Any Advanced Solid TumorsPhase 2IRISNCT07836101
Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events
A Phase 2 study testing Sarilumab and ICI Therapy in people with Any Advanced Solid Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The study will enroll patients with history of malignancy treated with immune checkpoint inhibitors (ICI) that have developed a grade 2 or higher immune related adverse event requiring treatment discontinuation as deemed by the patient's treating physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Advanced Solid Tumors
- What is being tested?
- Sarilumab and ICI Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2029
- Phase
- Phase 2
- 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
- Eligible patients include patients with malignancy treated with ICI, who have been diagnosed with a clinically significant irAE (grade 1-3 attributed to ICI per CTCAE v6.0) requiring interruption of ICI by the treating physician. This study is limited to patients with the following specific irAEs as IL-6R blockade has demonstrated effectiveness in these conditions. Specific toxicities eligible for inclusion are; arthritis, colitis, PMR, nephritis, pneumonitis, hepatitis, myositis
- The risk/benefit profile must favor ICI rechallenge as deemed per treating oncologist
- The irAE must have improved to grade 1 by CTCAE criteria v6.0 for at least 1 week (exception for patients who have endocrinopathies which will typically require lifelong hormone supplementation)
- Be willing and able to provide informed consent/assent for the trial
- Be ≥18 years of age on the day of signing informed consent
- Female subject of childbearing potential must have a negative urine or serum pregnancy test within 2 weeks prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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- Women of child-bearing potential (WOCBP):
- Agree to use contraception while participating in this study, and for a period of 6 months following last dose of Sarilumab or ICI, as effects of these agents on the developing human fetus are unknown. Men whose partner is a WOCBP must also agree to use contraception during this period. Negative pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within two weeks of registration. Women must not be breastfeeding or plan to breastfeed for the duration of therapy or 6 months after.
- Males must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 3 months after last dose of sarilumab, 120 days even if he has undergone a successful vasectomy
- Have adequate organ function as described below
- Absolute neutrophil count (ANC) ≥500/mm3
- Platelets ≥ 50,000/mm3
- AST/ALT <=3× institutional upper limit of normal
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Completed informed consent process, including signing Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form.
- Willing and able to comply with clinical trial instructions and requirements. Subjects must be competent to report AEs, understand the drug dosing schedule, and use of medications to control AEs
Who cannot join
- History of grade 4 irAE (attributed to ICI per CTCAE v6.0)
- History of cardiovascular or neurologic immune related adverse event
- Active or serious infections
- History of latent Tuberculosis (TB) or uncontrolled hepatitis B/C
- History of gastrointestinal perforation or diverticulitis
- Severe hepatic impairment (AST, ALT >3xULN; total bilirubin >1.5xULN)
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- Significant hematological abnormalities
- On prednisone equivalent >10mg prior to first dose of trial treatment
- History of immunodeficiency disorder
- Treatment with a non-biologic immunosuppressive or immune-modulating drug (e.g. methotrexate, azathioprine, mycophenolate, cyclosporine, hydroxychloroquine, penicillamine) at time of enrollment
- Treatment with other immune-modulating biologic agents (e.g TNF-alpha inhibitors) within 8 weeks prior to enrollment
- History of anaphylaxis or IgE-mediated hypersensitivity to sarilumab or history of allergic reactions attributed to compounds of similar chemical or biologic composition to sarilumab.
- The subject must meet all of the inclusion criteria and none of the exclusion criteria.
- No eligibility waivers will be granted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Danielle Wendler, 410-502-5140, JHCTN@jhmi.edu
Chelsea Miralles, 4109559923, cmirall1@jhmi.edu
About this study
Official title: Phase II Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events (The IRIS Trial: Immune Checkpoint Inhibitor Rechallenge Involving Sarilumab)
The study will enroll patients with history of malignancy treated with immune checkpoint inhibitors (ICI) that have developed a grade 2 or higher immune related adverse event requiring treatment discontinuation as deemed by the patient's treating physician. Patients will be sequentially enrolled into the single-arm study after meeting the pre-specified eligibility criteria
- Conditions
- Any Advanced Solid Tumors
- Being tested
- Sarilumab, ICI Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarilumabDrug
Sarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks.
ICI TherapyDrug
ICI will be administered on day 1 of each 3 or 4 week cycle depending on the selected ICI agent. Administration of ICI will continue past the 24 week timepoint per discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab with ICI | Experimental | Sarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks. ICI will be dosed by investigator's choice per standard of care for malignancy. ICI will be administered on day 1 of each 3 or 4 week cycle depending on the selected ICI agent. Administration of ICI will continue past the 24 week timepoint per discretion of the investigator. Receives: Drug: Sarilumab; Drug: ICI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE)
Absence of any grade ≥2 Immune Related Adverse Event (irAE) in the 3 months after ICI rechallenge, defined as grade ≥2 adverse event attributed to ICI by CTCAE v6.0
Measured: From enrollment to the end of treatment at 53 weeks
Secondary outcomes (4)
Safety and tolerability as assessed by occurrence of adverse events
Safety and tolerability will be measured by occurrence of grade ≥3 adverse events as measured by CTCAE v6.0 and patient reported outcomes (PROs) as assessed by PRO-CTCAE v1.0.
Measured: From enrollment to the end of treatment at 53 weeks
Absence of Serious immune-related adverse event
To assess to the safety of Immune Checkpoint Inhibitor (ICI) rechallenge with sarilumab with respect to serious irAE of grade ≥2 in patients with a history of non- cardiovascular and non-neurologic clinically significant irAEs.
Measured: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by progression free survival
Cancer outcomes will be measured by progression free survival (PFS). PFS is defined as the time from first dose of sarilumab + ICI rechallenge until investigator-assessed radiological progressive disease (PD) or death, whichever comes first.
Measured: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by Overall survival
Cancer outcomes will be measured by overall survival (OS).Overall survival is defined as the time from first dose of sarilumab + ICI rechallenge until death.
Measured: From enrollment to the end of treatment at 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, single-arm phase 2 clinical trial evaluating the safety of sarilumab with ICI rechallenge in patients with a history of a clinically significant immune related adverse event.
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Regeneron, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Aliyah Pabani, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836101
- Sponsor's protocol ID
- J2687
- Other IDs
- 15845, IRB00559848
- Acronym
- IRIS
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sarilumab With Immune Checkpoint Inhibitor Rechallenge in Patients With Clinically Significant Immune Related Adverse Events (The IRIS Trial: Immune Checkpoint Inhibitor Rechallenge Involving Sarilumab)
- ClinicalTrials.gov ID
- NCT07836101
- Acronym / sponsor ID
- IRIS / J2687
- Conditions
- Any Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Sanofi-Regeneron, Bristol-Myers Squibb
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Sep 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 study will enroll patients with history of malignancy treated with immune checkpoint inhibitors (ICI) that have developed a grade 2 or higher immune related adverse event requiring treatment discontinuation as deemed by the patient's treating physician. Patients will be sequentially enrolled into the single-arm study after meeting the pre-specified eligibility criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, single-arm phase 2 clinical trial evaluating the safety of sarilumab with ICI rechallenge in patients with a history of a clinically significant immune related adverse event.
| Arm | Type | Receives |
|---|---|---|
| Sarilumab with ICI | Experimental | Drug: Sarilumab, Drug: ICI TherapySarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks. ICI will be dosed by investigator's choice per standard of care for malignancy. ICI will be administered on day 1 of each 3 or 4 week cycle depending on the selected ICI agent. Administration of ICI will continue past the 24 week timepoint per discretion of the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Eligible patients include patients with malignancy treated with ICI, who have been diagnosed with a clinically significant irAE (grade 1-3 attributed to ICI per CTCAE v6.0) requiring interruption of ICI by the treating physician. This study is limited to patients with the following specific irAEs as IL-6R blockade has demonstrated effectiveness in these conditions. Specific toxicities eligible for inclusion are; arthritis, colitis, PMR, nephritis, pneumonitis, hepatitis, myositis
- The risk/benefit profile must favor ICI rechallenge as deemed per treating oncologist
- The irAE must have improved to grade 1 by CTCAE criteria v6.0 for at least 1 week (exception for patients who have endocrinopathies which will typically require lifelong hormone supplementation)
- Be willing and able to provide informed consent/assent for the trial
- Be ≥18 years of age on the day of signing informed consent
Key exclusion criteria (14 listed)
- History of grade 4 irAE (attributed to ICI per CTCAE v6.0)
- History of cardiovascular or neurologic immune related adverse event
- Active or serious infections
- History of latent Tuberculosis (TB) or uncontrolled hepatitis B/C
- History of gastrointestinal perforation or diverticulitis
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 |
|---|---|---|
| SarilumabSarilumab is dosed 200 mg subcutaneously every two weeks for a total of 24 weeks. | Drug | Sarilumab with ICI |
| ICI TherapyICI will be administered on day 1 of each 3 or 4 week cycle depending on the selected ICI agent. Administration of ICI will continue past the 24 week timepoint per discretion of the investigator. | Drug | Sarilumab with ICI |
Primary outcome
Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE)
Time frame: From enrollment to the end of treatment at 53 weeks
Absence of any grade ≥2 Immune Related Adverse Event (irAE) in the 3 months after ICI rechallenge, defined as grade ≥2 adverse event attributed to ICI by CTCAE v6.0
4 secondary outcomes
Safety and tolerability as assessed by occurrence of adverse events
Time frame: From enrollment to the end of treatment at 53 weeks
Absence of Serious immune-related adverse event
Time frame: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by progression free survival
Time frame: From enrollment to the end of treatment at 53 weeks
Efficacy as assessed by Overall survival
Time frame: From enrollment to the end of treatment at 53 weeks
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 28 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Aliyah Pabani, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab and ICI Therapy in people with Any Advanced Solid Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 16 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Danielle Wendler (410-502-5140, JHCTN@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by Absence of any grade ≥2 Immune Related Adverse Event (irAE) (time frame: From enrollment to the end of treatment at 53 weeks). 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 28 Oct 2026.