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A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib plus Durvalumab in Patients with Unresectable or Advanced Melanoma
EU CTIS ID: 2024-512378-91-00
What this study is testing
To estimate the effectiveness of ceralasertib monotherapy and ceralasertib plus durvalumab by assessment of objective response rate (ORR) in patients with unresectable or advanced melanoma and primary or secondary resistance to a PD-(L)1 inhibitor. Biopsy Sub-Study: To assess changes in CD8+ T cell infiltration of tumours induced by ceralasertib monotherapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype
- Biopsy Sub-Study: Lesions used for biopsy may have received prior radiation therapy only if there is documented evidence of progression in the lesion after radiation treatment
- Availability of an archival tumour sample and 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 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.
- No intervening treatment eg, investigational therapy is permitted between the anti-PD-(L)1 therapy and study treatment
- BRAF V600E or V600K mutation status must be known at screening
You likely can't join if
- Patients must not have experienced a toxicity that led to permanent discontinuation of prior CPI treatment.
- 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
- 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.
- Active or prior documented autoimmune or inflammatory disorders (including, but not limited to inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, irritable bowel disease, Wegner syndrome, Hashimoto syndrome, hyperthyroidism, Sjogren's syndrome, glomerulonephritis, multiple sclerosis, vasculitis, heumatoid arthritis, idiopathic pulmonary fibrosis, pneumonitis, organising pneumonia, hepatitis, sarcoidosis, active tuberculosis) within the past 3 years
- Inadequate bone marrow and impaired hepatic or renal function.
See the full eligibility criteria
- Patient must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype
- Biopsy Sub-Study: Lesions used for biopsy may have received prior radiation therapy only if there is documented evidence of progression in the lesion after radiation treatment
- Availability of an archival tumour sample and 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 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.
- No intervening treatment eg, investigational therapy is permitted between the anti-PD-(L)1 therapy and study treatment
- BRAF V600E or V600K mutation status must be known at screening
- Measurable disease by RECIST 1.1.
- Biopsy Sub-Study: Consent to the provision of 3 mandatory tumour biopsies.
- Biopsy Sub-Study: Have at least 1 tumour lesion medically accessible for 3 biopsies at baseline, on ceralasertib treatment and off ceralasertib treatment. Accessible lesions are defined as tumour lesions which are amenable to biopsy, unless clinically contraindicated or the patient has withdrawn consent. It is preferable that the same lesion is used for each biopsy, but if this is not possible, a patient may enrol if they have more than 1 lesion that is suitable for biopsy from the same tissue type eg, 3 cutaneous lesions
- Biopsy Sub-Study: Lesions used for biopsy should be different from those used as RECIST lesions, unless there are no other lesions suitable for biopsy
- Patients must not have experienced a toxicity that led to permanent discontinuation of prior CPI treatment.
- 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
- 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.
- Active or prior documented autoimmune or inflammatory disorders (including, but not limited to inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], celiac disease, irritable bowel disease, Wegner syndrome, Hashimoto syndrome, hyperthyroidism, Sjogren's syndrome, glomerulonephritis, multiple sclerosis, vasculitis, heumatoid arthritis, idiopathic pulmonary fibrosis, pneumonitis, organising pneumonia, hepatitis, sarcoidosis, active tuberculosis) within the past 3 years
- Inadequate bone marrow and impaired hepatic or renal function.
- Biopsy Sub-Study: Patients must comply with the exclusion criteria described for the main study
- Biopsy Sub-Study: Patients with evidence of bleeding disease deemed unsafe for serial biopsies
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Australia
- Korea, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Australia; Korea, Republic of; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.