MONETTE: 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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Primary Or Secondary Resistance To Pd-(l)1 Inhibition
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patients must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype. 2) Availability of a fresh tumour biopsy taken at screening, if medically feasible as per investigator assessment. 3) Patients must have received at least 1 prior immunotherapy (anti-PD-(L)1 ± anti-CTLA-4) for a minimum of 6 weeks. 4) Patients must have confirmed progression during treatment with a PD-(L)1 inhibitor +/- a CTLA 4 inhibitor, eg, nivolumab, pembrolizumab, or atezolizumab, or the combination of nivolumab and ipilimumab.

You may not be eligible for this study if the following are true:

  • 1) Patients with unresolved = Grade 2 toxicity from prior treatment or = Grade 1 for anti-PD-(L)1 antibody-related immune-mediated toxicities. 2) Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diseases, active infection, active interstitial lung disease/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations), history of allogenic organ transplant. 3) Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow a formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment. 4) 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 and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy or adequately treated carcinoma in situ without evidence of disease.

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