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.
Eligible Conditions
- Metastatic Melanoma
- Mucosal Melanoma
- Skin Cancer (Melanoma)
- Liver Metastases
- Eye Melanoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Up to 5 weeks after start of study treatment
Week 14
Proportion of patients who develop grade 3 or higher toxicity
Year 2
Best overall response (BoR)
Objective response rate (ORR)
Overall survival (OS)
Progression free-survival (PFS)
Proportion of patients with local control
Week 5
Percentage of patients who receive all planned radiotherapy.
Trial Safety
Safety Progress
Side Effects for
Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
55%Leukopenia
36%Lymphopenia
36%Thrombocytopenia
18%AST elevation
18%Reduced ANC
18%ALT elevation
18%Anemia
9%Pneumonia
9%Depression
9%Hyperkalemia
9%Vomiting
9%Nausea
9%Hypokalemia
9%Urinary tract infection
9%Orthostasis
9%Dehydration
9%Sepsis
9%Sinusitis
9%Pancreatitis
9%Acidosis
9%Rash
9%Cardiac disorders
9%Pleural effusion
9%Somnolence
Trial Design
1 Treatment Group
Ipilimumab + Nivolumab + Stereotactic Body Radiation Therapy (SBRT)
1 of 1
Experimental Treatment
18 Total Participants · 1 Treatment Group
Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · Phase 1
Ipilimumab + Nivolumab + Stereotactic Body Radiation Therapy (SBRT)Experimental Group · 3 Interventions: Stereotactic Body Radiation Therapy, Nivolumab, Ipilimumab · Intervention Types: Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~600
Nivolumab
FDA approved
Ipilimumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 weeks after start of study treatment
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
267 Previous Clinical Trials
18,113 Total Patients Enrolled
1 Trials studying Metastatic Melanoma
4 Patients Enrolled for Metastatic Melanoma
Michael D. Green, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:In order for patients to be eligible for the liver tissue biomarker study, they must be willing to have multiple tissue samplings
Participants who have received prior adjuvant or neoadjuvant treatment for melanoma are allowed to enroll in the study, as long as that treatment was completed at least 6 weeks prior to enrolling in the study
Patients who have had treatment-related adverse events from previous treatments for melanoma are allowed if their symptoms have returned to normal or if they have stabilized.
who are receiving RIVRON-6
The participants of childbearing potential who are receiving RIVRON-6 are at a higher risk of experiencing severe side effects.
Patients must have a good performance status on the ECOG Performance Scale, which is a scale from 0 to 2 where 0 is the best and 2 is the worst.
Previously, stereotactic radiotherapy of extrahepatic metastases was allowed.
Patients must have adequate organ function in order to meet the requirements of the protocol.
Before enrolling in the study, patients must sign an informed consent form that explains the study, its risks and benefits, and that they understand they are voluntarily taking part in the study.
This is an announcement for people who are 18 years or older who have metastatic melanoma which is not able to be surgically removed and has spread to the liver
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Conditions
Cancer Related
Treatments