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Monoclonal Antibodies

Pembrolizumab + Imprime PGG for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Lawrence Feldman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase Ib: Subjects who progressed after first-line platinum-based chemotherapy and who are candidates for second-line therapy
Subjects with stage IV non-small cell lung cancer as defined by American Joint Committee on Cancer (AJCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of enrollment until the criteria for disease progression is met as defined by recist 1.1 or death from any cause, whichever occurs first (up to 1 year from start of treatment)
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves two drugs. The first part of the trial is testing different doses of the drugs to see what works best. The second part of the trial will test the treatment on more people to see if it is effective.

Who is the study for?
Adults with stage IV non-small cell lung cancer who've progressed after first-line therapy can join. They need proper kidney, liver, and blood function, not be on immunosuppressants or have active infections or autoimmune diseases. No recent major surgeries or live vaccines are allowed.Check my eligibility
What is being tested?
The trial is testing a combination of Pembrolizumab (MK-3475) and Imprime PGG in patients whose cancer has worsened despite treatment. It's an open-label study without randomization where everyone gets the same drugs to see how well they work together.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, infusion-related reactions, fatigue, potential worsening of autoimmune conditions, infection risks due to lowered immunity, and allergic responses specific to the drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer worsened after first platinum-based treatment and I need second-line therapy.
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My lung cancer is at stage IV.
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My cancer has worsened after the first treatment, and I am now eligible for a second treatment.
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My blood test shows I have high levels of IgG anti-β-glucan antibody.
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I am a man who can father children and will use birth control.
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My early stage cancer has progressed within the specified time.
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My cancer has an EGFR or ALK mutation and no longer responds to TKI therapy.
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My kidney function is normal as tested within the last 28 days.
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I am not pregnant or breastfeeding and agree to use two forms of birth control.
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My cancer can be measured on scans taken within the last 28 days.
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I am mostly able to do my daily activities.
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My lung cancer is confirmed to be non-small cell type.
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My liver is functioning well, as tested within the last 28 days.
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I am 18 years old or older.
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I am willing and able to follow the study's schedule and procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of enrollment until the criteria for disease progression is met as defined by recist 1.1 or death from any cause, whichever occurs first (up to 1 year from start of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of enrollment until the criteria for disease progression is met as defined by recist 1.1 or death from any cause, whichever occurs first (up to 1 year from start of 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
Phase II: Progression Free Survival
Phase Ib: Maximum Tolerated Dose
Secondary outcome measures
Assess Adverse Effects
Clinical Benefit Ratio
Overall Survival (OS)
+1 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT02086175
20%
Infusion related reaction
8%
Arthralgia
8%
Fatigue
4%
Chills
4%
Diarrhea
4%
Dry mouth
4%
Otitis externa
4%
Alkaline phosphatase increased
4%
Aspartate aminotransferase increased
4%
Neutrophil count decreased
4%
Hyponatremia
4%
Peripheral sensory neuropathy
4%
Cough
4%
Dyspnea
4%
Alanine aminotransferase increased
4%
Musculoskeletal and connective tissue disorder - Other, specify
4%
White blood cell decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG and Rituximab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm A - Phase IbExperimental Treatment2 Interventions
Dose Escalation Cohort Cohort 1 will consist of 3-6 patients who will receive pembrolizumab 200mg IV on Day 1 of each 21 day cycle. Imprime PGG will be administered at 2mg/kg on Day 1,8, and 15 of cycles 1-4, and on Day 1 of cycles 5-16. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab. Experimental: Arm A - Phase II Investigational Treatment The maximum safe dose of Imprime PGG in combination with pembrolizumab (as determined in the phase Ib cohort) will be given on Day 1,8, and 15 for cycles 1-4, and on Day 1 of cycles 5-16. Cohort 2 will consist of 3-6 patients who will receive pembrolizumab 200mg IV on Day 1 and Imprime PGG at 4mg/kg on Day 1,8, and 15 for Cycles 1-4 and on Day 1 only for Cycles 5-16. On Day 1 of each cycle, the Imprime PGG intravenous infusion is given first followed 15-30 minutes later by the pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imprime PGG
2014
Completed Phase 2
~160
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Lawrence Feldman, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,665 Total Patients Enrolled
HiberCell, Inc.Industry Sponsor
19 Previous Clinical Trials
885 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03003468 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Arm A - Phase Ib
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03003468 — Phase 1 & 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03003468 — Phase 1 & 2

Frequently Asked Questions

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

Has Imprime PGG previously been subject to any other clinical investigations?

"Currently, Imprime PGG has 961 active clinical trials with 122 of them in Phase 3. The majority are situated around Houston, Texas but there is a global reach encompassing 35,731 research sites."

Answered by AI

What are the usual indications for Imprime PGG?

"Imprime PGG is typically prescribed to combat neoplasms, however it has also been shown to be an effective treatment for many other medical conditions such as unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

How many participants have been approved for this clinical experiment?

"Unfortunately, this clinical trial has ceased its participant recruitment process. Initially posted on February 13th 2017 and last updated October 6th 2022; there are still many other studies seeking individuals with non-small cell lung carcinoma (nsclc) - 2045 trials to be exact - as well as 961 for Imprime PGG."

Answered by AI

In what capacity is this clinical trial being conducted in the United States?

"As part of this trial, patients are being enrolled at the University of Iowa Hospital and Clinics in Iowa City, Indiana Univeristy Melvin and Bren Simon Cancer Center in Indianapolis, as well as Rutgers Cancer Institute of New jersey in New Brunswick. Additionally, there are 3 more sites taking part."

Answered by AI

Is this study currently recruiting new participants?

"This trial, which was first posted on 13th February 2017 and last updated 6th October 2022, is not presently recruiting patients. However, there are 3.006 other trials that have current openings for potential participants."

Answered by AI

What are the key goals of this medical research experiment?

"The primary endpoint of this clinical trial, lasting twenty-one days from the onset of combination treatment until its completion, is Progression Free Survival (PFS). Secondary outcomes evaluated include 6 month PFS using RECIST v1.1 in patients with NSCLC treated with Imprime PGG alongside pembrolizumab after being unresponsive to first line treatments; Adverse Events measured through CTCAE v4 and Clinical Benefit Ratio assessed per RECIST 1.1."

Answered by AI
~4 spots leftby Mar 2025