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PD-L1 Inhibitor

Trabedersen + Pembrolizumab for Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Omar Abughanimeh, MBBS

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 19 years

Metastatic disease or disease not amenable for curative intent therapy

Must not have

Known hypersensitivity to any of the excipients of OT101 or pembrolizumab

Pregnant or breast-feeding women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of combining the drugs OT-101/Trabedersen and Pembrolizumab in adults with certain types of Non-Small Cell Lung Cancer.

Who is the study for?

This trial is for adults with a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that tests positive for PD-L1. Participants will need to visit the clinic regularly for treatment infusions.

What is being tested?

The trial is testing the safety and optimal dose of Trabedersen when used with Pembrolizumab, as well as how effective this combination is in delaying or preventing the worsening of NSCLC.

What are the potential side effects?

Possible side effects from Trabedersen and Pembrolizumab may include reactions at the infusion site, fatigue, immune-related issues affecting organs, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 years old or older.

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My cancer has spread and cannot be cured with surgery or radiation.

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My lung cancer is confirmed and has a PD-L1 level of 1% or higher.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to ingredients in OT101 or pembrolizumab.

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I am not pregnant or breastfeeding.

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I have an immune system disorder or take high-dose steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Dose Finding

Phase II: Progression-Free Survival (PFS)

Secondary study objectives

Best Overall Response

Disease Control

Drug Toxicity

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II: TreatmentExperimental Treatment2 Interventions

Subjects receive the recommended phase II dose of intravenous OT-101/Trabedersen (140, 190, or 250 mg/m2) until progression using a 4 days on 10 days off dosing schedule. Subjects receive concurrent administration of 400 mg intravenous Pembrolizumab every 6 weeks.

Group II: Arm I: Dose FindingExperimental Treatment2 Interventions

Subjects receive either 140, 190, or 250 mg/m2 intravenous OT-101/Trabedersen for up to 12 weeks using a 4 days on 10 days off dosing schedule. The dose level is determined according to the Bayesian optimal interval (BOIN) design with cohort size 3. Subjects receive concurrent administration of 400 mg intravenous Pembrolizumab every 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 7Eligibility criteria met