Combination Immunotherapy + Chemotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+43 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?With an amendment of the protocol, this study is only open to adults with head and neck cancer. Previously also adults with liver cancer joined. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. With the amendment, all new participants also receive cetuximab. Previously participants got additional chemotherapy, no additional medicine, or BI 836880. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

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.

Inclusion Criteria

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

Expected life expectancy of at least 3 months.

I agree to provide required biopsy samples before and during treatment.

+13 more

Exclusion 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 have had severe reactions to antibody treatments before.

+6 more

Participant Groups

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.

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.