A Study of Ceralasertib Monotherapy and Ceralasertib plus Durvalumab in Patients with Melanoma and Resistance to PD-(L)1 Inhibition - MONETTE

Study identifier:D533AC00001

ClinicalTrials.gov identifier:NCT05061134

EudraCT identifier:2021-001722-21

CTIS identifier:N/A

Recruitment Complete

Official 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

Medical condition

Melanoma

Phase

Phase 2

Healthy volunteers

No

Study drug

Ceralasertib

Sex

All

Actual Enrollment

194

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 11 Aug 2022
Primary Completion Date: 12 Apr 2024
Estimated Study Completion Date: 30 Jun 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria