Immunotherapy for Advanced Cancer

No longer recruiting at 24 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Corticosteroids, Anticonvulsants

Disqualifiers: CNS metastases, Autoimmune disease, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new immunotherapy medicine called BI 754091, which may help the immune system fight advanced cancers. The study combines this medicine with other cancer drugs, including BI 754111 and BI 836880, to determine if it can shrink or eliminate tumors and improve overall health. Participants are sorted into groups, each receiving a different combination of treatments. This trial might suit those with advanced cancer that hasn't responded well to previous treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, you cannot have had any investigational anti-tumor treatment within 4 weeks before starting the trial, and you should not be on immunosuppressive corticosteroids above a certain dose. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BI 754091, an immunotherapy, is generally well tolerated. This medicine has demonstrated lasting effects against tumors in various solid cancers, with safety comparable to other immune-boosting cancer treatments.

BI 754111, often used with BI 754091, has been studied in several trials. Together, they have shown a manageable safety profile, typically not causing severe side effects that would halt their use.

BI 836880 is also part of the study. Testing has determined the safest dose for people. This treatment targets the blood vessels tumors need to grow. Previous research has shown it can effectively halt tumor growth.

Overall, past trials have shown that the treatments in this study are tolerable, with side effects usually not severe and manageable. Participants can feel reassured that these treatments have undergone testing in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments BI 754091, BI 754111, and BI 836880 for advanced cancer because they offer innovative approaches compared to traditional therapies like chemotherapy and radiation. BI 754091 and BI 754111 are immune checkpoint inhibitors, which work by targeting proteins that usually keep the immune system in check, thereby allowing the body's immune cells to attack cancer more effectively. BI 836880 is unique because it targets angiogenesis, the process by which tumors develop new blood vessels, effectively starving the tumor by cutting off its blood supply. These treatments not only aim to improve efficacy but also hope to reduce side effects commonly associated with conventional treatments, making them a promising option for patients with advanced cancer.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

In this trial, participants will receive one of the investigational treatments. Studies have shown that BI 754091, an immunotherapy drug, helps the immune system fight cancer by blocking proteins that prevent immune cells from attacking tumors. Research suggests that BI 754091, when combined with other treatments, can shrink tumors and is generally safe. BI 754111, another experimental drug in this trial, complements BI 754091 by targeting different proteins that help tumors evade the immune system. This combination could enhance the immune system’s ability to detect and destroy cancer cells. Lastly, BI 836880, also under investigation in this trial, targets proteins involved in tumor blood vessel growth, potentially slowing tumor growth. Early studies have shown it may reduce tumor size in lab models. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced cancer, including gastric adenocarcinoma, metastatic solid tumors resistant to PD-1/PD-L1 therapy, colorectal cancer, and endometrial carcinoma. Participants must be over 18 years old with an ECOG score of 0 or 1 and a life expectancy of at least 12 weeks. They should have measurable lesions and agree to tumor biopsies. Women who can bear children and men must use effective birth control.

Inclusion Criteria

Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement.

I agree to have tumor biopsies before and during treatment.

My cancer type has been confirmed by a lab test.

Exclusion Criteria

You have had serious allergic reactions to other similar medications or to the drugs being used in the trial.

I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last 4 weeks.

I have an autoimmune disease but it's not vitiligo or resolved childhood asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 754091 in combination with other cancer medicines. The treatment duration depends on the participants' response and side effects.

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 754091
• BI 754111
• BI 836880

Trial Overview The trial is testing BI 754091 combined with other cancer medicines in adults with various advanced cancers. BI 754091 is an immunotherapy designed to boost the immune system's ability to fight cancer. The study will monitor if this combination leads to tumor shrinkage or disappearance while also checking participants' overall health.

How Is the Trial Designed?

Group I: Cohort 5 - Module C Experimental Treatment 2 Interventions

Group II: Cohort 4 - Module C Experimental Treatment 2 Interventions

Group III: Cohort 3 - Module C Experimental Treatment 2 Interventions

Group IV: Cohort 3 - Module A Experimental Treatment 2 Interventions

Group V: Cohort 2 - Module C Experimental Treatment 2 Interventions

Group VI: Cohort 2 - Module A Experimental Treatment 2 Interventions

Group VII: Cohort 1 - Module C Experimental Treatment 2 Interventions

Group VIII: Cohort 1 - Module A Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10981579/

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in ... This manuscript reports data from three open-label, Phase I studies assessing ezabenlimab monotherapy in patients with advanced solid tumours.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.098

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in ... Conclusions: BI 836880 plus ezabenlimab had a manageable safety profile in pts with advanced MSS CRC; however, anti-tumor activity was limited ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03697304?term=AREA%5BConditionSearch%5D(%22Neoplasm%20Metastasis%22)&rank=8

Platform Trial Evaluating Safety and Efficacy of BI 754091 ... This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.3_suppl.2

Ezabenlimab (BI 754091) plus modified docetaxel ... Preliminary results from this ongoing Phase II study show promising antitumor activity and manageable safety of ezabenlimab plus mDCF in pts with Tx-naïve, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03964233?term=NCT03964233&rank=1

NCT03964233 | A Study in Patients With Different Types of ... The participants get a combination of 2 medicines called brigimadlin (also called BI 907828) and ezabenlimab (also called BI 754091). Brigimadlin is a so-called ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03697304

Study Details | NCT03697304 | Platform Trial Evaluating ... The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy. This means it ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38554156/

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in ... Ezabenlimab was well tolerated and associated with durable antitumour activity in multiple solid tumours, comparable to other immune checkpoint inhibitors.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.3063

Safety of BI 754111, an anti-LAG-3 monoclonal antibody ... Here, we report combined safety data from 4 trials investigating BI 754111, an anti-LAG-3 mAb, in combination with BI 754091, an anti-PD-1 mAb, ...