Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

The study will be conducted in 2 cohorts. A single-center design for the tumor microenvironment (TME) cohort (Cohort 1), and a multicenter design for the less frequent intravenous (IV) dosing cohort (Cohort 2).

Key facts

Study ID: NCT04592653
Run by: Mural Oncology, Inc
People needed: 78
Starts: 2020-09-30
Expected to finish: 2024-12-01
Last updated by the study team: 2024-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed diagnosis of an advanced solid tumor type of cutaneous melanoma, RCC, TNBC, MSS colorectal cancer, MSI-H solid tumors (NOS), or ovarian cancer with at least 1 accessible lesion for biopsy (Cohort 1 TME)
Patients must have histologically or cytologically confirmed epithelial tumor of the fallopian tube, peritoneum, or ovaries, cervical cancer, endometrial cancer, non-small cell lung adenocarcinoma, small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, esophageal cancer (squamous and adeno cell type), pancreatic cancer, biliary tract tumor (including intra- and extrahepatic cholangiocarcinoma, gall bladder, ampullary type), cutaneous melanoma, mucosal melanoma, head and neck squamous cell carcinoma, or metastatic or advanced breast cancer after treatment failure or intolerance of 1 to 3 established indication specific therapies (Cohort 2)
Patient must have received 1 to 3 prior FDA-approved targeted therapies, failure of adjuvant and neoadjuvant therapy is considered 1 line of treatment
All patients' baseline biopsies must be taken no more than 3 months before Screening and at least 4 weeks after completion of last antineoplastic therapy
Patients must have at least 1 lesion that qualifies as a target lesion
Patients must have adequate hematologic reserve
Patients must have adequate hepatic and renal function
For Cohort 1 (TME) and Part A of Cohort 2 (less frequent IV dosing), treatment with prior immunotherapy is permitted unless the patient has previously experienced grade ≥3 autoimmune toxicity or drug-related toxicity requiring discontinuation. Patients in Part B of Cohort 2 (less frequent IV dosing) who received prior anti-PD-(L)1 for at least 3 months may enroll if they had a response of stable disease or better
For Cohort 1 (TME), patients who have received prior anti-PD-1 directed therapy must wait at least 4 weeks from last dose of such therapy before the Screening biopsy is collected
Women of childbearing potential (WOCBP) must have a negative pregnancy test
Additional criteria may apply

You may not qualify if…

Patients with active or symptomatic central nervous system metastases
Patients who require pharmacologic doses of systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent)
Patients known to be positive for HIV and/or history of hepatitis B, or C infections or is known to be positive for hepatitis B antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C antibody (Hep C Ab) or RNA.
Patients with a known additional malignancy within 2 years of the start of Screening
Patients who have received radiotherapy within the last 4 weeks before start of study treatment
Patients who have received systemic immunomodulatory agents within 4 weeks or 5 half lives, whichever is shorter, before Cycle 1 Day 1,
Patients who have received prior IL-2-based or IL-15-based soluble protein therapy at any time in the past are excluded
Additional criteria may apply

Where it is running

START Midwest — Grand Rapids, Michigan, United States
MD Anderson Cancer Center — Houston, Texas, United States
START Mountain — West Valley City, Utah, United States
NEXT Virginia — Fairfax, Virginia, United States
Hospital Clinico San Carlos — Madrid, Spain
CIOCC HM Sanchinarro — Madrid, Spain

Full record on ClinicalTrials.gov

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