New drug combo aims to fight melanoma when standard therapy fails
NCT ID NCT04996823
First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This phase 2 study tests whether combining two drugs—axitinib (a targeted therapy) and ipilimumab (an immunotherapy)—can shrink tumors in people with advanced melanoma that has stopped responding to standard treatment. The trial plans to enroll 25 participants. Researchers will measure how many patients see their tumors shrink or disappear, and how long they live without the disease getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- axitinib (Inlyta) and ipilimumab (Yervoy)
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced melanoma patients who no longer respond to standard immunotherapy.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The combination may cause significant side effects, and it is not expected to cure the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2021
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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