A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN)

New trial tests INBRX-106 with pembrolizumab for advanced head and neck cancer

NCT: NCT06295731 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Inhibrx Biosciences, Inc · Started: 2024-05-14 · Est. Completion: 2029-05

Plain English Summary

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC is a Phase 3 clinical trial sponsored by Inhibrx Biosciences, Inc studying Head and Neck Squamous Cell Carcinoma (HNSCC). This study tests a new combination therapy (INBRX-106 plus pembrolizumab) against a standard treatment (pembrolizumab alone) for advanced head and neck cancer. It is for patients with head and neck squamous cell carcinoma that has returned or spread and has specific markers (PD-L1 CPS ≥20). Participants will receive either the new combination therapy or pembrolizumab alone, assigned randomly. Alternative treatments may include chemotherapy, other immunotherapies, or targeted therapies, depending on prior treatments and disease status. The trial aims to enroll 410 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with head and neck squamous cell carcinoma that has returned or spread and cannot be cured by local treatments. Must have specific PD-L1 protein levels (CPS ≥20) in their tumor. Cannot have certain other head and neck cancers (nasopharynx, salivary glands) or brain metastases. Must be in good general health (ECOG 0 or 1) and not have received certain prior cancer treatments for advanced disease. This trial is studying Head and Neck Squamous Cell Carcinoma (HNSCC), so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how long patients live without their cancer getting worse (Progression-Free Survival) and how long they live overall (Overall Survival), indicating the new combination's p The specific primary outcome measures are: Phase 2: Objective Response Rate (ORR) (up to 6 months); Phase 3: Progression-Free Survival (PFS) (From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)); Phase 3: Overall Survival (OS) (From randomization until death from any cause (up to 4 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for more effective first-line treatments for patients with advanced head and neck cancer, particularly those with high PD-L1 expression, where current options have As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Head and Neck Squamous Cell Carcinoma (HNSCC), where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in head and neck cancer, a market with substantial patient numbers; success could position INBRX-106 as a key player in combination immunotherapy for this a Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, considering your specific cancer type, PD-L1 status, and previous treatments. Participation involves regular study visits for treatment infusions, scans, and tests to monitor your health and cancer. You will be randomly assigned to receive either the new drug combination or the standard drug, and will be closely monitored for side effects. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
* Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
* Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
* Has measurable disease per RECIST 1.1 guidelines.
* Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
* Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.

Exclusion Criteria:

* Has primary tumor site (any histology) of nasopharynx or salivary glands or occult primary site.
* Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for locally advanced unresectable or metastatic HNSCC.

  * Prior systemic therapy completed \>6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy in the locoregionally advanced disease with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
* Has clinically active central nervous system metastases and/or carcinomatous meningitis.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Rapidly progressing disease or with features that may confer a high risk of tumor-associated hemorrhage or uncontrolled tumor pain.
* Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06295731?

NCT06295731 is a Phase 3 INTERVENTIONAL study titled "INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC." It is currently active, not recruiting and is sponsored by Inhibrx Biosciences, Inc. The trial targets enrollment of 410 participants.

What conditions does NCT06295731 study?

This trial investigates treatments for Head and Neck Squamous Cell Carcinoma (HNSCC). The primary condition under study is Head and Neck Squamous Cell Carcinoma (HNSCC).

What treatments are being tested in NCT06295731?

The interventions being studied include: INBRX-106 (DRUG), Pembrolizumab (DRUG). INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)

What does Phase 3 mean for NCT06295731?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06295731?

This trial is currently "Active, Not Recruiting." It started on 2024-05-14. The estimated completion date is 2029-05.

Who is sponsoring NCT06295731?

NCT06295731 is sponsored by Inhibrx Biosciences, Inc. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06295731?

The trial aims to enroll 410 participants. The trial status is active, not recruiting.

How is NCT06295731 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06295731?

The primary outcome measures are: Phase 2: Objective Response Rate (ORR) (up to 6 months); Phase 3: Progression-Free Survival (PFS) (From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)); Phase 3: Overall Survival (OS) (From randomization until death from any cause (up to 4 years)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06295731 being conducted?

This trial is being conducted at 20 sites, including Duarte, California; Los Angeles, California; Sacramento, California; San Diego, California and 16 more sites (United States).

Where can I find official information about NCT06295731?

The official record for NCT06295731 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06295731. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06295731 testing in simple terms?

This study tests a new combination therapy (INBRX-106 plus pembrolizumab) against a standard treatment (pembrolizumab alone) for advanced head and neck cancer. It is for patients with head and neck squamous cell carcinoma that has returned or spread and has specific markers (PD-L1 CPS ≥20).

Why is this trial significant?

This trial addresses a critical need for more effective first-line treatments for patients with advanced head and neck cancer, particularly those with high PD-L1 expression, where current options have As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06295731?

Common side effects may include fatigue, rash, and flu-like symptoms due to the immune system being activated. More serious risks can involve severe immune reactions, inflammation in organs (like lungs, liver, or thyroid), and potential for severe skin reactions. Pembrolizumab can cause immune system reactions where the body attacks healthy organs. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06295731?

Ask your doctor if this trial is right for you, considering your specific cancer type, PD-L1 status, and previous treatments. Participation involves regular study visits for treatment infusions, scans, and tests to monitor your health and cancer. You will be randomly assigned to receive either the new drug combination or the standard drug, and will be closely monitored for side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06295731 signal from an investment perspective?

This trial targets a significant unmet need in head and neck cancer, a market with substantial patient numbers; success could position INBRX-106 as a key player in combination immunotherapy for this a This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either the new combination therapy or pembrolizumab alone, assigned randomly. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.