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Clinical Trials in South Korea / NCT05061134
Active, not recruiting Phase 2

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

NCT05061134 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2022-08-11
Last updated
2025-07-31

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

Ceralasertib →Durvalumab →

Ceralasertib: Ceralasertib (240 mg) will be administered orally twice daily.

Durvalumab: Durvalumab (1500 mg) will be administered intravenously once every 28 days for participants who weight above \> 30 kgs. For participants who weigh below ≤ 30 kgs, weight-based dosing equivalent to 20 mg/kg of durvalumab will be administered.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * 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 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 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.

Primary outcome measure(s)

  • Main Study: Objective Response Rate (ORR) — Cycle 1 Day 1 (Each Cycle is 28 days) until objective disease progression or the last evaluable assessment in the absence of progression, or data cut-off (1 year 8 months)
    ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by Response Evaluation Criteria in Solid Tumours \[RECIST\] 1.1) that is confirmed at least 4 weeks later. As per planned in protocol, this outcome measure was assessed only for main study.
  • Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Center Tumor Region — Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
    Changes in CD8+ T-cell infiltration of tumours induced by ceralasertib monotherapy was assessed in baseline, on-treatment and off-treatment tumour biopsies As per planned in protocol, this outcome measure was assessed only for biopsy study.
  • Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Invasive Margin Region — Baseline, Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
    Changes in CD8+ T-cell infiltration of tumours induced by ceralasertib monotherapy was assessed in baseline and off-treatment tumour biopsies As per planned in protocol, this outcome measure was assessed only for biopsy study.
  • Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Center Tumor Region — Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
    Changes in CD8+ T-cell infiltration of tumours induced by ceralasertib monotherapy was assessed in baseline, on-treatment and off-treatment tumour biopsies As per planned in protocol, this outcome measure was assessed only for biopsy study.
  • Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Invasive Margin Region — Baseline, and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
    Changes in CD8+ T-cell infiltration of tumours induced by ceralasertib monotherapy was assessed in baseline and off-treatment tumour biopsies As per planned in protocol, this outcome measure was assessed only for biopsy study.

Trial sites (66)

FacilityCityRegionStatus
Research Site Los Angeles California
Research Site Sacramento California
Research Site San Francisco California
Research Site Tampa Florida
Research Site Lutherville-Timonium Maryland
Research Site Nashville Tennessee
Research Site Darlinghurst Australia
Research Site East Melbourne Australia
Research Site Herston Australia
Research Site Woolloongabba Australia
Research Site Belgium Belgium
Research Site Bruges Belgium
Research Site Ghent Belgium
Research Site Leuven Belgium
Research Site Edmonton Alberta
Research Site Toronto Ontario
Research Site Toronto Ontario
Research Site Ste-Foy Quebec
Research Site Bobigny France
Research Site Boulogne-Billancourt France
Research Site Marseille France
Research Site Paris France
Research Site Pau France
Research Site Pierre-Bénite France
Research Site Poitiers France
Research Site Vandœuvre-lès-Nancy France
Research Site Villejuif France
Research Site Berlin Germany
Research Site Buxtehude Germany
Research Site Heidelberg Germany
Research Site Heilbronn Germany
Research Site Kiel Germany
Research Site Mainz Germany
Research Site München Germany
Research Site Regensburg Germany
Research Site Schwerin Germany
Research Site Tübingen Germany
Research Site Candiolo Italy
Research Site Milan Italy
Research Site Naples Italy

+ 26 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) Recruiting
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer Recruiting
A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051) Recruiting
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma Active, not recruiting
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05061134 on ClinicalTrials.gov ↗ ← All trials in South Korea