Has your cancer been treated "since" it spread to other body parts?
Was your last treatment at least 6 months ago?
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INBRX-106 combined with pembrolizumab or pembrolizumab with placebo, administered by IV infusion every 3 weeks

up to 2 years
Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 4 years

Treatment Details

Interventions

  • INBRX-106
  • Pembrolizumab
Trial Overview The study is testing INBRX-106 combined with Pembrolizumab against just Pembrolizumab in patients with advanced head and neck cancer expressing high PD-L1 levels. It's designed to see which treatment works better as the first line of attack without previous treatments.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: INBRX-106 plus pembrolizumabExperimental Treatment2 Interventions
Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
Group II: pembrolizumab monotherapy (+ placebo in phase 3 part)Active Control2 Interventions
Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Inhibrx Biosciences, Inc

Lead Sponsor

Trials
9
Recruited
1,700+

Inhibrx, Inc.

Lead Sponsor

Trials
9
Recruited
1,700+

Findings from Research

Pembrolizumab, an immune checkpoint inhibitor, has been approved by the FDA for treating platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), offering a new option with potentially improved efficacy compared to traditional chemotherapy and EGFR inhibitors.
This review discusses the pharmacology and tolerability of pembrolizumab, emphasizing its mechanism of action by blocking the PD-1 receptor, which may enhance the immune response against HNSCC tumors.
Pembrolizumab and its use in the treatment of recurrent or metastatic head and neck cancer.Sheth, S., Weiss, J.[2019]
Pembrolizumab (KEYTRUDA) received accelerated FDA approval for treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) based on a study of 174 patients, showing an objective response rate of 16% and a duration of response ranging from 2.4 to 27.7 months.
The safety profile included serious adverse reactions such as pneumonia and respiratory failure, but the overall benefit-risk assessment was deemed acceptable, marking pembrolizumab as the first new treatment option for HNSCC since 2006.
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.Larkins, E., Blumenthal, GM., Yuan, W., et al.[2019]
In a study of platinum-sensitive recurrent or metastatic head and neck squamous cell carcinomas involving 36 patients, both nivolumab and pembrolizumab showed effectiveness, with median overall survival of 16.9 months for nivolumab and 19.2 months for pembrolizumab, indicating similar efficacy between the two treatments.
The median progression-free survival was 4.8 months for nivolumab and 9.3 months for pembrolizumab, with objective response rates of 38% and 47%, respectively, suggesting that both drugs are viable options for treatment in this patient population.
Efficacy of Nivolumab and Pembrolizumab in Platinum-sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.Yamashita, G., Okamoto, I., Ito, T., et al.[2023]

References

Pembrolizumab and its use in the treatment of recurrent or metastatic head and neck cancer. [2019]
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy. [2019]
Efficacy of Nivolumab and Pembrolizumab in Platinum-sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. [2023]
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. [2021]
Programmed Death Ligand-1 Combined Positive Score Concordance and Interrater Reliability in Primary Tumors and Synchronous Lymph Node Metastases in Resected Cases of p16+ Oropharyngeal Squamous Cell Carcinoma. [2023]
Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. [2021]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Effects of Pembrolizumab in Recurrent/Metastatic Squamous Cell Head and Neck Carcinoma: A Multicenter Retrospective Study. [2023]
Cytokine Profiles of Head and Neck Squamous Cell Carcinoma Undergoing Dual Immunotherapy With Cetuximab and Pembrolizumab Identify Interferon Gamma-Induced Protein 10 as Novel Biomarker. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study. [2022]