Axitinib + Ipilimumab in Advanced Melanoma

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Ipilimumab; Drug: Axitinib

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arnay Marshall; Phone Number: 813-745-5938; Email: Arnay.Marshall@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Nikhil Khushalani, MD
      • Sub-Investigator: Andrew Brohl, MD
      • Sub-Investigator: Joseph Markowitz, MD, PhD
      • Principal Investigator: Zeynep Eroglu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Ipilimumab; Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.; Other Names: Yervoy; Drug: Axitinib; Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months); Other Names: Inlyta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Pfizer
• Investigators: Principal Investigator: Zeynep Eroglu, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): March 29, 2027

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: skin cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin and Connective Tissue Diseases; Melanoma; Skin Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Amides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Benzamides; Indazoles; Pyrazoles; Axitinib; Ipilimumab
• Other Study ID Numbers: MCC-21112; 63403991 (Other Identifier: Pfizer)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes