Ceralasertib + Durvalumab for Melanoma
(MONETTE Trial)

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

You have a disease that can be measured according to a specific standard.

I can provide both an old and a new sample of my tumor.

It has been at least 14 days since my last dose of anti-PD-(L)1 or BRAF/MEK inhibitor.

+4 more

Exclusion Criteria

I have had an organ transplant and take drugs to suppress my immune system.

I have never stopped a CPI treatment due to severe side effects.

I do not have serious heart problems like heart failure, unstable chest pain, or dangerous irregular heartbeats.

+6 more

Participant Groups

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.

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.