Kidney CancerNCT07646847
A Study of a Side Effects and Resource Navigation Program for People With Cancer
A study testing Immunotherapy CARE Program in people with Kidney Cancer and Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Bladder Cancer, Breast Cancer
- What is being tested?
- Immunotherapy CARE Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 9 Jun 2026to 9 Jun 2029
- Phase
- Interventional
- 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
- Documentation of Disease
- o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)
- Prior Treatment
- o Within three weeks (+/- 3 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)
- Age ≥ 18 (per EMR)
- Not Pregnant and Not Nursing (per self-report)
Show all 11Show fewer
- At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)
- Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)
- Can speak English or Spanish (per self-report)
- Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)
- Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, or study team)
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Francesca Gany, MD, MS, 646-888-8054
- Not yet recruiting
City College of New York (Data Collection AND Specimen Analysis)
New York, New York, 10031
Bao Vuong, PhD, 212-650-8563, bvuong@ccny.cuny.edu
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Francesca Gany, MD, MS, 646-888-8054
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Francesca Gany, MD, MS, 646-888-8054
About this study
Official title: I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation
The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.
- Conditions
- Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer
- Being tested
- Immunotherapy CARE Program
- Keywords
- Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer, Memorial Sloan Kettering Cancer Center, 25-338
- Medical subject headings
- Kidney Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy CARE ProgramOther
Also called I CARE
For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation
| Study group | Role | What they receive |
|---|---|---|
| I CARE Group | Experimental | Immunotherapy CARE Program Receives: Other: Immunotherapy CARE Program |
| U&C Group | No intervention | Enhanced Usual and Customary care and support (U\&C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Checkpoint Inhibitors/ICI continuation
Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start9 Jun 2026
- Primary completion9 Jun 2029 (estimated)
- Study completion9 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Gany, MD, MS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646847
- Sponsor's protocol ID
- 25-338
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation
- ClinicalTrials.gov ID
- NCT07646847
- Acronym / sponsor ID
- 25-338
- Conditions
- Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer
- Keywords
- Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer, Memorial Sloan Kettering Cancer Center, 25-338
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 9 Jun 2029 (estimated)
- Study completion
- 9 Jun 2029 (estimated)
- First posted
- 15 Jun 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 find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I CARE Group | Experimental | Other: Immunotherapy CARE ProgramImmunotherapy CARE Program |
| U&C Group | No intervention | –Enhanced Usual and Customary care and support (U\&C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Documentation of Disease
- o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)
- Prior Treatment
- o Within three weeks (+/- 3 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)
- Age ≥ 18 (per EMR)
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 |
|---|---|---|
| Immunotherapy CARE ProgramAlso: I CAREFor participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation | Other | I CARE Group |
Primary outcome
Immune Checkpoint Inhibitors/ICI continuation
Time frame: 6 months
Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months
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 20 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.
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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.
Francesca Gany, MD, MS principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunotherapy CARE Program in people with Kidney Cancer and Bladder Cancer, run by Memorial Sloan Kettering Cancer Center at 8 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 11 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 20 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 8 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.
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 Francesca Gany, MD, MS (646-888-8054, ganyf@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Checkpoint Inhibitors/ICI continuation (time frame: 6 months). 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 20 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.