A Phase 4 interventional study of Durvalumab in Solid Tumor, sponsored by AstraZeneca. Completed at 116 sites in 31 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.
This is a multicenter, open-label, global study that will enroll patients who are currently receiving durvalumab monotherapy, or have previously received durvalumab as monotherapy or in combination with any other approved or investigational anticancer agents, in an eligible AstraZeneca/MedImmune-sponsored clinical study.
AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following exclusion criteria apply only to patients receiving treatment or retreatment:
Durvalumab Monotherapy
Drug: Durvalumab
Follow up Only
IV infusion q4w with 1500mg durvalumab until progressive disease
Also known as: MEDI4736
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above.
Time frame: From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months
Cohort 2: Overall Response Rate (ORR)
The ORR was defined as the percentage of participants with a confirmed investigator-assessed response of either complete response (CR) or partial response (PR) from the date of re-initiation of treatment with durvalumab monotherapy. Tumor assessments were performed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions (TLs) since baseline and reduction in short axis diameter to \<10 millimeters (mm) for any pathological lymph nodes selected as TLs. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameter.
Time frame: Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
Cohort 2: Duration of Response (DOR)
The DOR was defined as the time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. Tumor assessments were performed according to RECIST v1.1.
Time frame: Tumor assessments as determined by the Investigator (at least every 12 weeks) until withdrawal of consent, progression or death; approximately 30 months
Number of Participants Who Were Alive
Number of participants who were alive are reported in this outcome measure. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
Time frame: Up to approximately 37 months
This Phase IV, open-label study was conducted at 112 investigational sites across 31 countries in participants who were receiving durvalumab monotherapy and/or those who previously received durvalumab as a monotherapy or in combination with any other approved or investigational anticancer agent in previously enrolled parent study between 05 Sep 2019 and 31 Oct 2022.
| Milestone | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| Started | 100 | 25 | 38 |
| Received treatment in this study/within 90 days prior enrolment in this study(safety analysis set) | 100 | 7 | 2 |
| Completed | 0 | 0 | 0 |
| Not completed | 100 | 25 | 38 |
| Withdrew: Other | 83 | 22 | 25 |
| Withdrew: Development of study specific withdrawal criteria | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 5 | 0 | 1 |
| Withdrew: Death | 10 | 2 | 12 |
| Withdrew: Adverse event | 1 | 0 | 0 |
An AE was the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A SAE was an AE occurring during any study phase that fulfilled one or more of the following: resulted in death; was immediately life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital abnormality or birth defect; was an important medical event that jeopardized the participant or required medical treatment to prevent one of the outcomes listed above.
| Participants | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| Any AEs | 85 | 1 | 0 |
| Any SAEs | 23 | 0 | 0 |
The ORR was defined as the percentage of participants with a confirmed investigator-assessed response of either complete response (CR) or partial response (PR) from the date of re-initiation of treatment with durvalumab monotherapy. Tumor assessments were performed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions (TLs) since baseline and reduction in short axis diameter to \<10 millimeters (mm) for any pathological lymph nodes selected as TLs. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameter.
| percentage of participants | Cohort 2: Durvalumab Restart |
|---|---|
| Cohort 2: Overall Response Rate (ORR) | 0 (0 to 84) |
The DOR was defined as the time from first documented CR or PR to time of first documented disease progression or death in the absence of disease progression. Tumor assessments were performed according to RECIST v1.1.
| months | Cohort 2: Durvalumab Restart |
|---|---|
| Cohort 2: Duration of Response (DOR) | NA (NA to NA) |
Number of participants who were alive are reported in this outcome measure. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive.
| Participants | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| Number of Participants Who Were Alive | 90 | 23 | 26 |
Collected over From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: Durvalumab Continuation | 10/100 (10%) | 23/100 (23%) | 72/100 (72%) |
| Cohort 2: Durvalumab Restart | 2/25 (8%) | 0/7 (0%) | 1/7 (14.3%) |
| Cohort 3: No Restart of Durvalumab | 12/38 (31.6%) | 0/2 (0%) | 0/2 (0%) |
| Event | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| PneumoniaInfections and infestations | 3/100 | 0/7 | 0/2 |
| Brain oedemaNervous system disorders | 2/100 | 0/7 | 0/2 |
| Acute myocardial infarctionCardiac disorders | 1/100 | 0/7 | 0/2 |
| Lipase increasedInvestigations | 1/100 | 0/7 | 0/2 |
| Cardiac failureCardiac disorders | 1/100 | 0/7 | 0/2 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/100 | 0/7 | 0/2 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/100 | 0/7 | 0/2 |
| Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/100 | 0/7 | 0/2 |
| Oesophageal carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/100 | 0/7 | 0/2 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/100 | 0/7 | 0/2 |
| Event | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| HypothyroidismEndocrine disorders | 17/100 | 0/7 | 0/2 |
| COVID-19Infections and infestations | 17/100 | 0/7 | 0/2 |
| Intracranial aneurysmNervous system disorders | 0/100 | 1/7 | 0/2 |
| Escherichia infectionInfections and infestations | 0/100 | 1/7 | 0/2 |
| Aspartate aminotransferase increasedInvestigations | 11/100 | 0/7 | 0/2 |
| FatigueGeneral disorders | 11/100 | 0/7 | 0/2 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 9/100 | 0/7 | 0/2 |
| Back painMusculoskeletal and connective tissue disorders | 9/100 | 0/7 | 0/2 |
| AstheniaGeneral disorders | 9/100 | 0/7 | 0/2 |
| Blood creatinine increasedInvestigations | 8/100 | 0/7 | 0/2 |
The Full analysis set included all participants enrolled in the study, regardless of the treatment received.
| Age, Continuous(years) | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab | Total |
|---|---|---|---|---|
| Mean | 65.5 ± 10.31 | 66.4 ± 9.30 | 66.1 ± 9.95 | 65.7 ± 10.03 |
| Sex: Female, Male(Participants) | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab | Total |
|---|---|---|---|---|
| Female | 18 | 7 | 16 | 41 |
| Male | 82 | 18 | 22 | 122 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab | Total |
|---|---|---|---|---|
| White | 75 | 16 | 21 | 112 |
| Black or African American | 0 | 1 | 1 | 2 |
| Asian | 25 | 8 | 16 | 49 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab | Total |
|---|---|---|---|---|
| Hispanic or Latino | 9 | 0 | 0 | 9 |
| Not Hispanic or Latino | 91 | 23 | 37 | 151 |
| Missing | 0 | 2 | 1 | 3 |
Showing the first 100 of 116 sites across 31 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.
Supporting information: Study protocol, Sap
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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