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

NCT ID: NCT04592653

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2024-12-31

Brief 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).

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Tumor Microenvironment (TME) Nemvaleukin and Pembrolizumab

Nemvaleukin will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of nemvaleukin

Group Type: EXPERIMENTAL

Nemvaleukin alfa

Intervention Type: BIOLOGICAL

IV infusion over 30 minutes

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion over 30 minutes

Cohort 2 Part A: Less Frequent IV Dosing Nemvaleukin

Group Type: EXPERIMENTAL

Nemvaleukin alfa

Intervention Type: BIOLOGICAL

IV infusion over 30 minutes

Cohort 2 Part B: Less Frequent IV Dosing Nemvaleukin and Pembrolizumab

This arm will not open for enrollment.

Group Type: EXPERIMENTAL

Nemvaleukin alfa

Intervention Type: BIOLOGICAL

IV infusion over 30 minutes

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion over 30 minutes

Interventions

Nemvaleukin alfa

IV infusion over 30 minutes

Intervention Type: BIOLOGICAL

Pembrolizumab

IV infusion over 30 minutes

Intervention Type: BIOLOGICAL

Other Intervention Names

ALKS 4230; Keytruda

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mural Oncology, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Mural Oncology

Locations

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

Countries

United States; Spain

Other Identifiers

ALKS 4230-003

Identifier Type: -

Identifier Source: org_study_id