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Closed (no longer recruiting)Last updated: 21 December 2023

CA184-325: This phase I/II trial is combining ipilimumab and radiotherapy for the treatment of metastatic melanomaRadiotherapy and Ipilimumab in Metastatic Melanoma

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 patients with Melanoma.

Cancer

Skin Cancers Skin

Age

People18 - 75

Phase

I/II

Trial Acronym

CA184-325

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

Radiotherapy and Ipilimumab in Metastatic 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.

Exclusion

1.Symptomatic brain metastases or those treated < 3 months previously
2.Patients requiring RT to brain, or chest and abdomen where it is expected that viscera will be in field
3.Patients being recommended a higher dose of RT (e.g. 30Gy/10#)
4.Taking immunosuppressive doses of corticosteroids (>5mg of prednisolone or equivalent) or other immunosuppressant medications
5.Previous treatment with Ipilimumab, nivolumab or Pembrolizumab
6.Previous other investigational products within last 4 weeks
7.Uncontrolled infectious diseases (HIV, Hepatitis B etc)
8.Autoimmune disease (including, but not limited to Crohn’s Disease, Ulcerative Colitis, Rheumatoid Arthritis etc)
9.Prior malignancy active within the previous 3 years, except for locally curable cancers
that have been apparently cured, such as basal or squamous cell skin cancer,
superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
10. Prior allogenic stem cell transplant
11. History of immunodeficiency

Inclusion

  • Your cancer has spread to other parts of the body.

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 have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.