Axitinib + Ipilimumab in Advanced Melanoma

NCT ID: NCT04996823

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2027-03-29

Brief Summary

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipilimumab + Axtinib

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

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.

Axitinib

Intervention Type: DRUG

Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)

Interventions

Ipilimumab

Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.

Intervention Type: DRUG

Axitinib

Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)

Intervention Type: DRUG

Other Intervention Names

Yervoy; Inlyta

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeynep Eroglu, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Arnay Marshall

Role: CONTACT

Arnay.Marshall@moffitt.org

813-745-5938

Related Links

https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

63403991

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-21112

Identifier Type: -

Identifier Source: org_study_id