Axitinib + Ipilimumab in Advanced Melanoma

NCT04996823 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MCC-2111263403991
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if taking axitinib with ipilimumab is effective in treating advanced melanoma.

Conditions

Melanoma

Keywords

skin cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Progression Free Survival

  Up to 5 years

• Overall Survival

  Up to 5 years

• Duration of Response

  Up to 5 years

• Clinical Benefit Rate

  Up to 12 months

Study Arms (1)

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

Drug: Ipilimumab; Drug: Axitinib

Interventions

Ipilimumab DRUG

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

Also known as: Yervoy

Ipilimumab + Axtinib

Axitinib DRUG

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

Also known as: Inlyta

Ipilimumab + Axtinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Ipilimumab; Axitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zeynep Eroglu, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnay Marshall

CONTACT

813-745-5938; Arnay.Marshall@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: August 4, 2021
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): March 29, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)