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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary endpoint of the trial is objective response (OR), defined as best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator

Secondary outcome measures

Disease control (DC), defined as best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by the Investigator

Duration of response (DoR), defined as the time from first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death among patients with

Progression-free survival (PFS), defined as the time from first treatment until PD or death from any cause, whichever occurs earlier

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

~120

BI 754091

2018

Completed Phase 1

~520

BI 754111

2018

Completed Phase 1

~320

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,499 Previous Clinical Trials

11,339,554 Total Patients Enrolled

Media Library

BI 754091 (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03697304 — Phase 2

Cancer Research Study Groups: Cohort 1 - Module A, Cohort 2 - Module A, Cohort 1 - Module C, Cohort 3 - Module C, Cohort 3 - Module A, Cohort 2 - Module C, Cohort 4 - Module C, Cohort 5 - Module C

Cancer Clinical Trial 2023: BI 754091 Highlights & Side Effects. Trial Name: NCT03697304 — Phase 2

BI 754091 (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03697304 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different health care facilities are participating in this research project?

"This clinical trial is accepting patients at 14 locations including Florida Cancer Specialists in Fort Myers, Florida, Norton Cancer Institute in Louisville, Kentucky, and Tennessee Oncology in Chattanooga, Tennessee."

Answered by AI

Are people with the qualifying condition able to enroll in this research project at this time?

"No, this particular trial is not currently looking for new participants. However, 664 other trials are still open and actively recruiting patients. The original posting date for this trial was March 7th, 2019 with the most recent update on November 14th, 2020."

Answered by AI