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Protein Kinase Inhibitor

Ceralasertib + Durvalumab for Melanoma (MONETTE Trial)

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until death (approx. up to 2 years)
Awards & highlights

MONETTE Trial Summary

This trial is testing a new drug for people with melanoma that has spread or can't be removed surgically, and who have already tried a different kind of treatment.

Who is the study for?
This trial is for adults with advanced melanoma that hasn't responded to PD-(L)1 inhibitors. They should have tried immunotherapy, be expected to live at least 3 more months, and agree to tumor biopsies. People can't join if they've had severe side effects from previous cancer treatments, organ transplants requiring drugs that suppress the immune system, certain heart conditions or infections.Check my eligibility
What is being tested?
The study tests Ceralasertib alone and combined with Durvalumab in patients whose melanoma resisted prior treatment with PD-(L)1 blockers. It's an open-label phase 2 trial aiming to see how well these treatments work and their safety.See study design
What are the potential side effects?
Ceralasertib may cause blood cell count changes, liver enzyme alterations leading to potential liver damage, fatigue, nausea and rash. Durvalumab might lead to immune-related issues affecting organs like lungs or intestines (pneumonitis or colitis), skin problems (rash), hormone gland disorders (thyroid issues), and infusion reactions.

MONETTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My melanoma cannot be removed by surgery and is of a specific type (skin, acral, or mucosal).
Select...
I've had 1-2 treatments with specific immune therapies for my advanced cancer and it has progressed despite these treatments.

MONETTE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until death (approx. up to 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until death (approx. up to 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy sub-study: CD8+ T-cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies
Main study: Objective response rate (ORR)
Secondary outcome measures
Biopsy sub-study: Assessment of proliferation of carcinoma in Ki67 marker (Marker Of Proliferation Ki-67) or CD8+ T cells immune cells
Biopsy sub-study: ORR
Biopsy sub-study: Pre-treatment presence and/or on-treatment and/or off-treatment changes in PD-L1 and pRAD50
+7 more

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

MONETTE Trial Design

4Treatment groups
Experimental Treatment
Group I: Main study: Ceralasertib + DurvalumabExperimental Treatment2 Interventions
Participants will receive ceralasertib on Days 1 to 7 plus durvalumab Day 8, once in 28 days (Q28D), until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met.
Group II: Main study: CeralasertibExperimental Treatment1 Intervention
Participants will receive ceralasertib on Days 1 to 7, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met.
Group III: Biopsy study: CeralasertibExperimental Treatment1 Intervention
During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28.
Group IV: Biopsy Sub-study: Ceralasertib + DurvalumabExperimental Treatment2 Interventions
From Cycle 1, participants will receive combination of ceralasertib twice daily (BD) Days 1 to 7 plus durvalumab Day 8, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or a study treatment discontinuation criterion is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,592 Total Patients Enrolled
19 Trials studying Melanoma
2,514 Patients Enrolled for Melanoma

Media Library

Ceralasertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05061134 — Phase 2
Melanoma Research Study Groups: Main study: Ceralasertib + Durvalumab, Main study: Ceralasertib, Biopsy Sub-study: Ceralasertib + Durvalumab, Biopsy study: Ceralasertib
Melanoma Clinical Trial 2023: Ceralasertib Highlights & Side Effects. Trial Name: NCT05061134 — Phase 2
Ceralasertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061134 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled in this experiment at this time?

"The study is still open and recruiting patients, as seen on clinicaltrials.gov. This trial was initially posted on 8/11/2022 and was most recently updated on 10/21/2022."

Answered by AI

Could you please explain the risks associated with Ceralasertib?

"Ceralasertib is still being tested for efficacy in Phase 2 trials, but there is some data supporting its safety--we've given it a score of 2."

Answered by AI

Does this research project restrict its participants to people under a certain age?

"This study is looking for patients aged 18 to 130. In contrast, 60 trials focus on individuals younger than 18 while 1121 are geared towards people over the age of 65."

Answered by AI

How do I sign up for this clinical trial?

"This clinical trial is looking for 195 patients that have been diagnosed with melanoma. The study has specific age, treatment, and health requirements that potential participants must meet in order to be eligible. Some of these include being 18 years or older, having received immunotherapy in the past, and having a life expectancy of at least 3 months from the proposed start date of the trial. If you think you may qualify and are interested in participating, please reach out to the research team for more information."

Answered by AI

In how many different hospitals is this study being run today?

"There are 11 sites where this study is enrolling patients. To help participants, they have chosen locations in Sacramento, Toronto and San Francisco as well as other cities to make it more convenient."

Answered by AI

What are some other examples of Ceralasertib being studied in a medical capacity?

"There are presently 353 Ceralasertib clinical trials underway. Of these, 51 have progressed to Phase 3 testing. Although the majority of these studies are based in Cordoba and Texas, there are a total of 13157 locations running trials for this treatment worldwide."

Answered by AI

How many people are enrolling in this research project?

"Yes, the data available on clinicaltrials.gov affirms that this trial is still recruiting patients. This research was first made public on August 11th, 2022 and has since been updated on October 21st, 2022. So far, 195 individuals have been accepted across 11 sites."

Answered by AI

What are the primary goals of this clinical trial?

"The purpose of this ongoing clinical trial is to observe the Main study's ORR (objective response rate) and the Biopsy sub-study's changes in PD-L1 and pRAD50 (tumour tissue samples that change following exposure to ceralasertib). The trial length is 28 days per cycle."

Answered by AI

What are Ceralasertib's most popular applications?

"Ceralasertib is commonly used to treat unresectable stage iii non-small cell lung cancer. This drug can also be effective in treating other conditions, such as previously untreated metastatic ureter urothelial carcinoma and advance directives."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
2022. "A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061134.
~73 spots leftby Apr 2025
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