BI 770371 + Pembrolizumab ± Cetuximab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+54 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?

This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing. Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site. Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Adults with head and neck cancer are eligible for this trial. Participants must have a type of cancer that responds to the study medicines. They should be able to receive infusions and commit to regular health checks and tumor assessments.

Inclusion Criteria

I can safely receive cetuximab treatment according to local guidelines.

Presence of at least one measurable non-Central nervous system (CNS) lesion (according to RECIST v1.1)

Willingness to provide pretreatment (baseline) biopsy / tissue to the sponsor (fresh or archival one). A recent biopsy (<3 months) is preferred, however an archival biopsy up to 12 months prior to screening could be accepted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and Sponsor

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Exclusion Criteria

I have had a stem cell or organ transplant.

My cancer is in the nasal area or nearby and its origin is unknown.

My doctor prefers chemotherapy or a combo treatment over pembrolizumab for me.

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Treatment Details

Interventions

BI 770371 (Monoclonal Antibodies)
Cetuximab (Monoclonal Antibodies)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe trial is testing if combining BI 770371 with Pembrolizumab, with or without Cetuximab, is more effective than Pembrolizumab alone in shrinking tumors. Patients will be randomly assigned into three groups to receive different medicine combinations via vein infusion.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Pembrolizumab + BI 770371 + CetuximabExperimental Treatment3 Interventions

Group II: Pembrolizumab + BI 770371Experimental Treatment2 Interventions

Group III: PembrolizumabExperimental Treatment1 Intervention