An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung

Phase 1b: Duration of Objective Response (DOR)

Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause. RECIST for PD - sum of diameters had increased by \>= 20% and \>=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease \[SD\]/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)

Number of participants with PFS event (progressed or died before progression) were reported. PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first. RECIST for PD - sum of diameters had increased by \>= 20% and \>=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR). Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)

Number of participants with OS event (died) were reported. Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Positive Blood Culture

Number of participants with surveillance cultures positive for listeriosis were reported.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Bacterial Shedding

Number of participants with bacterial shedding were reported. The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva.

Time frame: Up to 6.8 months

Phase 1b: Serum Concentrations of Nivolumab

Nivolumab serum concentrations were reported.

Time frame: Up to 6.8 months

Phase 1b: Number of Participants With Anti-nivolumab Antibodies

Number of participants with antibodies to nivolumab were reported.

Time frame: Up to 6.8 months