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Clinical Trial 21112

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT04996823

Phase: Phase II
Principal Investigator: Eroglu, Zeynep

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Summary

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.

Objective

1.To evaluate the anti-tumor activity of axitinib + ipilimumab in patients with advanced melanoma 2. To evaluate the safety and tolerability of axitinib in combination with ipilimumab in patients with advanced melanoma 3. To estimate median progression free survival 4. To estimate clinical benefit rate 5. To estimate median overall survival 6. To evaluate duration of response

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

Ipilimumab (); Yervoy (Ipilimumab); axitinib (AG-013736)

Inclusion Criteria

Inclusion Criteria:

Diagnosis of advanced/unresectable melanoma - uveal melanoma is excluded

ECOG performance status ≤ 2

Adequate bone marrow, organ function and laboratory parameters as defined in protocol.

Patients must have adequately controlled blood pressure (> 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 of 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

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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.