Ceralasertib for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Melanoma
Ceralasertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: From screening until death (approx. up to 2 years)

Year 2
Main study: Objective response rate (ORR)
Year 2
Biopsy sub-study: ORR
Biopsy study: Screening, on-treatment and off-treatment during Cycle 1
Biopsy sub-study: Pre-treatment presence and/or on-treatment and/or off-treatment changes in PD-L1 and pRAD50
Day 28
Main study: Concentration of ceralasertib in plasma
Year 2
Biopsy sub-study: Assessment of proliferation of carcinoma in Ki67 marker (Marker Of Proliferation Ki-67) or CD8+ T cells immune cells
Year 2
Main study and Biopsy sub-study: Overall survival (OS)
Year 1
Main study and Biopsy sub-study: Progression free survival (PFS)
Year 1
Main study and Biopsy sub-study: Number of adverse events and serious adverse events
Week 20
Main study and Biopsy sub-study: Percentage change in target lesion tumour size
Year 2
Main study and Biopsy sub-study: Duration of Response (DoR)
Main study and Biopsy sub-study: Time to objective response (TTR)
Screening, on-treatment and off-treatment during Cycle 1
Biopsy sub-study: CD8+ T cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies
Biopsy sub-study: CD8+ T-cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Durvalumab and Tremelimumab
38%Fatigue
21%Diarrhea
17%Maculopapular rash
17%Fever
17%Pruritus
17%Nausea
17%Anorexia
14%Rash maculo-papular
14%Constipation
10%Itching
10%Abdominal pain
10%Anemia
7%Weight loss
7%Dehydration
7%Cough
7%Dry Skin
7%Hypothyroidism
7%Non-cardiac chest pain
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03007407) in the Durvalumab and Tremelimumab ARM group. Side effects include: Fatigue with 38%, Diarrhea with 21%, Maculopapular rash with 17%, Fever with 17%, Pruritus with 17%.

Trial Design

4 Treatment Groups

Main study: Ceralasertib
1 of 4
Main study: Ceralasertib + Durvalumab
1 of 4
Biopsy Sub-study: Ceralasertib + Durvalumab
1 of 4
Biopsy study: Ceralasertib
1 of 4

Experimental Treatment

195 Total Participants · 4 Treatment Groups

Primary Treatment: Ceralasertib · No Placebo Group · Phase 2

Main study: Ceralasertib
Drug
Experimental Group · 1 Intervention: Ceralasertib · Intervention Types: Drug
Main study: Ceralasertib + DurvalumabExperimental Group · 2 Interventions: Ceralasertib, Durvalumab · Intervention Types: Drug, Biological
Biopsy Sub-study: Ceralasertib + DurvalumabExperimental Group · 2 Interventions: Ceralasertib, Durvalumab · Intervention Types: Drug, Biological
Biopsy study: Ceralasertib
Drug
Experimental Group · 1 Intervention: Ceralasertib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
Not yet FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening until death (approx. up to 2 years)

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,962 Previous Clinical Trials
91,810,539 Total Patients Enrolled
19 Trials studying Melanoma
2,797 Patients Enrolled for Melanoma

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a tumour sample from an archival or frozen tissue block and a fresh tumour biopsy taken at screening.
You have measurable disease by RECIST 1.1.\n
You are willing to have 3 tumour biopsies taken.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.