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PD-1 Inhibitor
Immunotherapy for Advanced Cancer
Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient ≥18 years of age at the time of signature of the ICF.
Eastern Cooperative Oncology Group (ECOG) score: 0 or 1.
Must not have
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
Unresolved, Grade >1 toxicity before the start of treatment with the study drug except for hair loss (alopecia) and hypothyroidism that requires thyroid hormone supplements but is asymptomatic under therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new immunotherapy in adults with advanced cancer. The goal is to see if it helps the immune system fight cancer, and if it's well-tolerated. Participants will be in the study for varying lengths of time, depending on how well they respond to treatment and if they experience any side effects.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include typical reactions associated with immunotherapies such as inflammation in different body parts, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders that could affect clotting or immunity levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am using or willing to use effective birth control during and 6 months after the trial.
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My cancer is in the stomach or lower esophagus and has been treated with anti-PD-1 or anti-PD-L1 before.
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My cancer did not respond to previous anti-PD-1/PD-L1 therapy.
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My endometrial cancer is advanced, has returned after treatment, and does not respond well to curative therapy.
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My cancer did not respond to initial PD-1/PD-L1 therapy.
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My cancer is advanced stomach cancer that cannot be surgically removed.
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My cancer worsened after initially responding to PD-1 or PD-L1 therapy.
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My cancer, not lung or skin, worsened after initially responding to PD-1 or PD-L1 therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken high doses of steroids like prednisone (more than 10 mg daily) in the last 4 weeks.
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I don't have any major side effects from previous treatments, except for hair loss or controlled hypothyroidism.
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I have been treated with more than one anti-PD-(L)1 therapy before.
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I haven't had, nor do I plan to have, major surgery around the trial period.
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I have not had severe bleeding or blood clot events in the last year.
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I have been treated with an anti-LAG-3 agent before.
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I haven't taken any experimental cancer treatments recently.
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I do not have serious heart or blood vessel diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 5 - Module CExperimental Treatment2 Interventions
Group II: Cohort 4 - Module CExperimental Treatment2 Interventions
Group III: Cohort 3 - Module CExperimental Treatment2 Interventions
Group IV: Cohort 3 - Module AExperimental Treatment2 Interventions
Group V: Cohort 2 - Module CExperimental Treatment2 Interventions
Group VI: Cohort 2 - Module AExperimental Treatment2 Interventions
Group VII: Cohort 1 - Module CExperimental Treatment2 Interventions
Group VIII: Cohort 1 - Module AExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 836880
2016
Completed Phase 2
~370
BI 754091
2018
Completed Phase 1
~510
BI 754111
2018
Completed Phase 1
~320
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,549 Previous Clinical Trials
15,768,848 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I don't have any major side effects from previous treatments, except for hair loss or controlled hypothyroidism.I have been treated with more than one anti-PD-(L)1 therapy before.I haven't had, nor do I plan to have, major surgery around the trial period.I agree to have tumor biopsies before and during treatment.My cancer type has been confirmed by a lab test.My colorectal cancer is advanced, cannot be surgically removed, and has not responded to at least one other treatment.I have not had 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 am using or willing to use effective birth control during and 6 months after the trial.My cancer is in the stomach or lower esophagus and has been treated with anti-PD-1 or anti-PD-L1 before.My cancer did not respond to previous anti-PD-1/PD-L1 therapy.I am 18 years old or older.I have been treated with an anti-LAG-3 agent before.My endometrial cancer is advanced, has returned after treatment, and does not respond well to curative therapy.I agree to have a biopsy before treatment and another during treatment if needed.My cancer did not respond to initial PD-1/PD-L1 therapy.I haven't taken any experimental cancer treatments recently.I have a genetic tendency to bleed or form blood clots, as confirmed by a doctor.My cancer is advanced stomach cancer that cannot be surgically removed.I do not have serious heart or blood vessel diseases.I have brain metastases but have been treated, symptom-free, and off steroids or seizure meds for 2 weeks.My cancer worsened after initially responding to PD-1 or PD-L1 therapy.My cancer, not lung or skin, worsened after initially responding to PD-1 or PD-L1 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - Module A
- Group 2: Cohort 2 - Module A
- Group 3: Cohort 1 - Module C
- Group 4: Cohort 3 - Module C
- Group 5: Cohort 3 - Module A
- Group 6: Cohort 2 - Module C
- Group 7: Cohort 4 - Module C
- Group 8: Cohort 5 - Module C
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.
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