Trial · NCT03084471

An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

NCT03084471, Phase 3, Completed, AstraZeneca; results first posted 2021-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies. Trials, record NCT03084471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03084471

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.
NCT number: NCT03084471
Status: Completed
Phases: Phase 3
Enrollment: 867 participants, actual
Lead sponsor: AstraZeneca
Conditions: Advanced Solid Malignancies
Interventions: MEDI4736 (Durvalumab), MEDI4736 (Durvalumab) + Tremelimumab
First posted: 2017-03-21
Last updated: 2022-12-22
Results first posted: 2021-06-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events of Special Interest (AESIs)	From screening to safety follow up visit (90 days after last dose), up to approximately 3 years.	Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.
Secondary	Overall Survival	From screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.	Overall survival was defined as the time from the first date of treatment until death due to any cause.
Secondary	Number of Participants With Adverse Events	From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.	Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of treatment-emergent AEs (including SAEs) will be assessed

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events of Special Interest (AESIs)	From screening to safety follow up visit (90 days after last dose), up to approximately 3 years.	Safety analysis set: all enrolled participants who received at least one dose of durvalumab.	participants	NUMBER
SECONDARY	Overall Survival	From screening to final data cutoff (maximum up to 4 years) following date of first patient treatment initiation.	Safety analysis set: all enrolled participants who received at least 1 dose of durvalumab.	months	MEDIAN
SECONDARY	Number of Participants With Adverse Events	From screening to safety follow up visit (90 days after last dose), maximum up to 4 years.	Safety analysis set: all enrolled participants who received at least one dose of durvalumab.	participants	NUMBER

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events of Special Interest (AESIs)	AESI	Any adverse event (AE)	265	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AEPI	Any adverse event (AE)	300	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	imAE	Any adverse event (AE)	97	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AESI	Any AE of common terminology criteria for AEs Grade 3 or 4	21	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AEPI	Any AE of common terminology criteria for AEs Grade 3 or 4	49	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	imAE	Any AE of common terminology criteria for AEs Grade 3 or 4	17	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AESI	Any serious adverse event (SAE) (including events with outcome = death)	19	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AEPI	Any serious adverse event (SAE) (including events with outcome = death)	13	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	imAE	Any serious adverse event (SAE) (including events with outcome = death)	11	participants
Number of Participants With Adverse Events of Special Interest (AESIs)	AESI	Any AE with outcome = death	1	participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Durvalumab	867
Overall Study	COMPLETED	Durvalumab	0
Overall Study	NOT COMPLETED	Durvalumab	867

Source ClinicalTrials.gov

Adverse events201

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Asthenia	General disorders	Durvalumab	228	867
other	Fatigue	General disorders	Durvalumab	83	867
other	Pyrexia	General disorders	Durvalumab	79	867
other	Oedema peripheral	General disorders	Durvalumab	75	867
other	Constipation	Gastrointestinal disorders	Durvalumab	171	867
other	Diarrhoea	Gastrointestinal disorders	Durvalumab	136	867
other	Nausea	Gastrointestinal disorders	Durvalumab	126	867
other	Vomiting	Gastrointestinal disorders	Durvalumab	76	867
other	Abdominal pain	Gastrointestinal disorders	Durvalumab	64	867
other	Anaemia	Blood and lymphatic system disorders	Durvalumab	172	867

1 to 10 of 201Source ClinicalTrials.gov

See all 201 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Durvalumab	600	867
Total, other adverse events	Durvalumab	669	867
Total, serious adverse events	Durvalumab	254	867

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35042068	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03084471

GET https://conductscience.org/api/trials/v1/NCT03084471/results?page=2

API reference For AI assistants