A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT05061134
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Ceralasertib — DRUG
    Ceralasertib (240 mg) will be administered orally twice daily.
  • Durvalumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Aug 11, 2022
Status verified
Jul 2025
Primary completion
Apr 12, 2024
Completion
Nov 2, 2026

Study Design

Enrollment
194 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Main study: Ceralasertib + Durvalumab
    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.
  • Experimental: Main study: Ceralasertib
    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.
  • Experimental: Biopsy Sub-study: Ceralasertib + Durvalumab
    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.
  • Experimental: Biopsy study: Ceralasertib
    During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28.

Primary Outcome Measure

Main Study: Objective Response Rate (ORR) [ Time Frame: Cycle 1 Day 1 (Each Cycle is 28 days) until objective disease progression or the last evaluable assessment in the absence of progression, or data cut-off (1 year 8 months) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90024-
Research SiteSacramentoCalifornia95816-
Research SiteSan FranciscoCalifornia94143-
Research SiteTampaFlorida33612-
Research SiteLutherville-TimoniumMaryland21093-
Research SiteNashvilleTennessee37232-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Research Site· Los Angeles, CAResearch Site· Sacramento, CAResearch Site· San Francisco, CAResearch Site· Tampa, FLResearch Site· Lutherville-Timonium, MDResearch Site· Nashville, TN

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