Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Pembrolizumab

Immunomodulating Agents

Interleukin-2

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

Nemvaleukin alfa

Director Global Clinical Services

Sonali Panchabhai

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).

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

Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3

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

Concentration data will be summarized by dose level

Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

Changes in absolute numbers of circulating leukocytes between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab

Mural Oncology, Inc

Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Stomach Neoplasms

Lung Neoplasms

Stomach Cancer

Antibodies

Immunoglobulins

Administered via SC injection once every 7 days or once every 21 days at escalating doses

ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230.

SC injection administered in the back of the arm or the abdomen

ALKS 4230

Administered as an intravenous (IV) infusion over 30 minutes

Mural Oncology Medical Director

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.

A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

At this time, IPD sharing has not been defined and/or decided if it will be shared.

Includes AEs that are both serious and drug-related

Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images

Overall response rate (ORR) will be based on investigator review of radiographic or photographic images

ORR will be based on investigator review of radiographic or photographic images

Time from first dose of SC ALKS 4230 to the time of progression or death

Time from first dose of SC ALKS 4230 to the time of death

Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)	NCT04592653	Advanced Solid ...	Nemvaleukin alf... Pembrolizumab	18 Years -	Mural Oncology, Inc
A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)	NCT03861793	Advanced Solid ...	ALKS 4230 Pembrolizumab	18 Years -	Mural Oncology, Inc

Spots Global Cancer Trial Database for nemvaleukin alfa