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NCT03611868 · ClinicalTrials.gov registry record · Phase 1
A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors
A Phase 1 study of Melanoma and Cutaneous Melanoma, sponsored by Ascentage Pharma Group.
- Active
- Registry status
- Phase 1
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT03611868: Active Phase 1 study of Melanoma and Cutaneous Melanoma, sponsored by Ascentage Pharma Group.
NCT03611868 is a Phase 1 study of Melanoma and Cutaneous Melanoma that is active but no longer recruiting, run by Ascentage Pharma Group. The registered enrollment target is 230 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03611868, a Phase 1 study of Melanoma and Cutaneous Melanoma, is active but no longer recruiting, sponsored by Ascentage Pharma Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Part I is to assess the safety and tolerability of APG-115 by assessing the dose-limiting toxicity (DLT) of APG-115 in combination with pembrolizumab. End points included: Incidence of DLTs during the first 3 weeks of treatment of each dose cohort; Severity and frequency of any adverse event(s) (AE) and serious adverse event(s) (SAE) based on NCI CTCAE 5.0
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2018-08-29 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 1 |
What the registry record for NCT03611868 still lists
NCT03611868 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (67% lower).
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.
NCT03611868 names 20 study sites across 15 states, led by California, Ohio, Pennsylvania.
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).
What interventions are being tested in trial NCT03611868?
The interventions under investigation include: Phase 1b: APG-115+pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03611868?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03611868's enrollment target sits among peer trials
230 65th of 266 higher than 201 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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