Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Details

Biopsy sub-study: This is an open-label, non-randomised, sub-study planned in 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.

Keywords

Melanoma Unresectable or Advanced Melanoma Efficacy Safety Durvalumab Ceralasertib Biopsy Sub-study: Ceralasertib + Durvalumab Biopsy study: Ceralasertib

Eligibility

You can join if…

Open to people ages 18-130

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site
    San Francisco California 94143 United States
  • Research Site
    Sacramento California 95816 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05061134
Phase
Phase 2
Study Type
Interventional
Last Updated