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

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.

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)