๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-04

A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors (NCT03611868)

A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination With Pembrolizumab in Patients With Unresectable or Metastatic Melanomas or Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Ascentage Pharma Group Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of APG-115, an MDM2 inhibitor, either alone or in combination with pembrolizumab, a programmed cell death protein-1 (PD-1) inhibitor, in patients with metastatic melanomas or advanced solid tumors. Our hypothesis is that restoration of the immune response concomitant to inhibition of the MDM2 pathway (which restores p53 functions) may promote cancer cell death, leading to effective anticancer therapy.

Who can join: Review the eligibility criteria below.

Location: University of Arizona Cancer Center โ€” Tucson, Arizona

Age range: 12 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (21 Sites)

  • University of Arizona Cancer Center โ€” Tucson, Arizona
  • Highlands Oncology โ€” Rogers, Arkansas
  • UCLA Hematology & Oncology Clinic โ€” Los Angeles, California
  • Sarcoma Oncology Research Center โ€” Santa Monica, California
  • Children's National Research Institute โ€” Washington D.C., District of Columbia
  • Sarah Cannon/FCSRI โ€” Fort Myers, Florida
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Memorial Sloan Kettering โ€” New York, New York
  • Duke Cancer Institute โ€” Durham, North Carolina
  • Cincinnati Children's Hospital Medical Center โ€” Cincinnati, Ohio
  • Cleveland Clinic โ€” Cleveland, Ohio
  • Penn State Hershey Medical Center Cancer Institute โ€” Hershey, Pennsylvania
  • Thomas Jefferson University Hospital โ€” Philadelphia, Pennsylvania
  • Sarah Cannon Cancer Center โ€” Nashville, Tennessee
  • University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • Next Oncology โ€” San Antonio, Texas
  • Virginia Cancer Specialists โ€” Fairfax, Virginia
  • Metro South Hospital and Health Services via Princess Alexandra Hospital โ€” Brisbane, Queensland
  • Queensland Children's Hospital โ€” South Brisbane, Queensland
  • Flinders Medical Centre โ€” Bedford Park, South Australia
  • Austin Health โ€” Heidelberg, Victoria

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—