Overview

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