Renal Cell CarcinomaPhase 4NCT07872553
A Study of Treatment Delivery Preference In People With Kidney Cancer
A Phase 4 study testing Nivolumab Injectable Product, Nivolumab and Pembrolizumab injection in people with Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- Nivolumab Injectable Product, Nivolumab and Pembrolizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Sep 2026to 24 Sep 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Sahil Doshi, MD, 646-422-4341
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Sahil Doshi, MD, 646-422-4341
About this study
Official title: Subcutaneous Versus Intravenous Immune Checkpoint Inhibitors, Treatment Burden, and Care Delivery for Patients With Renal Cell Carcinoma
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
- Being tested
- Nivolumab Injectable Product, Nivolumab, Pembrolizumab injection, Pembrolizumab
- Keywords
- Renal Cell Carcinoma, Kidney Cancer, Memorial Sloan Kettering Cancer Center, 26-208
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab Injectable ProductDrug
Participants will be randomized to receive nivolumab subcutaneously
NivolumabDrug
Participants will be randomized to receive Nivolumab intravenously
Pembrolizumab injectionDrug
Participants will be randomized to receive Pembrolizumab subcutaneously
PembrolizumabDrug
Participants will be randomized to receive Pembrolizumab intravenously
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBRO | Experimental | Participants will be randomized to receive IV nivolumab/NIVO or pembrolizumab/PEMBRO Receives: Drug: Nivolumab; Drug: Pembrolizumab |
| Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO | Experimental | Participants will be randomized to receive subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO Receives: Drug: Nivolumab Injectable Product; Drug: Pembrolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start24 Sep 2026
- Primary completion24 Sep 2030 (estimated)
- Study completion24 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sahil Doshi, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872553
- Sponsor's protocol ID
- 26-208
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Versus Intravenous Immune Checkpoint Inhibitors, Treatment Burden, and Care Delivery for Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07872553
- Acronym / sponsor ID
- 26-208
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Keywords
- Renal Cell Carcinoma, Kidney Cancer, Memorial Sloan Kettering Cancer Center, 26-208
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 24 Sep 2030 (estimated)
- Study completion
- 24 Sep 2030 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBRO | Experimental | Drug: Nivolumab, Drug: PembrolizumabParticipants will be randomized to receive IV nivolumab/NIVO or pembrolizumab/PEMBRO |
| Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO | Experimental | Drug: Nivolumab Injectable Product, Drug: Pembrolizumab injectionParticipants will be randomized to receive subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
- Age ≥ 18
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab Injectable ProductParticipants will be randomized to receive nivolumab subcutaneously | Drug | Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO |
| NivolumabParticipants will be randomized to receive Nivolumab intravenously | Drug | Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBRO |
| Pembrolizumab injectionParticipants will be randomized to receive Pembrolizumab subcutaneously | Drug | Participants receiving subcutaneous nivolumab/NIVO or pembrolizumab/PEMBRO |
| PembrolizumabParticipants will be randomized to receive Pembrolizumab intravenously | Drug | Participants receiving IV nivolumab/NIVO or pembrolizumab/PEMBRO |
Primary outcome
Part I: Participants preference between intravenous/IV vs subcutaneous/SC immune checkpoint inhibitor (NIVO and PEMBRO) for Renal Cell Carcinoma.
Time frame: 1 year
The primary outcome is participants preference between the two formulations.
Part 2: Participant Preference between Standard of Care Delivery vs Labs at Home +Telehealth Visit
Time frame: 1 year
The primary outcome is participant preference between the two delivery models.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Renal Cell Carcinoma
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sahil Doshi, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nivolumab Injectable Product, Nivolumab and Pembrolizumab injection in people with Renal Cell Carcinoma and Kidney Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahil Doshi, MD (646-422-4341, doshis@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.