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Checkpoint Inhibitor
Radiation + Immunotherapy for Melanoma with Liver Metastases
Phase 1
Recruiting
Led By Michael D. Green, MD, PhD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks after start of study treatment
Awards & highlights
Study Summary
This trial is testing a new treatment for metastatic melanoma that has spread to the liver. The treatment is a combination of radiation and two immunotherapy drugs. The goal is to see if this new treatment is effective and tolerated by patients.
Who is the study for?
This trial is for adults with metastatic melanoma that's spread to the liver and can't be removed by surgery. Participants must have a life expectancy of at least 6 months, good organ function, and not be pregnant or breastfeeding. They should agree to use effective contraception and not have had certain treatments recently. People with severe liver disease, active hepatitis B or C, more than 4 liver metastases initially (up to 8 after treatment), other cancers in the last 3 years, untreated brain metastases, serious autoimmune diseases requiring treatment in the past two years, HIV/AIDS-related illness or are on high-dose steroids cannot join.Check my eligibility
What is being tested?
The HAMMER I trial tests if combining stereotactic body radiation therapy (SBRT) targeting liver tumors with systemic immunotherapy drugs nivolumab and ipilimumab improves outcomes for patients. The goal is to see if this approach helps those who might not benefit from just systemic therapy.See study design
What are the potential side effects?
Possible side effects include immune system reactions leading to inflammation in various organs like the intestines or lungs (colitis or pneumonitis), skin rash, hormone gland problems (like thyroid issues), fatigue, flu-like symptoms and potential risks associated with radiation such as localized pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I had treatment for melanoma that ended at least 6 weeks ago.
Select...
I am willing to have multiple liver biopsies.
Select...
I am an adult with advanced melanoma that has spread to my liver and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 weeks after start of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks after start of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients who receive all planned radiotherapy.
Secondary outcome measures
Best overall response (BoR)
Objective response rate (ORR)
Overall survival (OS)
+3 moreSide effects data
From 2022 Phase 2 trial • 29 Patients • NCT0204544679%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Chest pain
21%
Anorexia
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Creatinine increased
7%
Otitis externa
7%
Dehydration
7%
Sinusitis
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Blurred vision
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Hypertension
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ipilimumab + Nivolumab + Stereotactic Body Radiation Therapy (SBRT)Experimental Treatment3 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,103 Total Patients Enrolled
1 Trials studying Melanoma
4 Patients Enrolled for Melanoma
Michael D. Green, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active Hepatitis B or C infection.I have had targeted radiation for cancer spread outside the liver.I need more than 10 mg of prednisone or similar medication daily.I have an active tuberculosis infection.I have an autoimmune disease treated with strong medication in the last 2 years.My liver has more than 4 cancer spots, but less than 9, that can be treated with radiation.I can take care of myself and am up and about more than half of my waking hours.I am willing to sign a consent form understanding the risks of this study.I had treatment for melanoma that ended at least 6 weeks ago.I have an immunodeficiency, HIV/AIDS, had a bone marrow transplant, or took immunosuppressants recently.I do not have active cancer in the lining of my brain and spinal cord.I have had treatment for melanoma that couldn't be removed by surgery.I have been diagnosed with advanced liver disease.I haven't had any other advanced cancers except for treated localized ones in the past 3 years.I had side effects from previous melanoma treatment, but they have stabilized or returned to normal.I am willing to have multiple liver biopsies.My organs are functioning well.I have not received a live vaccine in the last 30 days.I had a severe reaction to previous immune therapy that my doctor considers too risky.I am an adult with advanced melanoma that has spread to my liver and cannot be removed by surgery.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ipilimumab + Nivolumab + Stereotactic Body Radiation Therapy (SBRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still going on for this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that the trial, initiated on August 9th 2022, is currently seeking new participants. 18 patients are needed to be enrolled at one medical centre."
Answered by AI
How many participants have enrolled in this trial thus far?
"That is affirmative. According to clinicaltrials.gov, this trial, which was first listed on August 9th 2022, is actively recruiting participants at present. Only eighteen individuals have to be recruited from a single medical center."
Answered by AI
In what cases is the application of Stereotactic Body Radiation Therapy usually recommended?
"Stereotactic Body Radiation Therapy is a common treatment for anti-angiogenic therapy and has been seen to be efficacious in treating malignant neoplasms, unresectable melanoma, squamous cell carcinomas, and more."
Answered by AI
Has the FDA sanctioned Stereotactic Body Radiation Therapy?
"There is limited data regarding the safety and efficacy of Stereotactic Body Radiation Therapy, thus it received a rating of 1."
Answered by AI
What have been the other findings that have utilized Stereotactic Body Radiation Therapy?
"Currently, 764 clinical trials are being conducted on Stereotactic Body Radiation Therapy. Of those studies, 86 have entered Phase 3 of the trial process. Primarily based in Pittsburgh, Pennsylvania, a total of 42751 different sites around the world are running this type of research."
Answered by AI
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