RECRUITING

Axitinib + Ipilimumab in Advanced Melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Quick Facts

Study Start:2021-08-04

Study Completion:2027-03-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04996823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Neelam Lal

CONTACT

813-745-4398

Neelam.Lal@moffitt.org

Principal Investigator

Zeynep Eroglu, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Zeynep Eroglu, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-04

Study Completion Date2027-03-29

Study Record Updates

Study Start Date2021-08-04

Study Completion Date2027-03-29

Terms related to this study

Keywords Provided by Researchers

skin cancer

Additional Relevant MeSH Terms

Melanoma