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Clinical Trial 18826

Cancer Type: Genitourinary
Interventions:ALKS 4230; Pembrolizumab (Keytruda)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Jameel Muzaffar

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Summary

The purpose of this study is to find answers to the following research questions: * (Part A only) What is the highest dose of ALKS 4230 that can be given to participants when given for 5 days every 3 weeks? * Are there any side effects caused by taking ALKS 4230? * How much ALKS 4230 is in the blood at specific times after dosing and how does the body get rid of the ALKS 4230? * Does ALKS 4230 provide any benefit to people with advanced solid tumors?

Objective

Primary: To investigate the safety and tolerability of ALKS 4230 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of ALKS 4230 in subjects with advanced solid tumors who are refractory or intolerant to therapies known to provide clinical benefit. Secondary: To describe the dose-limiting toxicity (DLT) of ALKS 4230; To describe the adverse event (AE) profile of ALKS 4230; To characterize the clinical pharmacokinetic (PK) profile and immunogenicity of ALKS 4230; To investigate the clinical pharmacodynamic effects of ALKS 4230; To describe any antitumor activity and responses observed with ALKS 4230.

Inclusion Criteria

  • For Part A, the participant has histological or cytological evidence of a solid tumor; for Part B, the participant has histological or cytological evidence of 1 of the following solid tumor types: melanoma, renal cell carcinoma, or ovarian cancer.
  • All participants must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies.
  • Participants enrolled in Part B must have at least 1 lesion that may qualify as a target lesion.
  • Participant can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months.
  • Must have adequate hematologic reserve.
  • Must have adequate liver function.
  • Must have adequate kidney function.
  • Must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery.
  • Potential participants who have received investigational agents must wait at least 4 weeks.
  • 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.
  • Meets contraceptive requirements defined in the protocol.
  • Additional criteria may apply.

  • Exclusion Criteria

  • Is currently pregnant or breastfeeding, or is planning to become pregnant during the study.
  • An active infection or with a fever >/+ 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1.
  • Active or symptomatic central nervous (CNS) system metastases. Potential participants with CNS system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the participant is off corticosteroids for at least 2 weeks and is neurologically stable.
  • Have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males).
  • A known hypersensitivity to any components of ALKS 4230.
  • Require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
  • Developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy.
  • 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.
  • Known to be positive for human immunodeficiency virus (HIV), hepatitis B or C.
  • Additional criteria may apply.