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PD-L1 Inhibitor

PT-112 for Non-Small Cell Lung Cancer (PAVE-1 Trial)

Phase 1 & 2

Waitlist Available

Led By Daniel D Karp, MD

Research Sponsored by Phosplatin Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

PAVE-1 Trial Summary

This trial is testing a new drug (PT-112) in combination with an existing immunotherapy drug (avelumab) to see if it is safe and effective in treating advanced solid tumors. The trial will be conducted in two parts, with the first part testing different doses of PT-112 to see what is safe and effective, and the second part testing a set dose of PT-112 in patients with non-small cell lung cancer.

Eligible Conditions

Non-Small Cell Lung Cancer

PAVE-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced, squamous or non-squamous NSCLC.

Secondary outcome measures

NSCLC Cohort: Assess the safety profile of PT-112 in combination with avelumab

NSCLC Cohort: Confirm the RP2D patients with metastatic or locally advanced, squamous or non-squamous NSCLC

NSCLC Cohort: Evaluate PFS rate at 6 months from start of study drug, based on tumor assessments every 8 weeks based on iRECIST

+4 more

PAVE-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: PT-112 in combination with avelumabExperimental Treatment2 Interventions

PT-112, administered by intravenous infusion avelumab, administered by intravenous infusion Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

avelumab

2021

Completed Phase 3

~1170

PT-112

2017

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Phosplatin TherapeuticsLead Sponsor

2 Previous Clinical Trials

133 Total Patients Enrolled

Promontory Therapeutics Inc.Lead Sponsor

2 Previous Clinical Trials

133 Total Patients Enrolled

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,958 Total Patients Enrolled

Frequently Asked Questions

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

Are there any additional investigations into the potential of PT-112?

"PT-112 was first trialed in 2014 at the Port Macquarie Base Hospital, with 49 trials having been finished. Currently, 111 studies are underway; many of which can be found within Rochester Minnesota."

Answered by AI

Are there vacancies within this research protocol?

"The research posted on clinicaltrials.gov does not seem to be enrolling patients presently. Originally posted in April 2018, this study was last updated in October 2022; yet, there are an abundance of other medical endeavours actively recruiting individuals at the moment - 1638 trials to be exact."

Answered by AI

Is this an unprecedented clinical trial?

"Research into the potential of PT-112 has been underway since 2014, when EMD Serono Research & Development Institute initiated a clinical trial with 204 participants. After its successful Phase 2 approval, 111 trials are still ongoing throughout 1024 cities and 52 countries."

Answered by AI

What is the projected enrollment for this clinical trial?

"As of the last update on October 27th, 2022, this trial is not currently looking for individuals to participate. However, 1527 trials are actively seeking patients with non-small cell lung carcinoma and 111 studies require participants for PT-112."

Answered by AI

What are the number of venues at which this trial is currently being conducted?

"At the moment, 5 clinical trial sites are accepting participants: Rochester, Houston and Phoenix - plus two other locations. To minimise travel burden when enrolling in this study it may be beneficial to select a nearby medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

2018. "A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03409458.