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ATR Inhibitor

Ceralasertib + Olaparib/Durvalumab for Gynecological Cancers (ATARI Trial)

Phase 2
Recruiting
Led By Susana Banerjee
Research Sponsored by Institute of Cancer Research, United Kingdom
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ovarian and endometrial clear cell (>50% clear cell carcinoma with no serous differentiation)
Carcinosarcomas Note: patients who have an original diagnosis based on cytology only will not be eligible for entry into the study unless a biopsy confirming above histology is performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months)
Awards & highlights

Summary

This trial is testing a new drug called ceralasertib in patients with relapsed gynaecological cancers. The drug is being tested alone and in combination with other drugs to see how patients

Who is the study for?
This trial is for women with certain types of gynecological cancers (like ovarian, endometrial clear cell, and others) that have worsened after treatment. They must have a specific gene abnormality (ARID1A), measurable disease by scans, and be in good physical condition with a life expectancy over 16 weeks.
What is being tested?
The ATARI trial is testing the effectiveness of ceralasertib alone or combined with olaparib or durvalumab on patients whose cancer cells show ARID1A loss. It aims to see how well these drugs work based on the patient's cancer subtype.
What are the potential side effects?
Possible side effects include fatigue, nausea, skin reactions from immunotherapy (durvalumab), blood count changes from the ATR inhibitor (ceralasertib), and potential organ damage related to PARP inhibition (olaparib).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is mostly clear cell type without serous features.
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My cancer is confirmed as carcinosarcoma through a biopsy.
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My cancer has grown since my last cancer treatment.
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My physical ability has been stable or better for the last 2 weeks.
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I can provide a tissue sample from my diagnosis or relapse for testing.
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My cancer can be measured by scans and does not rely solely on CA125 levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until disease progression - estimated 6-9 months, up to max study period (36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Confirmed overall objective response rate (complete or partial response) as defined by RECIST version 1.1.
Secondary study objectives
Disease control rate
Duration of disease control
Overall Survival (OS)
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: 5: ceralasertib (AZD6738) + durvalumabExperimental Treatment2 Interventions
Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with NO loss of ARID1A.
Group II: 4: ceralasertib (AZD6738) + durvalumabExperimental Treatment2 Interventions
Women with endometrial cancers (serous, clear cell, endometroid, carcinosarcoma) with ARID1A loss.
Group III: 3: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions
Women with other rare relapsed gynaecological cancers (endometrioid ovarian carcinoma, endometrioid endometrial carcinoma, cervical adenocarcinoma, cervical squamous, ovarian carcinosarcoma and endometrial carcinosarcoma) irrespective of ARID1A status, treated with AZD6738 in combination with olaparib.
Group IV: 2: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions
Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with NO loss of ARID1A expression treated with AZD6738 in combination with olaparib.
Group V: 1B: ceralasertib (AZD6738) + olaparibExperimental Treatment2 Interventions
In second stage of trial, opening of this cohort depends on response rate in cohort 1A during first stage of trial. Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with loss of ARID1A expression treated with AZD6738 in combination with olaparib.
Group VI: 1A: ceralasertib (AZD6738)Experimental Treatment1 Intervention
Women with relapsed ovarian (fallopian tube / primary peritoneal) and endometrial (uterus) clear cell carcinomas with loss of ARID1A expression treated with single agent AZD6738.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~40
Durvalumab
2017
Completed Phase 2
~3840
Olaparib
FDA approved

Find a Location

Who is running the clinical trial?

Institute of Cancer Research, United KingdomLead Sponsor
161 Previous Clinical Trials
130,679 Total Patients Enrolled
Cancer Research UKOTHER
258 Previous Clinical Trials
4,434,952 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,635 Total Patients Enrolled
~41 spots leftby Apr 2026
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