Clinical trial NCT02466568: Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
Official title: A Randomized Phase I/II Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Adenocarcinoma of the Lung
Keywords: advanced
metastatic
lung disease
adenocarcinoma
non-small cell lung cancer (NSCLC)
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

Detailed description: This study has two parts and participants may be involved in either Phase I part or Phase II.

Phase I: Investigators plan to enroll participants in cohorts of 6 and monitor side effects over a 21 day period to determine the maximum tolerated dose (MTD) of nivolumab, which will be given in combination with GM.CD40L. This is being done since this study involves a combination of treatments that have not been studied in humans before and to find the best dose for the Phase II part of the study.

Phase II: Investigators plan to compare any clinical benefit in the participants who receive the combination of GM.CD40L vaccine with nivolumab, to participants that receive only nivolumab.

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of advanced/metastatic adenocarcinoma of the lung
* Eastern Cooperative Oncology Group (ECOG) performance status of 0/1
* Chemotherapy naïve or have completed adjuvant chemotherapy for non-small cell lung cancer (NSCLC) \>6 months prior
* Adequate bone marrow, renal and hepatic function
* Must have measurable metastatic disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
* Mandatory archival tissue or willingness to undergo a fresh biopsy
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Symptomatic brain metastasis or uncontrolled central nervous system (CNS) metastasis
* Pregnancy or breast feeding
* Serious uncontrolled medical disorder or active infection that would impair the participant's ability to receive study treatment
* Prior use of a PD1 or PDL1 inhibitor
* Concurrent use of other anticancer approved or investigational agents is not allowed
* Autoimmune disorders
* Prior malignancy in past 2 years
* Systemic steroids at doses greater than 10 mg/day of prednisone or the equivalent
* Any other pre-existing immunodeficiency condition (including known HIV infection)

Primary outcomes:
measure: Phase I: Recommended Phase II Dose
timeFrame: Up to 2 months
measure: Phase II: Objective Response Rate (ORR)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Phase II: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Phase II: Progression-free Survival (PFS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jhanelle Gray, M.D.
role: PRINCIPAL_INVESTIGATOR
References: