InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 15 August 2023

MONETTE: This phase II study is evaluating how safe, tolerable and effective targeted therapy (ceralasertib) is alone, and in combination with immunotherapy (durvalumab), in people with inoperable or advanced melanoma and primary or secondary resistance to PD(L)1 InhibitionA 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

Clinical summary

Summary

This study has two parts: a Main Study and a Biospy Sub-Study. The Main Study has has two Experimental Arms that participants will be randomly allocated to. In Experimental Arm A, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7 plus durvalumab (1500mg, intravenously once every 28 days for those weighing more than 30kgs or at a weight-based dosing for those 30kgs or lighter) once in 28 days (Q28D). In Experimental Arm B, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7, Q28D. The Biopsy Sub-Study is enrolling 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. The Biopsy Sub-Study has two experimental arms, that involve the same treatment as the Main Study (described above).

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People18 - 130

Phase

II

Trial Acronym

MONETTE

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Commercial Sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.