Your Kidney Cancer Immunotherapy: How You Get It and If Labs Can Be At Home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, phase 4 study from Memorial Sloan Kettering Cancer Center explores patient delivery preferences for immunotherapy (nivolumab and pembrolizumab) in renal cell carcinoma. It also looks at the feasibility of doing labs at home and using telehealth visits prior to treatment days. Eligible participants are those already receiving standard care with specific nivolumab or pembrolizumab regimens and who have enough remaining planned doses to participate. The study is conducted at MSK locations in New Jersey and involves sharing treatment delivery methods and logistical feasibility. Outcomes may inform patient-centered delivery options for immunotherapy in kidney cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Sahil Doshi, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Sahil Doshi, MD
• Email: doshis@mskcc.org
• Phone: 646-422-4341

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.