MelanomaPhase 2NCT04996823
Axitinib + Ipilimumab in Advanced Melanoma
A Phase 2 study testing Ipilimumab and Axitinib in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Ipilimumab and Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 29 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
- Diagnosis of advanced/unresectable melanoma - uveal melanoma is excluded
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow, organ function and laboratory parameters as defined in protocol.
- Patients must have adequately controlled blood pressure (<150 systolic and <100 diastolic)
- At least 1 measurable lesion - per irRECIST 1.1 criteria
- Documented disease refractory or intolerant to anti-PD-1/PD-L1 inhibitor treatment: in the metastatic setting or in the adjuvant setting if relapse on or within 6 months from end of anti-PD-1 treatment
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- If BRAFV600-mutant melanoma, patients may have had prior BRAF/MEK inhibitor therapy, or intolerance to these drugs
- No limit to prior lines of treatment but prior ipilimumab not permitted
- Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline
- Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Prior to first dose of study treatment, patients must be at least 2 weeks from any prior major surgery.
- Able to undergo a pre-treatment and on-treatment tumor biopsy
- Female participants of childbearing potential must have a negative serum or urine β-HCG test result. Female participants of childbearing potential and male participants must agree to use methods of contraception that are highly effective. Pregnant or breast-feeding patients are not permitted to enroll.
- Patients with brain metastases are permitted assuming that the brain metastases have been adequately treated previously. Patients with uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable or require corticosteroids are not permitted,
- Active autoimmune disease requiring disease-modifying therapy at the time of screening is not permitted. Replacement therapy (e.g., physiologic corticosteroid therapy) is allowed
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to screening. Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to study start.
Who cannot join
- In patients with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment are excluded.
- Patients with Grade ≥3 hemorrhage within 4 weeks are excluded
- Patients with severe/unstable angina or symptomatic congestive heart failure within last 6 months are excluded
- Patients with cerebrovascular accident, transient ischemic attack within last 6 months are excluded.
- Patients with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or strong CYP3A4/5 inducers, including their administration within 10 days prior to treatment start, are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma
The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.
Read the detailed description
The safety and tolerability of the combination of ipilimumab and axitinib will be tested in advanced melanoma patients who are intolerable/refractory to anti-PD-1/PD-L1 therapy and have not previously received treatment with ipilimumab.
- Conditions
- Melanoma
- Being tested
- Ipilimumab, Axitinib
- Keywords
- skin cancer
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpilimumabDrug
Also called Yervoy
Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.
AxitinibDrug
Also called Inlyta
Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab + Axtinib | Experimental | Participants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days Receives: Drug: Ipilimumab; Drug: Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per irRECIST and RECIST v1.1 criteria.
Measured: Up to 24 months
Secondary outcomes (4)
Progression Free Survival
Progression Free Survival (PFS) is defined as the length of time from start of study treatment to the earlier of the first documentation of disease progression or death from any cause.
Measured: Up to 5 years
Overall Survival
Overall Survival (OS) is defined as the length of time from start of treatment to date of death from any cause.
Measured: Up to 5 years
Duration of Response
Duration of Response is defined as the interval from the first documentation of Complete Response (CR) or Partial Response (PR) to documentation of progressive disease or death from any cause.
Measured: Up to 5 years
Clinical Benefit Rate
Clinical Benefit Rate is defined as the proportion of patients who achieve a Complete Response (CR), Partial Response (PR) or durable Stable Disease (SD) of at least 6 months from start of study treatment.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start4 Aug 2021
- Primary completion20 Aug 2026 (estimated)
- Study completion29 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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Zeynep Eroglu, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996823
- Sponsor's protocol ID
- MCC-21112
- Other IDs
- 63403991
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT04996823
- Acronym / sponsor ID
- MCC-21112
- Conditions
- Melanoma
- Keywords
- skin cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 9 Aug 2021 (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 goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.
Detailed description
The safety and tolerability of the combination of ipilimumab and axitinib will be tested in advanced melanoma patients who are intolerable/refractory to anti-PD-1/PD-L1 therapy and have not previously received treatment with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab + Axtinib | Experimental | Drug: Ipilimumab, Drug: AxitinibParticipants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of advanced/unresectable melanoma - uveal melanoma is excluded
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate bone marrow, organ function and laboratory parameters as defined in protocol.
- Patients must have adequately controlled blood pressure (<150 systolic and <100 diastolic)
- At least 1 measurable lesion - per irRECIST 1.1 criteria
Key exclusion criteria (5 listed)
- In patients with known liver cirrhosis, those with severe (Child Pugh C) hepatic impairment are excluded.
- Patients with Grade ≥3 hemorrhage within 4 weeks are excluded
- Patients with severe/unstable angina or symptomatic congestive heart failure within last 6 months are excluded
- Patients with cerebrovascular accident, transient ischemic attack within last 6 months are excluded.
- Patients with current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors or strong CYP3A4/5 inducers, including their administration within 10 days prior to treatment start, are excluded.
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 |
|---|---|---|
| IpilimumabAlso: YervoyParticipants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses. | Drug | Ipilimumab + Axtinib |
| AxitinibAlso: InlytaParticipants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months) | Drug | Ipilimumab + Axtinib |
Primary outcome
Overall Response Rate
Time frame: Up to 24 months
Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per irRECIST and RECIST v1.1 criteria.
4 secondary outcomes
Progression Free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Clinical Benefit Rate
Time frame: Up to 12 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 30 Jul 2026.
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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.
Zeynep Eroglu, MD principal investigator
Moffitt Cancer Center
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 Ipilimumab and Axitinib in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 5 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 30 Jul 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?
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?
Overall Response Rate (time frame: Up to 24 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 30 Jul 2026.