Trial · NCT03095274

Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin

NCT03095274, Phase 2, Completed, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2025-01-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin. Trials, record NCT03095274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03095274

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Trial

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

Title: Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin
NCT number: NCT03095274
Status: Completed
Phases: Phase 2
Enrollment: 126 participants, actual
Lead sponsor: Grupo Espanol de Tumores Neuroendocrinos
Conditions: Neuroendocrine Tumors, Neuroendocrine Neoplasm of Lung
Interventions: Durvalumab, Tremelimumab
First posted: 2017-03-29
Last updated: 2025-01-09
Other registries' IDs: eudract:2016-002858-20
Results first posted: 2025-01-09

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Clinical Benefit Rate (CBR)	9 months	by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, which is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) at month 9 after durvalumab plus tremelimumab was started. Assessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions; SD as no changes in target lesions (i.e. \<20% growth and \<30% decrease). CBR = CR + PR +SD. Some patients were not evaluable as they had no tumor assessments.
Primary	Overall Survival	Throughout the study period. Each patients has been followed approximately 24 months, up to 30 months.	Time between start of treatment and death. Here we report the median time to death from any cause, estimated by Kaplan Meier method. The times reported in here are the median time to event estimated by Kaplan Meier and that is why the number of months might be higher or lower than the overall and patient-specific follow-up.
Secondary	Overall Response Rate	9 months	by immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria. dAssessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions. ORR = CR + PR
Secondary	Duration of Response	Throughout the study period, approximately 24 months	by immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria. Assessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions. Response = CR + PR
Secondary	Progression Free Survival	Throughout the study period, approximately 24 months	by immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) criteria
Secondary	Safety - Toxicities as Defined by CTCAE, v4.0	9 months	Based on subjects who experienced toxicities as defined by CTCAE, v4.0 The attribution to drug, time-of-onset, duration of the event, its resolution, and any concomitant medications.
Secondary	Response Status	12 months	by irRECIST criteria, at 6, 9 and 12 months after start of study treatment. Assessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions. ORR = CR + PR
Secondary	Response Status	9 months	by irRECIST criteria, at 6, 9 and 12 months after start of study treatment. Assessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions. ORR = CR + PR
Secondary	Response Status	6 months	by irRECIST criteria, at 6, 9 and 12 months after start of study treatment. Assessed by Computed tomography scan (CT) or magnetic resonance imaging (MRI) CR is defined as disappearance of all target lesions; PR as \>=30% decrease in the sum of the longest diameter of target lesions. ORR = CR + PR

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Benefit Rate (CBR)	9 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Overall Survival	Throughout the study period. Each patients has been followed approximately 24 months, up to 30 months.		months	MEDIAN
SECONDARY	Overall Response Rate	9 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Response	Throughout the study period, approximately 24 months	No patient had a response to treatment (not CR, not PR)	months	MEDIAN
SECONDARY	Progression Free Survival	Throughout the study period, approximately 24 months		months	MEDIAN
SECONDARY	Safety - Toxicities as Defined by CTCAE, v4.0	9 months	In the following table, the most frequent toxicities are reported (toxicities with frequency ≥10%)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response Status	12 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response Status	9 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response Status	6 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group127

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

Outcome	Group	Category	Value	Units
Clinical Benefit Rate (CBR)	Cohort 1	CR	0	Participants
Clinical Benefit Rate (CBR)	Cohort 2	CR	0	Participants
Clinical Benefit Rate (CBR)	Cohort 3	CR	0	Participants
Clinical Benefit Rate (CBR)	Cohort 4	CR	1	Participants
Clinical Benefit Rate (CBR)	Cohort 1	PR	1	Participants
Clinical Benefit Rate (CBR)	Cohort 2	PR	0	Participants
Clinical Benefit Rate (CBR)	Cohort 3	PR	2	Participants
Clinical Benefit Rate (CBR)	Cohort 4	PR	1	Participants
Clinical Benefit Rate (CBR)	Cohort 1	SD	6	Participants
Clinical Benefit Rate (CBR)	Cohort 2	SD	11	Participants

1 to 10 of 127Source ClinicalTrials.gov

See all 127 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Durvalumab+Tremelimumab	123
Overall Study	COMPLETED	Durvalumab+Tremelimumab	123
Overall Study	NOT COMPLETED	Durvalumab+Tremelimumab	0

Source ClinicalTrials.gov

Adverse events508

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	Events
other	Fatigue Grade	General disorders	Cohort 1	13	27	13
other	Fatigue Grade	General disorders	Cohort 2	16	31	16
other	Fatigue Grade	General disorders	Cohort 3	20	32	20
other	Fatigue Grade	General disorders	Cohort 4	18	33	18
other	Diarrhea	Gastrointestinal disorders	Cohort 1	14	27	14
other	Diarrhea	Gastrointestinal disorders	Cohort 2	15	31	15
other	Diarrhea	Gastrointestinal disorders	Cohort 3	12	32	12
other	Diarrhea	Gastrointestinal disorders	Cohort 4	7	33	7
other	Pruritus Grade	Skin and subcutaneous tissue disorders	Cohort 1	5	27	5
other	Pruritus Grade	Skin and subcutaneous tissue disorders	Cohort 2	11	31	11

1 to 10 of 508Source ClinicalTrials.gov

See all 508 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1	9	27
Total, all-cause mortality	Cohort 2	17	31
Total, all-cause mortality	Cohort 3	21	32
Total, all-cause mortality	Cohort 4	30	33
Total, other adverse events	Cohort 1	27	27
Total, other adverse events	Cohort 2	31	31
Total, other adverse events	Cohort 3	32	32
Total, other adverse events	Cohort 4	33	33
Total, serious adverse events	Cohort 1	10	27
Total, serious adverse events	Cohort 2	15	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37221181	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.

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