A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

• Status: Not yet recruiting
• Trial end date: 2023-12-18
• Target enrollment: 0
• Participant gender: All

Summary

Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab

Criteria

Inclusion Criteria:

• Participants must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype

• Availability of a fresh tumour biopsy taken at screening

• Patient must have received at least 1 prior immunotherapy (anti-PD-(L)1 ± anti-CTLA-4) for a minimum of 6 weeks

• 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, 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 Criteria:

• 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 organ transplant that requires use of immunosuppressive medications

• Inadequate bone marrow and impaired hepatic or renal function

• Known 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.