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NCT05169957 · ClinicalTrials.gov registry record · Phase 1

Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I)

A Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 1
Development phase
2
Enrollment target

NCT05169957: Completed Phase 1 study, sponsored by University of Michigan Rogel Cancer Center.

NCT05169957 is a Phase 1 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05169957, a Phase 1 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

The primary purpose of this study is to determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (ipilimumab and nivolumab) in adults with metastatic melanoma with liver metastases who are at significant risk of not benefiting from systemic therapy alone.

Primary Outcome

Percentage of patients who receive all fractions of radiotherapy as planned following the second cycle of ipilimumab/nivolumab (I/N). Radiotherapy will be administered on C2D8 of I/N (±7days)

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab
  • PROCEDURE Stereotactic Body Radiation Therapy

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2022-08-09
Est. Completion 2024-07-17
Phase Phase 1

What the finished NCT05169957 record still lists

NCT05169957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.

NCT05169957 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05169957 about?

NCT05169957 is a clinical study titled "Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I)". The primary purpose of this study is to determine the feasibility of liver stereotactic body radiation therapy (SBRT) given in combination with systemic therapy (ipilimumab and nivolumab) in adults with metastatic melanoma with liver metastases who are at significant risk of not benefiting from syst...

What is the current status of trial NCT05169957?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-08-09. Estimated completion is 2024-07-17.

What interventions are being tested in trial NCT05169957?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Stereotactic Body Radiation Therapy (PROCEDURE).

Who is sponsoring clinical trial NCT05169957?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05169957's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05169957, the US trial registry maintained by the National Library of Medicine. NCT05169957 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.