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ACTIVE NOT RECRUITING Phase 1

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

NCT03611868 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Phase 1b: APG-115+pembrolizumab

Study Locations (20)

California

  • UCLA Hematology & Oncology Clinic — Los Angeles
  • Sarcoma Oncology Research Center — Santa Monica

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati
  • Cleveland Clinic — Cleveland

Pennsylvania

  • Penn State Hershey Medical Center Cancer Institute — Hershey
  • Thomas Jefferson University Hospital — Philadelphia

Texas

  • University of Texas MD Anderson Cancer Center — Houston
  • Next Oncology — San Antonio

Queensland

  • Metro South Hospital and Health Services via Princess Alexandra Hospital — Brisbane
  • Queensland Children's Hospital — South Brisbane

Arizona

  • University of Arizona Cancer Center — Tucson

Arkansas

  • Highlands Oncology — Rogers

District of Columbia

  • Children's National Research Institute — Washington D.C.

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2018-08-29
Est. Completion 2025-12-30
Phase Phase 1

Sponsor

Ascentage Pharma Group

98 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03611868

The ClinicalTrials.gov registry entry for NCT03611868 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascentage Pharma Group, which has 98 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 8 conditions, with Melanoma appearing as the primary indexed condition, and to 1 intervention — of which Phase 1b: APG-115+pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03611868 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03611868 about?

NCT03611868 is a clinical study titled "A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors". 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 hyp...

What is the current status of trial NCT03611868?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 230 participants. The study started on 2018-08-29. Estimated completion is 2025-12-30.

What conditions does trial NCT03611868 study?

This clinical trial studies the following conditions: Melanoma, Cutaneous Melanoma, Uveal Melanoma, Mucosal Melanoma, Malignant Peripheral Nerve Sheath Tumors (MPNST). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03611868?

The interventions under investigation include: Phase 1b: APG-115+pembrolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03611868?

This trial is sponsored by Ascentage Pharma Group, which has 98 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03611868 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial