deltatrials
Recruiting PHASE2 INTERVENTIONAL 1-arm NCT05229614

Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease (ICONIC)

Immune Checkpoint Inhibitors and Carbon iON Radiotherapy In Solid Cancers With Stable Disease

Sponsor: CNAO National Center of Oncological Hadrontherapy

Updated 8 times since 2022 Last updated: Aug 20, 2024 Started: Jul 26, 2022 Primary completion: Aug 31, 2025 Completion: Aug 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05229614, this PHASE2 trial focuses on Head and Neck Squamous Cell Carcinoma and Melanoma and remains actively recruiting participants. Sponsored by CNAO National Center of Oncological Hadrontherapy, it has been updated 8 times since 2022, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

This is a multicenter, open label, non-randomized phase II clinical trial aiming to assess the feasibility and the clinical activity of adding CIRT to ICIs in cancer patients that have obtained a disease stability (SD) with pembrolizumab administered as per standard of care. At study entry, hypofractionated CIRT will be delivered to one measurable lesion previously untreated with local approaches.CIRT will be performed at Fondazione CNAO, Pavia

This is a multicenter, open label, non-randomized phase II clinical trial aiming to assess the feasibility and the clinical activity of adding CIRT to ICIs in cancer patients that have obtained a disease stability (SD) with pembrolizumab administered as per standard of care. At study entry, hypofractionated CIRT will be delivered to one measurable lesion previously untreated with local approaches.CIRT will be performed at Fondazione CNAO, Pavia

Status Flow

~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2022 – ~Mar 2023 · 11 months · monthly snapshotNot Yet Recruiting~Mar 2023 – ~Jun 2023 · 3 months · monthly snapshotRecruiting~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotRecruiting~Sep 2025 – present · 7 months · monthly snapshotRecruiting~Jan 2026 – present · 3 months · monthly snapshotRecruiting

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Recruiting PHASE2

  2. Sep 2025 — Present [monthly]

    Recruiting PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. Jun 2023 — Jul 2024 [monthly]

    Recruiting PHASE2

Show 3 earlier versions
  1. Mar 2023 — Jun 2023 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  2. Apr 2022 — Mar 2023 [monthly]

    Not Yet Recruiting PHASE2

  3. Mar 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • CNAO National Center of Oncological Hadrontherapy
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
  • Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  • GSI Helmholtzzentrum für Schwerionenforschung GmbH, Darmstadt, Germany
Data source: CNAO National Center of Oncological Hadrontherapy

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