Georgia's Online Cancer Information Center

Find A Clinical Trial

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)

Status
Active
Cancer Type
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03861793
Protocol IDs
ALKS 4230-001 (primary)
NCI-2019-02348
Study Sponsor
Alkermes, Inc.

Summary

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.

Objectives

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

Eligibility

  1. For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
  2. Subject must have at least one target lesion based on RECIST
  3. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
  4. Subjects must have adequate liver function
  5. Subjects must have adequate kidney function
  6. Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
  7. Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
  8. Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered
  9. Subject will agree to follow contraceptive requirements defined in the protocol
  10. Additional criteria may apply

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.