A study combining blood pressure medication with standard treatment in advanced melanoma. ACE-IT-001
- Conditions
- Melanoma - UnresectableMelanoma - MetastaticCancer - Malignant melanoma
- Registration Number
- ACTRN12621000156886
- Lead Sponsor
- Calvary Mater Newcastle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1.Male or Female subjects aged 18 years or over.
2.Written informed consent.
3.Willingness to comply with trial requirements
4.Eligible to receive Nivolumab and Ipilimumab checkpoint inhibitor as per local standard of care for the treatment of metastatic or unresectable melanoma who are treatment naïve.
5.Must not have received any prior systemic cancer therapies including but not limited to prior PD-1/PD-L1 or CTLA-4 checkpoint inhibitors. Patients who have received PD-1/PD-L1 or CTLA-4 inhibitors in the adjuvant or neo-adjuvant setting are eligible if it has been >6 months since the last dose of PD-1/PD-L1 therapy.
6.Adequate haematological function defined by:
oAbsolute neutrophil count equal to or greater that 1.0 x 109/L.
oPlatelet count equal to or greater than 80 x 109/L.
oHaemoglobin equal to or greater than 9g/dL – without prior transfusion within last 28 days.
7.Adequate hepatic function defined by:
o Total bilirubin level equal to or greater than 1.5 x ULN.
oAST and ALT levels equal to or greater than 2.5 x ULN unless liver metastases present then equal to or greater than 5 X ULN.
8.Adequate renal function defined by:
oEstimated creatinine clearance of greater than 40mL/min according to the Cockcroft-Gault formula.
9.Measurable disease as per RECIST 1.1 guidelines. Disease status before first treatment will be documented by contrast CT of the Chest, Abdomen, Pelvis and any known sites of disease. An MRI/CT Brain may be performed if clinically indicated at the discretion of the investigator. PET scans may be performed in addition to CT scans as per standard of care, but will not be used to assess response rates during the course of the study.
10.Presence of brain metastasis is acceptable if stability is demonstrated for at least 4 weeks prior to initiation of therapy.
11.ECOG performance status 0-2.
12.Autoimmune conditions must be stable for > 12 months prior to study entry and not require systemic immunosuppressive treatment. Topical steroid treatment for psoriasis will be allowed.
13.Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
14.Women must not be breastfeeding.
15.Women of childbearing potential (WOCBP) must agree to use effective contraception from the time informed consent is signed, the duration of the study and for 30 days after ceasing trial participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately.
16.Males who are sexually active with WOCBP must agree to use effective contraception for the duration of the study and for 30 days after ceasing trial participation.
1.Any known condition that in the opinion of the investigator will interfere with the study results or may inflict harm on the participant.
2.Known hypersensitivity to any of the prescribed treatments.
3.Any contraindication to perindopril that is deemed significant by the treating investigator.
4.Current use of anti-hypertensive, anti-coagulation or diuretic treatments.
5.Current regular use of NSAID’s within 30 days prior to treatment.
6.Vaccination within 28 days of the first treatment dose.
7.Prior Radiation treatment within 2 weeks of planned first dose of PD-1/PD-L1 therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the Incidence of treatment related adverse events of perindopril as lead in treatment and also in combination with Ipilimumab and Nivolumab using CTCAE v5[Daily for the duration of the treatment (up to 2 years) and up to 30 days after treatment cessation ]
- Secondary Outcome Measures
Name Time Method