Radiotherapy, Ipilimumab and Nivolumab in Metastatic Melanoma.
- Conditions
- MelanomaCancer - Malignant melanoma
- Registration Number
- ACTRN12613000385741
- Lead Sponsor
- Peter MacCallum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correction as this outcomes was assessed in both cohorts:<br>To establish a toxicity profile for patients receiving Ipilimumab and combination Ipilimumab + Nivolumab together with palliative radiotherapy.<br>[24 months];To assess the tumour response using CT scans and Response Evaluation Criteria in Solid Tumors (RECIST) V1.1[24 months];To assess for changes in immune response in the tumour lesions and peripheral blood. Pre and Post treatment biomarker levels will be taken from tumour biopsy's and peripheral blood. [24 months]
- Secondary Outcome Measures
Name Time Method To document progression free survival using CT scans and follow up appointments with physical exams.[24 months];To document overall survival using follow up appointments.[24 months];To document overall tumour response using CT scans. [24 months]