A Study of ALKS 4230 (Nemvaleukin Alfa) on the Tumor Microenvironment

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effects of ALKS 4230 monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed diagnosis of an advanced solid malignancy (cutaneous melanoma, RCC, TNBC, Microsatellite-stable (MSS) colorectal cancer, Microsatellite-high (MSI-H) solid tumors [not otherwise specified], or ovarian cancer) after treatment failure or intolerance to at least one established, indication-specific therapy.

• Patients must be willing to provide tumor tissue biopsy and have accessible lesions for biopsy.

• All patients must provide a baseline biopsy from no more than 3 months prior to screening, and at least 4 weeks after completion of last anti-cancer therapy.

• Patients must have disease that is measurable by RECIST 1.1.

• Patients must demonstrate adequate organ function

• Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication

• Patients must agree to follow contraceptive requirements defined in the protocol

• Additional criteria may apply

Exclusion Criteria:

• Patient is pregnant or breastfeeding or is planning to become pregnant during the study period.

• Patients with an active infection or with a fever ≥38.5°C within 3 days of the first scheduled day of dosing

• Patients with primary CNS malignancy

• 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.

• Patients with hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients

• Patients who have received systemic immunomodulatory agents within 6 weeks prior to the first scheduled day of dosing

• Patients who have received prior IL-2-based or IL-15-based cytokine therapy at any time in the past

• Patients who require pharmacologic doses of systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent); however, topical, ophthalmologic, and inhalational steroids are permitted

• Patients with an uncontrollable bleeding disorder

• Patients known to be positive for human immunodeficiency virus 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 any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study.

• Additional criteria may apply