Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02947386 |
Other study ID # |
I 281616 |
Secondary ID |
NCI-2016-01476I |
Status |
Completed |
Phase |
Phase 1
|
First received |
|
Last updated |
|
Start date |
June 29, 2017 |
Est. completion date |
September 8, 2022 |
Study information
Verified date |
October 2023 |
Source |
Roswell Park Cancer Institute |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This phase I/II trial studies the best dose and side effects of nimotuzumab when giving
together with nivolumab and to see how well they work in treating patients with non-small
cell lung cancer that has spread to other places in the body and usually cannot be cured or
controlled with treatment. Monoclonal antibodies, such as nimotuzumab and nivolumab, may
block tumor growth in different ways by targeting certain cells.
Description:
PRIMARY OBJECTIVES:
I. To determine the dose-limiting toxicities (DLT) and estimate the maximum tolerated dose
(MTD) of nimotuzumab combined with nivolumab in the therapy of advanced non-small cell lung
cancer (NSCLC) in order to establish the recommended phase II dose (RP2D). (Phase I)
II. To evaluate the 12 month overall survival of nimotuzumab in combination with nivolumab in
patients with advanced NSCLC. (Phase II)
SECONDARY OBJECTIVES:
I. Examine the safety and tolerability profile of nivolumab in combination with nimotuzumab
in NCSLC . (Phase I)
II. To evaluate the safety and the tolerability of nimotuzumab in combination with nivolumab
using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common
Terminology Criteria for Adverse Events (CTCAE version 4.0). (Phase I)
III. Determine the immune analysis profile of nivolumab in combination with nimotuzumab.
(Phase I)
IV. Examine the efficacy of the study combination utilizing irRECIST guidelines. (Phase I)
V. Overall response rate (ORR) per the immune-related Response Evaluation Criteria in Solid
Tumors irRECIST. (Phase I)
VI. Progression-free survival (PFS) rate at 1 year. (Phase I)
VII. Progression-free survival (PFS). (Phase I)
VIII. Overall survival (OS). (Phase I)
IX. Disease control rate (DCR) and stable disease (SD). (Phase I)
X. To evaluate the safety profile of Nimotuzaumab in combination with Nivolumab in NCSLC
using the CTCAE V. 4.
XI.To evaluate the efficacy of nimotuzumab in combination with nivolumab in patients with
advanced NSCLC compared to historic outcomes of nivolumab alone, as determined by secondary
measures of efficacy, including: overall response rate (ORR) per irRECIST. (Phase II)
XII. To evaluate the efficacy of nimotuzumab in combination with nivolumab in patients with
advanced NSCLC compared to historic outcomes of nivolumab alone, as determined by secondary
measures of efficacy, including: progression-free survival (PFS) rate at 1 year. (Phase II)
XIII. To evaluate the efficacy of nimotuzumab in combination with nivolumab in patients with
advanced NSCLC compared to historic outcomes of nivolumab alone, as determined by secondary
measures of efficacy, including: progression-free survival (PFS). (Phase II)
XIV. To evaluate the efficacy of nimotuzumab in combination with nivolumab in patients with
advanced NSCLC compared to historic outcomes of nivolumab alone, as determined by secondary
measures of efficacy, including: overall survival (OS). (Phase II)
XV. To evaluate the efficacy of nimotuzumab in combination with nivolumab in patients with
advanced NSCLC compared to historic outcomes of nivolumab alone, as determined by secondary
measures of efficacy, including: disease control rate (DCR) and stable disease (SD). (Phase
II)
TERTIARY OBJECTIVES:
I. Examine the relationship of EGFR expression in tissue to PFS, OS, ORR and adverse events
(AE). (Phase I)
II. Examine the relationship of infiltrating CD4+ and CD8+ T cells and other immune and
genetic markers, and their associated PD-1, CD45RA or CD45RO levels; PD-L1 expression within
both neoplastic and non-neoplastic stromal elements of the tumor microenvironment to PFS, OS,
ORR and AE. (Phase I)
III. Comparison of response assessment criteria for a prospective analysis; irRECIST response
assessment; irRC. (Phase I)
IV. Examine the relationship of EGFR expression in tissue to PFS, OS, ORR and AE. (Phase II)
V. Examine the relationship of infiltrating CD4+ and CD8+ T cells and other immune and
genetic markers, and their associated PD-1, CD45RA or CD45RO levels. (Phase II)
VI. Examine the relationship of PD-L1 expression within both neoplastic and non-neoplastic
stromal elements of the tumor microenvironment to PFS, OS, ORR and AE. (Phase II)
VII. Comparison of response assessment criteria for a prospective analysis; irRECIST response
assessment; irRC. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of nimotuzumab followed by a phase II
study.
Patients receive nivolumab intravenously (IV) over 60 minutes and nimotuzumab IV over 60
minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 12
weeks.