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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response (OR)
Secondary outcome measures
Disease control (DC)
Duration of objective response (DOR)
Occurrence of treatment emergent adverse events (AEs)
+1 moreTrial 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
BI 836880
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,529 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any active cancer other than the one for this trial in the last 5 years, except for certain skin cancers or cervical cancer that were treated.I haven't had any severe bleeding or blood clot events in the last year.I am fully active or restricted in physically strenuous activity but can do light work.I agree to provide required biopsy samples before and during treatment.I use a progestogen-only birth control method.I have had severe reactions to antibody treatments before.I have an autoimmune disease but it's either controlled or doesn't need strong medication.I can provide a recent biopsy or an older one if a new one can't be taken.My only sexual partner has had a successful vasectomy.My fallopian tubes are blocked.I am 18 years old or older.I am using a combined hormonal birth control method.I am using effective birth control or practicing abstinence as required.I am a woman who can become pregnant and agree to use effective birth control during and after the trial.I have had a transplant of stem cells or an organ from another person.I have brain metastases but have been stable for at least 28 days without steroids.I carry at least one SIRPα V2 gene variant.My blood test shows I have the V1/V1 SIRPα genotype.I need urgent treatment for a tumor causing severe symptoms or risks.You currently have a birth control device called an intrauterine device (IUD) or an intrauterine hormone-releasing system (IUS).
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B: BI 765063 + ezabenlimab + chemo (invest choice)
- Group 2: Cohort D: BI 765063 + ezabenlimab + BI 836880
- Group 3: Cohort E: BI 765063 + ezabenlimab + BI 836880
- Group 4: Cohort A: BI 765063 + ezabenlimab + cetuximab
- Group 5: Cohort C: BI 765063 + ezabenlimab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are included in this research experiment?
"Affirmative. Clinicaltrials.gov confirms that this research protocol, which was initially posted on February 25th 2022, is currently recruiting participants. Approximately 150 individuals need to be enrolled from 2 hospitals."
Answered by AI
Are there any opportunities to join this clinical research effort at present?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this research protocol, which was initially uploaded to the website on February 25th 2022, is actively recruiting volunteers. A total of 150 participants need to be enrolled from 2 different medical centres."
Answered by AI
What potential risks should people be aware of when using BI 765063?
"Due to the scant amount of existing data regarding BI 765063's safety and effectiveness, our team surmised that it deserved a score of 1 on their risk scale."
Answered by AI
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