Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017
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|ClinicalTrials.gov Identifier: NCT03003468|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2016
Last Update Posted : August 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Imprime PGG Drug: MK-3475||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||A Phase Ib/II Study of Anti-PD-1 Antibody Pembrolizumab and Imprime PGG for Patients With Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017|
|Actual Study Start Date :||February 13, 2017|
|Actual Primary Completion Date :||June 6, 2022|
|Estimated Study Completion Date :||October 2025|
Experimental: Arm A - Phase Ib
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.
Drug: Imprime PGG
Arm A: Phase Ib Cohort 1: 2mg/kg IV; Arm A: Phase Ib Cohort 2: 4mg/kg IV
Drug: Imprime PGG
Arm B: Phase II treatment: administered at the maximum safe dose of 2mg or 4 mg as established in the Phase Ib cohort study.
- Phase Ib: Maximum Tolerated Dose [ Time Frame: From the start of combination treatment until completion of the first cycle of treatment (21 days) ]Phase Ib: Maximum tolerated dose (MTD) for subjects receiving Imprime PGG with pembrolizumab without experiencing dose-limiting toxicity(s) (DLT) per Common Terminology Criteria for Adverse Events (CTCAE) v4.
- Phase II: Progression Free Survival [ Time Frame: 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) ]Progression-free survival (PFS) with Imprime PGG and pembrolizumab combination therapy.
- Assess Adverse Effects [ Time Frame: From start of treatment D1 and every treatment visit thereafter (up to 11 months [16 cycles]) ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability per Common Terminology Criteria for Adverse Events (CTCAE) v4.
- Clinical Benefit Ratio [ Time Frame: From the start of treatment D1 assessed every 6 weeks +/- 1 week while on study treatment (up to 11 months [16 cycles]) ]Clinical Benefit Ratio (complete, partial response, or stable disease) as assessed per RECIST 1.1.
- Progression Free Survival (PFS) at 6 months [ Time Frame: 6 months ]Estimate Progression-Free Survival (PFS) and 6-month PFS using RECIST v1.1 in subjects with NSCLC when treated with Imprime PGG in combination with pembrolizumab who progressed after first-line systemic therapy.
- Overall Survival (OS) [ Time Frame: from the start of the treatment until death from any cause (up to 1 year from start of treatment) ]To determine the overall survival for this patient population at 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003468
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indiana Univeristy Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|University of Iowa Hospital and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Pennsylvania|
|Penn State Cancer Institute|
|Hershey, Pennsylvania, United States, 17033|
|Study Chair:||Lawrence Feldman, M.D.||Big Ten Cancer Research Consortium|