Trial purpose
Cancer treatment
Tumor type
Skin
Age
18 - 75
Clinical summary
Summary
This study is examining the safety and biological effects of combining Ipilimumab and radiotherapy in patients with metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with advanced melanoma stage IIIc or IV. Trial details All participants in this trial will undergo 5 daily doses of radiotherapy during week 1. They will also receive Ipilimumab at a dose of either 3mg/kg or 10mg/kg at weeks 1, 4, 7, and 10. This drug will be administered intravenously (i.e. directly into the vein) over a period of 90 minutes. Participants will be reviewed for up to 24 months in order to determine treatment toxicities, tumour response, and immune response.
Conditions
This trial is treating people with Melanoma
Eligibility
Inclusion
1.Voluntarily signed and dated institutional ethics committee (IEC) approved informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before performing protocol-related procedures that are not part of standard patient care.
2.Able to comply with visits/procedures required by the protocol
3.Life expectancy of at least 3 months
4.> 18 years of age
5.Good performance status (ECOG 0-1)
6.Histologically proven advanced melanoma stage IIIC or IV
7.Measurable disease by modified RECIST 1.1 criteria (irradiated index lesion not included in overall response assessment).
8.Index lesion to be irradiated is measurable by RECIST 1.1 criteria
9.Index lesion to be irradiated is amenable to biopsy
10.Adequate hematologic, renal and liver function
11.Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception (using the clinicians’ discretion) to avoid pregnancy throughout the study and for up to 12 weeks after the last dose in such a manner that the risk of pregnancy is minimized.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Peter MacCallum Cancer Centre
Scientific Title
Radiotherapy and Ipilimumab in Metastatic Melanoma
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