Ireland
--:--IST
Active, not recruiting Phase 1/2

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

NCT04592653 · tracked via the Priya Life Science Spain tracker
Sponsor
Mural Oncology, Inc
Phase
Phase 1/2
Started
2020-09-30
Last updated
2024-06-07

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

Nemvaleukin alfaPembrolizumab →

Nemvaleukin alfa: IV infusion over 30 minutes

Pembrolizumab: IV infusion over 30 minutes

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) — From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
    Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
  • Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies — From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy
  • Incidence of dose-limiting toxicity (DLT) — From the first dose through end of dose-limiting toxicity observation period (up to 24 months)

Trial sites (6)

FacilityCityRegionStatus
START Midwest Grand Rapids Michigan
MD Anderson Cancer Center Houston Texas
START Mountain West Valley City Utah
NEXT Virginia Fairfax Virginia
Hospital Clinico San Carlos Madrid Spain
CIOCC HM Sanchinarro Madrid Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04592653 on ClinicalTrials.gov ↗ ← All trials in Spain