MelanomaPhase 2NCT05289193
CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma
A Phase 2 study testing PET Scan, Nivolumab and Ipilimumab in people with Melanoma and Melanoma Stage III, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Melanoma Stage III
- What is being tested?
- PET Scan, Nivolumab and Ipilimumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Mar 2022to 11 Mar 2027
- 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
- Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
- Adults at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Cytologically or histologically confirmed stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.
- Notes:
- In-transit melanoma is acceptable.
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- Patients can enroll regardless of their BRAF mutational status
- 1cm of tumor needs to be visible on standard imaging (i.e. FDG PET or CT scan)
- Screening laboratory values must meet the following criteria:
- WBC ≥ 2.0x109/L
- Neutrophils ≥ 1.5x109/L
- Platelets ≥ 100 x109/L
- Hemoglobin ≥ 5.5 mmol/L
- Creatinine ≤ 1.5x ULN
- AST ≤ 1.5 x ULN and ALT ≤ 1.5 x ULN
- Bilirubin ≤1.5 X ULN
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of study treatment (ipilimumab/nivolumab)
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab + nivolumab
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of study treatment (ipilimumab/nivolumab)
- Note: Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically sterile as well as azoospermic men do not require contraception
Who cannot join
- Subjects with any active autoimmune disease (current symptoms or requirement for immunosuppression at the time of study start).
- Positive active hepatitis B viral infection (+viral load by PCR)
- Prior immunotherapy targeting CTLA-4 and/or PD-1/PD-L1 for any disease.
- Potentially unresectable melanoma.
- History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- History of severe hypersensitivity reaction to any monoclonal antibody
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- Underlying medical conditions that, in the Investigator's opinion, will make the administration of treatment hazardous or obscure the interpretation of toxicity
- Patients who have undergone splenectomy or have other splenic disorders. The normal spleen usually has CD8+ cell activity and serves as a positive control to enable proper imaging technique.
- Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion
- Pregnant or nursing
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
- Conditions
- Melanoma, Melanoma Stage III
- Being tested
- PET Scan, Nivolumab, Ipilimumab, Surgical Resection of Melanoma
- Keywords
- CD8+ Cell Imaging, C-IT Neo Trial, stage III melanoma, 89Zr-Df-Crefmirlimab, Memorial Sloan Kettering Cancer Center, 21-456
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanDiagnostic test
Also called 89Zr-Df-Crefmirlimab
Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab
1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.
NivolumabDrug
Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab
1mg/kg + ipilimumab 3mg/kg.
IpilimumabDrug
Patients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab
1mg/kg + ipilimumab 3mg/kg.
Surgical Resection of MelanomaProcedure or surgery
Patients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab
1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Stage III Melanoma | Experimental | All participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed. Receives: Diagnostic Test: PET Scan; Drug: Nivolumab; Drug: Ipilimumab; Procedure: Surgical Resection of Melanoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic responses/MPR
Participants' disease will be assessed for MPR as per previously established criteria for neoadjuvant trials (near complete response ≤10% viable; complete response 0% viable). Pathologic response (≤50% viable) will also be estimated.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start11 Mar 2022
- Primary completion11 Mar 2027 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Postow, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289193
- Sponsor's protocol ID
- 21-456
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2022
- Last updated
- 7 Apr 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 beginning 12 months after publication and for up to 36 months post publication. 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD8+ Cell Imaging During Neoadjuvant ImmunoTherapy (The C-IT Neo Trial)
- ClinicalTrials.gov ID
- NCT05289193
- Acronym / sponsor ID
- 21-456
- Conditions
- Melanoma, Melanoma Stage III
- Keywords
- CD8+ Cell Imaging, C-IT Neo Trial, stage III melanoma, 89Zr-Df-Crefmirlimab, Memorial Sloan Kettering Cancer Center, 21-456
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Mar 2027 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 21 Mar 2022 (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.
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Stage III Melanoma | Experimental | Diagnostic Test: PET Scan, Drug: Nivolumab, Drug: Ipilimumab, Procedure: Surgical Resection of MelanomaAll participants will have cytologically or histologically confirmed stage IIIB, IIIC, IIID melanoma that can be surgically removed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
- Adults at least 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Cytologically or histologically confirmed stage IIIB, IIIC, IIID, or IV melanoma that can be surgically removed.
- In-transit melanoma is acceptable.
Key exclusion criteria (10 listed)
- Subjects with any active autoimmune disease (current symptoms or requirement for immunosuppression at the time of study start).
- Positive active hepatitis B viral infection (+viral load by PCR)
- Prior immunotherapy targeting CTLA-4 and/or PD-1/PD-L1 for any disease.
- Potentially unresectable melanoma.
- History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
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 |
|---|---|---|
| PET ScanAlso: 89Zr-Df-CrefmirlimabPatients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma. | Diagnostic test | Participants with Stage III Melanoma |
| NivolumabPatients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. | Drug | Participants with Stage III Melanoma |
| IpilimumabPatients will have a baseline CD8 PET scan prior to receiving one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. | Drug | Participants with Stage III Melanoma |
| Surgical Resection of MelanomaPatients will have a baseline CD8 PET scan prior to one dose of neoadjuvant nivolumab 1mg/kg + ipilimumab 3mg/kg. After 4 weeks, patients will have a repeat CD8 PET scan and then undergo surgical resection of their stage III melanoma. | Procedure or surgery | Participants with Stage III Melanoma |
Primary outcome
Major pathologic responses/MPR
Time frame: up to 2 years
Participants' disease will be assessed for MPR as per previously established criteria for neoadjuvant trials (near complete response ≤10% viable; complete response 0% viable). Pathologic response (≤50% viable) will also be estimated.
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 7 Apr 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 beginning 12 months after publication and for up to 36 months post publication. 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. This study is not recruiting at the moment.
Michael Postow, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET Scan, Nivolumab and Ipilimumab in people with Melanoma and Melanoma Stage III, run by Memorial Sloan Kettering Cancer Center at 4 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 20 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic responses/MPR (time frame: up to 2 years). 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 7 Apr 2026.