A Study of Treatment Delivery Preference In People With Kidney Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to see if people prefer immunotherapy treatment for kidney cancer delivered intravenously or subcutaneously and if it is practical for participants to receive labs at home and have a video (telehealth) visit with their doctor prior to their day of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is receiving standard of care treatment for renal cell carcinoma for one of the following indications: 1) NIVO monotherapy as maintenance, after ipilimumab and NIVO induction (up to 4 doses), 2) NIVO monotherapy as single-agent treatment, OR 3) adjuvant PEMBRO monotherapy or combination therapy with belzutifan. Of note, patient does not need to be newly initiating treatment to be eligible for this study.
For patients on NIVO monotherapy or PEMBRO (Groups 2 and 3 above), they must have received at least 1 dose as a standard of care to be eligible
Patient has at least 6 doses of planned treatment left as standard of care that can be given on protocol (either NIVO or PEMBRO)
For example, standard of care for adjuvant PEMBRO is 1 year of therapy which can be given at 3 (17 doses) or 6 (9 doses) week intervals. Patients can enter this trial after starting treatment but must have at least 6 doses of treatment left to be eligible.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Nivolumab Injectable Product
DrugParticipants will be randomized to receive nivolumab subcutaneously
Nivolumab
DrugParticipants will be randomized to receive Nivolumab intravenously
Pembrolizumab injection
DrugParticipants will be randomized to receive Pembrolizumab subcutaneously
Pembrolizumab
DrugParticipants will be randomized to receive Pembrolizumab intravenously
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBROExperimental treatment 2 interventions
Group B: Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBROExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part I: Participants preference between intravenous/IV vs subcutaneous/SC immune checkpoint inhibitor (NIVO and PEMBRO) for Renal Cell Carcinoma.
The primary outcome is participants preference between the two formulations.
Time frame
1 year2
Part 2: Participant Preference between Standard of Care Delivery vs Labs at Home +Telehealth Visit
The primary outcome is participant preference between the two delivery models.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov