What side effects are associated with this type of intervention?

Common treatments for Oral Squamous Cell Carcinoma (OSCC) include surgery, radiation therapy, and chemotherapy. Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, are also used, particularly in recurrent or metastatic cases. These treatments can cause a range of side effects. Surgery may lead to pain, swelling, and difficulty in speaking or swallowing. Radiation therapy often results in mucositis, xerostomia (dry mouth), and dysphagia. Chemotherapy can cause nausea, fatigue, and neutropenia. Immune checkpoint inhibitors, like those studied in the NGM831 trial, can lead to immune-related adverse events such as dermatitis, colitis, hepatitis, and endocrinopathies. These side effects vary in severity and require careful management.

What prior FDA approvals exist?

For the treatment of Oral Squamous Cell Carcinoma (OSCC), the FDA has approved several immune checkpoint inhibitors. Pembrolizumab, an anti-PD-1 antibody, has been approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), including OSCC, particularly in patients whose tumors express PD-L1. Nivolumab, another anti-PD-1 antibody, has also been approved for similar indications. These therapies work by modulating the immune system to enhance the body's ability to fight cancer. The combination of pembrolizumab with cetuximab, an anti-EGFR antibody, is being investigated for its potential efficacy in treatment-refractory metastatic head and neck cancers, which may include OSCC.

What other types of research exist?

Promising novel alternatives to NGM831 for Oral Squamous Cell Carcinoma patients in 2024 include: 1) Pembrolizumab, an immune checkpoint PD-1 receptor antagonist, especially in combination with other treatments. 2) Nivolumab, another PD-1 inhibitor, which has shown efficacy in recurrent or metastatic HNSCC. 3) Combination therapies involving immune checkpoint inhibitors and other modalities such as vaccines, adoptive T-cell transfer, and immune modulating antibodies. These approaches aim to enhance the immune response and improve treatment outcomes.

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Monoclonal Antibodies

NGM831 + Pembrolizumab for Cancer

Phase 1

Waitlist Available

Research Sponsored by NGM Biopharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy.

Performance status of 0 or 1.

Must not have

Prior treatment targeting ILT3.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called NGM831 alone or with other drugs in patients with advanced or spreading solid tumors. The goal is to see if these treatments can help stop the cancer or help the immune system fight it better. One of the drugs being tested has been widely studied and used in various cancers, showing significant improvements in survival rates and being effective in combination with other treatments.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, including various cancers like lung, breast, and colorectal cancer. Participants should be in good physical condition (performance status of 0 or 1) and have recovered from previous treatments' acute effects. They must also have adequate bone marrow, kidney, and liver function. Those who've had prior treatment targeting ILT3 cannot join.

What is being tested?

The study is testing NGM831 on its own and combined with pembrolizumab to see how well they work against different types of advanced cancers. The goal is to find out if these treatments can help control the growth of cancer cells.

What are the potential side effects?

Potential side effects may include immune-related reactions due to pembrolizumab's action on the immune system; this could lead to inflammation in organs like the lungs or colon. Other common side effects might involve fatigue, skin issues, nausea, and changes in blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread and was confirmed by a lab test.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatments targeting ILT3 before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Number of Patients with Dose-limiting Toxicities

Secondary study objectives

Anti-drug Antibodies (ADA) Against NGM438

Anti-drug Antibodies (ADA) Against NGM831

Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: NGM831 combination dose finding with pembrolizumab (KEYTRUDA®)Experimental Treatment1 Intervention

Part 1b NGM831 plus pembrolizumab (KEYTRUDA®)

Group II: NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®)Experimental Treatment1 Intervention

Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®)

Group III: NGM831 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Part 1a Single Agent Dose Escalation

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Oral Squamous Cell Carcinoma (OSCC) include surgery, radiation therapy, chemotherapy, and increasingly, immune modulation therapies. Immune modulation therapies, such as those involving immune checkpoint inhibitors like pembrolizumab and nivolumab, work by targeting proteins (PD-1/PD-L1) that cancer cells use to evade the immune system. By blocking these proteins, these therapies enhance the body's immune response against cancer cells. This is particularly important for OSCC patients as it offers a treatment option that can potentially improve outcomes in cases where traditional therapies are less effective. Additionally, targeted therapies like cetuximab, which targets the epidermal growth factor receptor (EGFR), are used to inhibit cancer cell growth and proliferation. Understanding these mechanisms helps patients and clinicians make informed decisions about incorporating these advanced therapies into treatment plans.

Molecular genetics of head and neck cancer (Review).