Immunotherapy for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 other cancer medicines. BI 754091 is an immunotherapy. This means it may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. How long the participants are in the study depends on whether they benefit from treatment and whether they experience unacceptable side effects. The participants are put into different groups. Each group receives BI 754091 in combination with another medicine. The doctors check whether the tumors shrink or disappear. The doctors also check the general health of the participants.

Research Team

Eligibility Criteria

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.

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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.

See 9 more

Treatment Details

Interventions

BI 754091 (PD-1 Inhibitor)
BI 754111 (Other)
BI 836880 (Other)

Trial OverviewThe 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.

Participant Groups

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