Axitinib + Ipilimumab in Advanced Melanoma

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04996823
Collaborator
Pfizer (Industry)
25
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma
Actual Study Start Date :
Aug 2, 2021
Anticipated Primary Completion Date :
Aug 2, 2024
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [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.

    Secondary Outcome Measures

    1. Progression Free Survival [Up to 5 years]

      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.

    2. Overall Survival [Up to 5 years]

      Overall Survival (OS) is defined as the length of time from start of treatment to date of death from any cause.

    3. Duration of Response [Up to 5 years]

      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.

    4. Clinical Benefit Rate [Up to 12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Moffitt Cancer CenterTampaFloridaUnited States33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • Pfizer

    Investigators

    • Principal Investigator: Zeynep Eroglu, MD, Moffitt Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT04996823
    Other Study ID Numbers:
    • MCC-21112
    • 63403991
    First Posted:
    Aug 9, 2021
    Last Update Posted:
    Jan 20, 2022
    Last Verified:
    Jan 1, 2022
    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
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 20, 2022