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Checkpoint Inhibitor

Combination Immunotherapy + Chemotherapy for Head and Neck Cancer

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

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 or 1 at the screening visit.

Patients homozygous for V1 allele (including V1-like alleles) of Singal Regulatory Protein-alpha (SIRPα) (V1/V1 SIRPα genotype). SIRPα polymorphism will be assessed in blood sampling (using patient Deoxyribonucleic Acid [DNA]) during Screening 1 Visit.

Must not have

Patients with at least one SIRPα V2 allele, i.e. SIRPα V1/V2 or V2/V2 individuals.

Prior allogeneic stem cell or solid organ transplantation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is for adults with head and neck cancer or liver cancer who haven't responded to previous treatment or for whom no standard treatment exists. The goal is to see if combining different drugs can shrink tumors. The drugs being tested are antibodies that work in different ways against cancer. All participants will receive BI 765063 and ezabenlimab. One group will not receive any additional drugs while the other groups will receive BI 836880, cetuximab, or chemotherapy. The trial will monitor the size of the tumor and the health of the participants.

Who is the study for?

Adults with head and neck or liver cancer, for whom previous treatments failed or no standard treatment is available. Participants must be over 18, have a life expectancy of at least 3 months, and able to perform daily activities with little assistance (ECOG status 0-1). They should not have other active cancers or severe autoimmune diseases requiring systemic treatment. Women who can bear children must use effective contraception.

What is being tested?

The trial tests combinations of BI 765063, Ezabenlimab (both immune system boosters), Cetuximab (growth signal blocker), BI 836880 (blocks blood vessel formation in tumors), and chemotherapy. Patients receive infusions every few weeks and are monitored for tumor shrinkage while assessing the tolerability of the treatments.

What are the potential side effects?

Potential side effects include reactions related to the immune system's increased activity against cancer cells which may affect organs, infusion-related reactions similar to allergic responses, fatigue from energy depletion, digestive issues like nausea or diarrhea, blood disorders affecting cell counts leading to anemia or infection risk.

Eligibility Criteria

Inclusion Criteria

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

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

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My blood test shows I have the V1/V1 SIRPα genotype.

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I am using a combined hormonal birth control method.

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I use a progestogen-only birth control method.

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My fallopian tubes are blocked.

Exclusion Criteria

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

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I carry at least one SIRPα V2 gene variant.

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I have had a transplant of stem cells or an organ from another person.

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I need urgent treatment for a tumor causing severe symptoms or risks.

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I have had severe reactions to antibody treatments before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Objective Response (OR)

Secondary study objectives

Disease control (DC)

Duration of objective response (DOR)

Occurrence of treatment emergent adverse events (AEs)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort E: BI 765063 + ezabenlimab + BI 836880Experimental Treatment3 Interventions

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 2nd line HCC who progressed on therapy with atezolizumab in combination with bevacizumab.

Group II: Cohort D: BI 765063 + ezabenlimab + BI 836880Experimental Treatment3 Interventions

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line HCC.

Group III: Cohort C: BI 765063 + ezabenlimabExperimental Treatment2 Interventions

30 SIRPα V1/V1 homozygous patients with advanced or metastatic 1st line Hepatocellular Carcinoma (HCC).

Group IV: Cohort B: BI 765063 + ezabenlimab + chemo (invest choice)Experimental Treatment3 Interventions

30 SIRPα V1/V1 homozygous patients with 2nd line recurrent/metastatic HNSCC who had received prior platinum-based therapy within the recurrent/metastatic setting.

Group V: Cohort A: BI 765063 + ezabenlimab + cetuximabExperimental Treatment3 Interventions

30 Signal Regulatory Protein Alpha (SIRPα) V1/V1 homozygous patients with 2nd line recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who had received prior platinum-based therapy within the recurrent/metastatic setting.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 765063

2020

Completed Phase 1

~20

Cetuximab

2011

Completed Phase 3

~2480