Recruiting
Early Phase 1

Immunotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07872553

Conditions

Renal Cell Carcinoma

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab Injectable Product

Nivolumab

Pembrolizumab injection

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Renal Cell Carcinoma

Kidney Cancer

Study ID

NCT07872553

Start date

Sep 24, 2026

Status verified date

Oct, 2026

Completion date

Sep 24, 2030

Anticipated

Primary completion date

Sep 24, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients:

A patient cannot be considered eligible for this study unless ALL of the following conditions are met.

  • 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.
  • For example, standard of care for maintenance NIVO (after ipilimumab + NIVO) is typically about 2 years of therapy. NIVO can be given at 2 (about 52 doses) or 4 week (about 26 doses) intervals.
  • Age ≥ 18
  • Ability to speak and read English because we do not have the resources to translate all materials into other languages
  • Patient must be able to provide written informed consent, or a legal authorized representative (LAR)/caregiver must be identified to provide consent in cases where the patient cannot.
  • Patients are unable to receive investigational agents on other clinical trial protocols

Providers (Medical Oncologists):

  • Medical oncologists in the genitourinary medical oncology department will be involved with this study if they are the treating investigator for patients who consent to this study
  • The medical oncologists who are involved in this will be asked to complete surveys

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBRO

Participants will be randomized to receive IV nivolumab/NIVO or pembrolizumab/PEMBRO

experimental: Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO

Participants will be randomized to receive subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO

Interventions

Nivolumab Injectable Product

Participants will be randomized to receive nivolumab subcutaneously

Nivolumab

Participants will be randomized to receive Nivolumab intravenously

Pembrolizumab injection

Participants will be randomized to receive Pembrolizumab subcutaneously

Pembrolizumab

Participants will be randomized to receive Pembrolizumab intravenously

Primary outcome measure

  • Part I: Participants preference between intravenous/IV vs subcutaneous/SC immune checkpoint inhibitor (NIVO and PEMBRO) for Renal Cell Carcinoma. [ Time Frame: 1 year ]
  • Part 2: Participant Preference between Standard of Care Delivery vs Labs at Home +Telehealth Visit [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sahil Doshi, MD

646-422-4341doshis@mskcc.org

Thomas Atkinson, PhD

646-888-0089atkinsot@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Sahil Doshi, MD

646-422-4341

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Sahil Doshi, MD

646-422-4341

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Renal Cell Carcinoma
  • Kidney Cancer
  • Memorial Sloan Kettering Cancer Center
  • 26-208

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.