INBRX-106 + Pembrolizumab for Head and Neck Cancer
(HexAgon-HN 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?
Research Team
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INBRX-106 combined with pembrolizumab or pembrolizumab with placebo, administered by IV infusion every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- INBRX-106
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inhibrx Biosciences, Inc
Lead Sponsor
Inhibrx, Inc.
Lead Sponsor