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

  • STATUS
    Recruiting
  • End date
    Aug 23, 2024
  • participants needed
    18
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 7 October 2022

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.

Details
Condition Melanoma, Ocular, Melanoma, Cutaneous, Metastatic Melanoma, Melanoma, Mucosal, Liver Metastases
Treatment Ipilimumab, Nivolumab, stereotactic body radiation therapy
Clinical Study IdentifierNCT05169957
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (≥18 years of age) with histologically or cytologically confirmed metastatic melanoma that is unresectable with liver metastases; disease must be measurable per RECIST criteria
Patients must have a life expectancy of at least 6 months
Patients must have a performance status of 0 - 2 on the ECOG Performance Scale
Allowable prior therapy
Previous adjuvant or neoadjuvant treatment for melanoma is allowed, which may include molecularly-targeted agents, IFN-alpha, ipilimumab, nivolumab, and pembrolizumab, if it was completed at least 6 weeks before enrollment in the study
Patients who had experienced treatment-related adverse events from prior adjuvant or neoadjuvant treatment for melanoma are allowed if symptoms had returned to baseline or had stabilized
Prior stereotactic radiotherapy (SBRT) of extrahepatic metastases is permitted
Patients must be willing to undergo multiple liver tissue samplings and samples should
be of adequate quality for correlative studies
Patients must have adequate organ function per protocol
Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks
Participants of childbearing potential
Female subject of childbearing potential should have a serum pregnancy within 14 days of enrollment and 72 hours prior to receiving the first dose of I/N, and must be willing to use a highly effective method of contraception for the course of the study through 180 days after the last dose of I/N. (Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.)
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 180 days after the last dose of study therapy. Sperm donation is prohibited while on study. (Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.)

Exclusion Criteria

Patients will be excluded from the trial if participants have the following
Diffuse involvement of liver by cancer on CT, PET, or MRI imaging
More than 4 liver metastases on CT scan at time of initial assessment. If a flare occurs during the initial I/N cycles, up to 8 metastases may be targeted if able to be targeted by a minimum of 8 Gy per fraction while meeting normal tissue constraints
Diagnosis of underlying parenchymal end stage liver disease (cirrhosis) or biliary disease (primary biliary cirrhosis)
Other invasive malignancy active within last 3 years, excluding in situ cancers
Patients who had received previous systemic anticancer therapy for unresectable or metastatic melanoma
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least two weeks prior to enrollment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to enrollment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
Has active autoimmune disease that has required systemic treatment within the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
• Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic
corticosteroid replacement therapy for adrenal or pituitary insufficiency
etc.) is not considered a form of systemic treatment
Require daily corticosteroids >10 mg of prednisone (or its equivalent)
Note: Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would NOT be excluded from the study
Note: Patients who require the use of topical steroids would not be excluded
Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with informed consent through 180 days after the last dose of trial treatment
Has a diagnosis of immunodeficiency (including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency (AIDS)-related illness) or has received a bone marrow transplant or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment
Has a known history of active TB (Bacillus Tuberculosis)
Has known active Hepatitis B or Hepatitis C
Prior Gr3/4 life threatening immune related adverse event that is considered an unacceptable risk per the treating investigator
Has received a live vaccine within 30 days of enrollment
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
COVID vaccination acceptable; preferably all doses administered 7 days prior to start of therapy
Lacks insurance preapproval for SBRT
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