Trials / Active Not Recruiting
Active Not RecruitingNCT05061134
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
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
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceralasertib | Ceralasertib (240 mg) will be administered orally twice daily. |
| BIOLOGICAL | Durvalumab | Durvalumab (1500 mg) will be administered intravenously once every 28 days for participants who weight above \> 30 kgs. For participants who weigh below ≤ 30 kgs, weight-based dosing equivalent to 20 mg/kg of durvalumab will be administered. |
Timeline
- Start date
- 2022-08-11
- Primary completion
- 2024-04-12
- Completion
- 2026-11-02
- First posted
- 2021-09-29
- Last updated
- 2025-07-31
- Results posted
- 2025-05-21
Locations
66 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05061134. Inclusion in this directory is not an endorsement.