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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after the last dose of study treatment
Awards & highlights

Study Summary

This trial is testing a combination of two immunotherapy drugs to treat NSCLC that has returned or spread. The drugs may help the immune system attack the cancer and prevent tumor cells from growing and spreading.

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.Check my eligibility
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.See study design
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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You have already tried standard chemotherapy and immunotherapy. You may have had up to 3 previous treatments for your condition.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Disease control rate
Overall objective response rate
Overall survival
+1 more
Other outcome measures
Correlative biomarkers
Levels of myeloidderived suppressor cells (MDSC)

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 2
~1920
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Dwight OwenLead Sponsor
4 Previous Clinical Trials
159 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,805 Total Patients Enrolled
Dwight H OwenPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
84 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05234307 — Phase 1
Lung Cancer Research Study Groups: Treatment (PBF-1129, nivolumab)
Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05234307 — Phase 1
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05234307 — Phase 1

Frequently Asked Questions

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

What is the current size of the patient cohort for this clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this medical experiment is actively searching for potential candidates. This trial was initially posted in November of 2022 and its parameters were last revised 13th October 2022; 30 patients need to be enrolled from a solitary research site."

Answered by AI

Is this research initiative presently searching for participants?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this medical research, which was initially published on November 1st 2022, is still actively recruiting patients. 30 individuals will have to be accepted from a single site in order for the trial to reach completion."

Answered by AI

Has the Adenosine A2B Receptor Antagonist PBF-1129 been granted regulatory clearance?

"PBF-1129, an Adenosine A2B Receptor Antagonist, has limited clinical evidence of safety and efficacy; our team therefore rated it a 1 on the scale from 1 to 3."

Answered by AI
~11 spots leftby Dec 2024