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A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
NCT04958239 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Ezabenlimab
- DRUG BI 765179
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc — Brussels
- Edegem - UNIV UZ Antwerpen — Edegem
- AZ Groeninge — Kortrijk
- ICESP - Instituto do Cancer do Estado de Sao Paulo — São Paulo
- Hospital Sírio Libanês-São Paulo-68088 — São Paulo
- Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência — São Paulo
- The First Affiliated Hospital Of Bengbu Medical College — Bengbu
- Hunan Province Tumor Hospital — Changsha
- Fujian Cancer Hospital — Fuzhou
- Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou
- Wuhan Union Hospital — Wuhan
New South Wales
- Border Cancer Hospital — Albury
- Kinghorn Cancer Centre — Darlinghurst
Arizona
- University of Arizona — Tucson
California
- Beverly Hills Cancer Center — Beverly Hills
North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill
South Dakota
- Avera Cancer Institute — Sioux Falls
Texas
- NEXT Oncology-San Antonio-65273 — San Antonio
Queensland
- Townsville Hospital — Douglas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2028-02-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04958239
The ClinicalTrials.gov registry entry for NCT04958239 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04958239 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, New South Wales, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04958239 about?
NCT04958239 is a clinical study titled "A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer". This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or togethe...
What is the current status of trial NCT04958239?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2021-10-18. Estimated completion is 2028-02-17.
What conditions does trial NCT04958239 study?
This clinical trial studies the following conditions: Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04958239?
The interventions under investigation include: Pembrolizumab (DRUG), Ezabenlimab (DRUG), BI 765179 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04958239?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04958239 being conducted?
This trial has 20 study locations across Arizona, California, North Carolina, South Dakota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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