Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I)
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|ClinicalTrials.gov Identifier: NCT05169957|
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : September 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Melanoma, Ocular Melanoma, Cutaneous Metastatic Melanoma Melanoma, Mucosal Liver Metastases||Drug: Ipilimumab Drug: Nivolumab Procedure: Stereotactic Body Radiation Therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I)|
|Actual Study Start Date :||August 9, 2022|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2024|
Experimental: Ipilimumab + Nivolumab + Stereotactic Body Radiation Therapy (SBRT)
Liver SBRT following the second cycle of ipilimumab + nivolumab, which will then be continued up to 4 total cycles prior to subsequent maintenance nivolumab for duration of clinical benefit and tolerance (standard of care systemic therapy)
Ipilimumab administered IV over 85-100 minutes at 3 mg/kg (combined with nivolumab administered IV over 30-60 minutes at 1 mg/kg) every 3 weeks for a total of 4 doses or until progression or unacceptable toxicity.
Nivolumab administered IV over 30-60 minutes at 1 mg/kg (combined with ipilimumab administered IV over 85-100 minutes at 3 mg/kg) every 3 weeks for a total of 4 doses of the combination therapy or until progression or unacceptable toxicity. Subjects may receive maintenance dosing of nivolumab alone administered IV over 30-60 minutes at 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 52 weeks or until progression or unacceptable toxicity.
Procedure: Stereotactic Body Radiation Therapy
24-45 Gy delivered in three fractions to up to 4 liver metastases
Other Name: SBRT
- Percentage of patients who receive all planned radiotherapy. [ Time Frame: Up to 5 weeks after start of study treatment ]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)
- Proportion of patients who develop grade 3 or higher toxicity [ Time Frame: Up to 14 weeks after start of study treatment ]Proportion of patients who develop grade three or higher toxicities within 60 days after treatment with SBRT or thirty days after the last cycle of I/N, whichever occurs later. Any serious adverse event that occurs after this time frame and is considered related to the study treatment will also be reported.
- Overall survival (OS) [ Time Frame: Up to 2 years after end of study treatment ]OS defined as the time from start of treatment to death. This will be analyzed using Kaplan-Meier curves and descriptive statistics.
- Progression free-survival (PFS) [ Time Frame: Up to 2 years after end of study treatment ]PFS defined as the time from start of treatment to date of radiological or clinical progression (leading to withdrawal from the study), or death from any cause, whichever comes first. Assessed Per RECIST v1.1; analyzed using Kaplan-Meier curves and descriptive statistics.
- Proportion of patients with local control [ Time Frame: Up to 2 years after end of study treatment ]Freedom from local progression (local control) is defined as the lack of progression of the tumors treated by RT, either by tumor size or enhancement. Progression or development of new tumors elsewhere in the liver or outside of the liver would not constitute a local control failure. Tumors which increase in size or demonstrate new or increasing enhancement are considered progression. Analyzed using Kaplan-Meier curves and descriptive statistics.
- Objective response rate (ORR) [ Time Frame: Up to 2 years after end of study treatment ]The percentage of patients whose disease decreases (Partial response - PR) and/or disappears (Complete response - CR) after treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Best overall response (BoR) [ Time Frame: Up to 2 years after end of study treatment ]The best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169957
|United States, Michigan|
|University of Michigan Rogel Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Radiation Oncology 734-936-4300 CancerAnswerLine@med.umich.edu|
|Principal Investigator: Michael D. Green, MD, PhD|
|Principal Investigator:||Michael D. Green, MD, PhD||University of Michigan Rogel Cancer Center|