Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung

NCT ID: NCT02466568

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2020-07-31

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.

Conditions

Lung Cancer; Adenocarcinoma of the Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I and Phase II Treatment Arm

Participants will receive nivolumab and GM.CD40L. Treatment will be administered on an outpatient basis. The nivolumab will be given first followed by the GM.CD40L vaccine for those enrolled on this arm.

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.

GM.CD40L Vaccine

Intervention Type: BIOLOGICAL

GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.

Phase II Control Arm

Nivolumab treatment without GM.CD40L. Nivolumab will be given every 2 weeks at a dose of 3mg/kg.

Group Type: ACTIVE_COMPARATOR

Nivolumab

Intervention Type: DRUG

Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.

Interventions

Nivolumab

Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.

Intervention Type: DRUG

GM.CD40L Vaccine

GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.

Intervention Type: BIOLOGICAL

Other Intervention Names

Opdivo; Anti-PD-1; Immunotherapy; Cell Vaccine

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jhanelle Gray, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Other Identifiers

1504-1392

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-18147

Identifier Type: -

Identifier Source: org_study_id