Trial purpose
Cancer treatment
Tumor type
Skin
Age
18 - 130
Clinical summary
Summary
This study has two parts: a Main Study and a Biospy Sub-Study. The Main Study has has two Experimental Arms that participants will be randomly allocated to. In Experimental Arm A, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7 plus durvalumab (1500mg, intravenously once every 28 days for those weighing more than 30kgs or at a weight-based dosing for those 30kgs or lighter) once in 28 days (Q28D). In Experimental Arm B, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7, Q28D. The Biopsy Sub-Study is enrolling participants suitable for 3 mandatory biopsies. Serial tumour biopsies are mandated in participants recruited into the sub-study and will be taken at baseline during the screening period, during treatment with ceralasertib monotherapy and during the off-treatment period of ceralasertib monotherapy. The Biopsy Sub-Study has two experimental arms, that involve the same treatment as the Main Study (described above).
Conditions
This trial is treating people with melanoma
Eligibility
Inclusion
- Participants must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype
- Availability of an archival tumour sample and a fresh tumour biopsy taken at screening
- Patient must have received at least 1 prior immunotherapy (anti-PD-(L)1 ± anti-CTLA-4 [Cytotoxic T-lymphocyte-associated protein 4]) for a minimum of 6 weeks and no more than 2 prior regimens in the metastatic setting. Patients must have confirmed progression during treatment with a PD-(L)1 inhibitor +/- a CTLA-4 inhibitor.
- The interval between the last dose of anti-PD-(L)1, BRAF/MEK (B-Rapidly Accelerated Fibrosarcoma gene/mitogen-activated protein kinase gene) inhibitor and the first dose of the study regimen must be a minimum of 14 days
- Measurable disease by RECIST 1.1.
- Patients must have a life expectancy ≥3 months from proposed first dose date.
- Biopsy Sub-study: Consent to the provision of 3 mandatory tumour biopsies.
Exclusion
- Patients must not have experienced a toxicity that led to permanent discontinuation of prior checkpoint inhibitors (CPI) treatment.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 3 years before the first dose of study treatment
- Uveal melanoma
- Must not have experienced a Grade ≥ 3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy
- History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the study clinical lead.
- History of organ transplant that requires use of immunosuppressive medications
- Inadequate bone marrow and impaired hepatic or renal function
- Known active infection requiring systemic therapy, active hepatitis infection, positive hepatitis C virus antibody, hepatitis B virus (HBV) surface antigen or HBV core antibody (anti-HBc), at screening
- Patients with confirmed COVID-19 infection by polymearse chain reaction test who have not made a full recovery.
Inclusion
- You have had a certain type of treatment or surgical procedure.
- Your cancer has not spread to other parts of the body (localised).
- 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.
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 ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information