deltatrials
Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT03611868

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

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

Sponsor: Ascentage Pharma Group Inc.

Conditions Cutaneous Melanoma MDM2 Gene Mutation Malignant Peripheral Nerve Sheath Tumors (MPNST) Melanoma Mucosal Melanoma P53 Mutation Unresectable or Metastatic Melanoma or Advanced Solid Tumors Uveal Melanoma
Interventions Phase 1b: APG-115+pembrolizumab
Updated 28 times since 2018 Last updated: Aug 4, 2025 Started: Aug 29, 2018 Primary completion: Dec 30, 2025 Completion: Dec 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Cutaneous Melanoma and MDM2 Gene Mutation and is currently ongoing. Ascentage Pharma Group Inc. leads this study, which shows 28 recorded versions since 2018 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Sep 2018 – ~Jan 2019 · 4 months · monthly snapshot~Jan 2019 – ~Jan 2020 · 12 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshot~Mar 2023 – ~Mar 2024 · 12 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

28 versions recorded

  1. Sep 2025 — Present [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Sep 2024 — Sep 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

  4. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  5. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

▶ Show 23 earlier versions

  1. Mar 2023 — Mar 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Sep 2022 — Mar 2023 [monthly]

    Recruiting PHASE1_PHASE2

  3. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE1_PHASE2

  5. Apr 2022 — Jun 2022 [monthly]

    Recruiting PHASE1_PHASE2

  6. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE1_PHASE2

  7. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE1_PHASE2

  9. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE1_PHASE2

  10. Oct 2021 — Dec 2021 [monthly]

    Recruiting PHASE1_PHASE2

  11. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE1_PHASE2

  12. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE1_PHASE2

  13. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE1_PHASE2

  14. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE1_PHASE2

  15. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE1_PHASE2

  16. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE1_PHASE2

  17. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE1_PHASE2

  18. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE1_PHASE2

  19. May 2020 — Aug 2020 [monthly]

    Recruiting PHASE1_PHASE2

  20. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1_PHASE2

  21. Jan 2020 — Apr 2020 [monthly]

    Recruiting PHASE1_PHASE2

  22. Jan 2019 — Jan 2020 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  23. Sep 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Aug 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ascentage Pharma Group Inc.
  • Merck Sharp & Dohme LLC
Data source: Ascentage Pharma Group Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Bedford Park, Australia , Brisbane, Australia , Cincinnati, United States , Cleveland, United States , Durham, United States , Fairfax, United States , Fort Myers, United States , Heidelberg, Australia , Hershey, United States , Houston, United States and 11 more locations