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Checkpoint Inhibitor

PBF-1129 + Nivolumab for Lung Cancer

Phase 1

Recruiting

Led By Dwight H Owen

Research Sponsored by Dwight Owen

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Confirmed recurrent or metastatic non-small cell carcinoma of the lung of any histology without curative options

Must not have

Has active autoimmune disease, including myasthenic syndrome, which has required systemic treatment in the past 2 years

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after the last dose of study treatment

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing PBF-1129 and nivolumab in patients with advanced lung cancer. The goal is to see if these drugs can work together to stop cancer growth and boost the immune system's ability to fight the cancer. Nivolumab has shown effectiveness in treating various cancers, including non-small cell lung cancer.

Who is the study for?

Adults with recurrent or metastatic non-small cell lung cancer who have tried standard treatments, including chemotherapy and immunotherapy. They must have good organ function, no untreated brain metastases, no active infections like HIV/Hepatitis B or C, not be pregnant/breastfeeding, and willing to use contraception. Prior PD-1/PD-L1 therapy is required; prior CTLA4 therapy is okay.

What is being tested?

The trial tests PBF-1129 combined with nivolumab to determine the safest dose and side effects for treating non-small cell lung cancer that has returned or spread. It explores how these drugs might help the immune system fight cancer by inhibiting tumor growth.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving drugs through a vein, fatigue, possible liver enzyme changes indicating liver damage, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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You have advanced lung cancer that has come back or spread, and there are no options to cure it.

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If you have a specific gene mutation that can be treated with FDA-approved medications, you must have already tried all the standard treatments for that mutation. For example, if you have an EGFR mutation, you should have already tried osimertinib.

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You are able to perform everyday activities without any problem or with a little restriction.

Exclusion Criteria

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

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You have a condition where your immune system attacks your own body and have needed strong treatment for it in the past 2 years.

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You have a weakened immune system or are taking certain medications that weaken your immune system.

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You have a current, ongoing infection with HIV, Hepatitis B, or Hepatitis C.

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You have severe liver cirrhosis or serious complications from cirrhosis such as hepatic encephalopathy or significant fluid buildup in the abdomen.

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You had bad side effects from a previous treatment with a checkpoint inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after the last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after the last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after the last dose of study treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Secondary study objectives

Disease control rate

Overall objective response rate

Overall survival

+1 more

Other study objectives

Correlative biomarkers

Levels of myeloidderived suppressor cells (MDSC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (PBF-1129, nivolumab)Experimental Treatment3 Interventions

Patients receive PBF-1129 PO QD and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Nivolumab

FDA approved

0 / 10Eligibility criteria met