Studying Patient Preference for Subcutaneous or Intravenous Administration of Nivolumab and Pembrolizumab for the Treatment of Locally Advanced or Advanced/Metastatic Solid Tumors, PSI-Immune Trial

PRIMARY OBJECTIVES:

I. To evaluate patient preference for SC nivolumab or IV nivolumab in patients with locally advanced or advanced/metastatic solid tumors pending initiation of nivolumab monotherapy or nivolumab-based combinations using patient-preference questionnaire (PPQ). (Cohort A-1)

II. To evaluate patient preference for SC pembrolizumab or IV pembrolizumab in patients with locally advanced or advanced/metastatic solid tumors pending initiation of pembrolizumab monotherapy or pembrolizumab-based combinations using patient-preference questionnaire (PPQ). (Cohort A-2)

SECONDARY OBJECTIVES:

I. To evaluate patient-assessed satisfaction with SC nivolumab (or pembrolizumab) versus IV nivolumab (or pembrolizumab) using Therapy Administration Satisfaction Questionnaire (TASQ-IV or TASQ-SC) in patients with locally advanced or advanced/metastatic solid tumors pending initiation of nivolumab (or pembrolizumab) monotherapy or nivolumab- (or pembrolizumab-) based combinations. (Cohort A-1 and A-2)

II. To evaluate health-related quality of life (HRQoL) with SC or IV nivolumab (or pembrolizumab) based on change in symptoms and function from baseline and over time as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) questionnaire in all cohorts. (Cohort A-1, A-2, B-1 and B2)

III. To monitor clinical benefit of nivolumab (or pembrolizumab) as assessed using physician assessed time to next therapy (TTNT) in all cohorts. (Cohort A-1, A-2, B-1 and B-2)

IV. To evaluate incidence of immune-related adverse events (irAEs) that result in a dose hold or delay in patients treated with either SC or IV nivolumab (or pembrolizumab) monotherapy or combinations in all cohorts. (Cohort A-1, A-2, B-1 and B-2)

EXPLORATORY OBJECTIVES:

I. To evaluate healthcare provider (HCP) perception of time, resource use and convenience for administration with nivolumab SC and IV based on HCP responses to the Healthcare Professional Questionnaires (HCPQs) in all cohorts. (Cohort A-1, A-2, B-1 and B-2)

II. To evaluate patient preference for SC versus (vs.) IV nivolumab (or pembrolizumab) (using PPQ) and patient-assessed satisfaction (using TASQ-IV, TASQ-SC) with SC vs. IV nivolumab (or pembrolizumab) in patients who are already on nivolumab (or pembrolizumab) OR are on another immune checkpoint inhibitor (ICI) therapy pending switch to nivolumab- (or pembrolizumab-) based monotherapy or combinations. (Cohort B-1 and B-2)

III. To evaluate pharmacoeconomic parameters (drug preparation time, chair occupancy time) at the patient, network and system level in patients with locally advanced or advanced/metastatic solid tumors treated with SC or IV nivolumab (or pembrolizumab) monotherapy or nivolumab (or pembrolizumab)-based combinations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:

TREATMENT CROSS-OVER PERIOD: Patients receive nivolumab or pembrolizumab SC on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab or pembrolizumab IV on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

TREATMENT CONTINUATION PERIOD: Patients receive nivolumab or pembrolizumab via patient-preferred treatment modality, SC or IV, on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B:

TREATMENT CROSS-OVER PERIOD: Patients receive nivolumab or pembrolizumab IV on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab or pembrolizumab SC on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

TREATMENT CONTINUATION PERIOD: Patients receive nivolumab or pembrolizumab via patient-preferred treatment modality, SC or IV, on day 1 of each cycle. Cycles of nivolumab repeat every 2 or 4 weeks and cycles of pembrolizumab repeat every 3 or 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.