What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) involving immune checkpoint inhibitors like Pembrolizumab (PD-1 inhibition) can lead to a range of immune-related adverse events. These include skin reactions such as rash and pruritus, gastrointestinal issues like diarrhea, and more severe conditions such as pneumonitis and colitis. Endocrine disorders, including hypothyroidism and adrenal insufficiency, are also observed. Additionally, combination therapies with other agents may increase the incidence of severe adverse events, including infusion-related reactions, severe skin reactions, and sepsis. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), either as a monotherapy or in combination with chemotherapy, based on the KEYNOTE-048 trial. This trial demonstrated improved overall survival compared to cetuximab plus chemotherapy. Cetuximab, an EGFR inhibitor, is another FDA-approved treatment for HNSCC, often used in combination with chemotherapy. These approvals highlight the role of immune checkpoint inhibitors and targeted therapies in managing advanced HNSCC.

What other types of research exist?

Promising novel alternatives for HNSCC treatment include Nivolumab (another PD-1 inhibitor) and combination therapies involving immune checkpoint inhibitors such as Durvalumab (PD-L1 inhibitor) and Tremelimumab (CTLA-4 inhibitor). These agents have demonstrated durable improvements in patient outcomes and are being actively explored in clinical trials.

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PD-L1 Inhibitor

Bapotulimab + Pembrolizumab for Head and Neck Cancer

Phase 1

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Expansion of Bapotulimab in combination with pembrolizumab in Head and neck squamous cell carcinoma (HNSCC): recurrent or metastatic head and neck squamous cell carcinoma IO-naïve PDL1+/ CPS≥1(PD-L1: Programmed death ligand 1; CPS: Combined positive score)

Must not have

Previous or active myocarditis/myositis in history (independent of cause)

Severe (CTCAE v.5.0 Grade ≥ 3) infections within 4 weeks before the first study drug administration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. Clinically active infections (CTCAE v.5.0 > Grade 1) within 2 weeks before the first study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 58 months

Awards & highlights

Summary

This trial is testing a new drug called Bapotulimab combined with Pembrolizumab to see if it is safe and effective for people with recurrent or metastatic Head and Neck Cancer. The goal is to find the best dose and observe how well it works in shrinking tumors.

Who is the study for?

This trial is for adults with head and neck cancer that has returned or spread, expressing a protein called PDL1. Participants must be at least 18 years old, have good heart function, and an ECOG performance status of 0 to 1 (which means they are fully active or restricted in physically strenuous activity but can do light work). They should not have had severe immune side effects from previous immunotherapy, no autoimmune diseases, HIV, hepatitis B/C infections, recent serious infections or myocarditis/myositis history.

What is being tested?

The study tests a new drug named Bapotulimab in combination with Pembrolizumab on patients with recurrent or metastatic Head and Neck Cancer. It aims to determine the safety of this combo treatment, its effects on the body, find the best dose for Bapotulimab and assess how well it works against tumors.

What are the potential side effects?

Potential side effects may include immune-related reactions due to both drugs' action on the immune system which could lead to inflammation in various organs. There might also be infusion-related reactions alongside common issues like fatigue and digestive disturbances.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out all my daily activities without help.

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My head and neck cancer is spreading, hasn't had immunotherapy, and tests positive for PD-L1.

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I have a tumor that can be measured on a scan and it's advanced or has spread.

Exclusion Criteria

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

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I have had or currently have inflammation of the heart or muscles.

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I have not had a severe infection or been hospitalized for one in the last 4 weeks.

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I am HIV positive.

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I have an active hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 58 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 58 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 58 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

AUC of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

Cmax of Bapotulimab after first dose administration (Cycle 1) for cohorts receiving doses ≥ 20 mg

Secondary study objectives

AUC after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg

Best overall response rate

Cmax,md after multiple dosing (Cycle 3) for cohorts receiving doses ≥ 20 mg

Trial Design

3Treatment groups

Experimental Treatment

Group I: Expansion HNSCC_Combination therapyExperimental Treatment1 Intervention

Patients with head and neck squamous cell carcinoma (HNSCC)

Group II: Dose escalation_MonotherapyExperimental Treatment1 Intervention

Patients with solid tumor types considered immunosensitive

Group III: Dose escalation_Combination therapyExperimental Treatment1 Intervention

Patients with solid tumor types considered immunosensitive

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

2018

Completed Phase 1

~60

Bapotulimab (BAY1905254)

2018

Completed Phase 1

~60

0 / 7Eligibility 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

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include immune checkpoint inhibitors like Pembrolizumab and targeted therapies such as Cetuximab. Pembrolizumab inhibits the PD-1 receptor, enhancing the immune system's ability to detect and destroy cancer cells, which is crucial as HNSCC tumors often evade immune detection. Cetuximab targets the EGFR, inhibiting tumor growth and proliferation. These mechanisms are significant for HNSCC patients as they offer a multi-faceted approach to combat the cancer, potentially improving treatment outcomes.

Targeted Therapy in Head and Neck Cancer: An Update on Current Clinical Developments in Epidermal Growth Factor Receptor-Targeted Therapy and Immunotherapies.Update on Head and Neck Cancer: Current Knowledge on Epidemiology, Risk Factors, Molecular Features and Novel Therapies.