Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma


About this study

The purpose of this study is to observe the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- The patient must have the following tumor types:

Cohort 1: Patient has unresectable and/or metastatic cutaneous melanoma. No more than 5
patients with acral melanoma may enroll in this cohort.

Cohort 2: Patient has unresectable and/or metastatic mucosal melanoma.

Cohort 3: Patient has unresectable and/or metastatic cutaneous melanoma. Patients with
acral melanoma may not enroll in this cohort.

- The patient must have received previous treatment as follows:

1. Patient has received anti-PD-[L]1 therapy with or without anti-CTLA-4 therapy,
and no more than one other prior regimen of systemic anti-neoplastic therapy (eg,
targeted therapy, chemotherapy). Previous adjuvant and/or neoadjuvant therapy
counts as one prior regimen.

2. Patients have experienced objective response (partial response [PR] or CR; by
RECIST 1.1 or iRECIST) or stable disease (SD; by RECIST 1.1 or iRECIST) as best
overall response (BOR) to anti-PD-[L]1 therapy. Patients with confirmed
progressive disease (by RECIST 1.1 or iRECIST) as best response may be included,
if they received anti-PD-[L]1 therapy for a minimum of 12 weeks (eg, from first
dose to last dose).

3. Patients with BRAF mutations may or may not have received prior targeted therapy.

- Patients must have disease that is measurable based on RECIST 1.1., that has not
recently been irradiated or used to collect a biopsy.

- Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying
archival tumor tissue.

- Patient has an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 and an
estimated life expectancy of ≥3 months.

- Additional criteria may apply.

Exclusion Criteria:

- Patient has uveal melanoma (all cohorts) or acral melanoma (Cohort 2 and Cohort 3).

- Patient has received prior interleukin (IL)-2-based or IL-15-based cytokine therapy;
patient has had exposure, including intralesional, to IL-12 or analogs thereof.

- Patient requires systemic corticosteroids (>10 mg of prednisone daily, or equivalent)
however, replacement doses, topical, ophthalmologic, and inhalational steroids are

- Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell
or bone marrow transplant.

- Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to
begin breastfeeding during the study period or within 30 days after last study drug

- Patients with active or symptomatic central nervous system metastases unless the
metastases have been treated by surgery and/or radiation therapy and/or gamma knife,
the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less
of corticosteroids for at least 2 weeks before the first dose, and the subject is
neurologically stable. Patients with leptomeningeal disease are excluded.

- Patient has known or suspected hypersensitivity to any components of nemvaleukin.

- Patients with an uncontrollable bleeding disorder.

- Patient has QT interval corrected by the Fridericia Correction Formula values of >470
msec (in females) or >450 msec (in males); patient who is known to have congenital
prolonged QT syndromes; or patient who is on medications known to cause prolonged QT
interval on ECG.

- Patient has developed Grade ≥3 immune-related AEs (irAEs) while on prior
immunotherapy, (eg, pneumonitis and nephritis) and has not recovered to ≤Grade 1
and/or are on systemic steroids within 14 days of first dose of study drug.

- Patients who have previously discontinued immunotherapy due to immune-related adverse
event (irAEs) will be excluded.

- Additional criteria may apply.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 4/17/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Roxana Dronca, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Block, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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