Trial · NCT01843374

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

NCT01843374, Phase 2, Active not recruiting, MedImmune LLC; results first posted 2017-08-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma. Trials, record NCT01843374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01843374

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Trial

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

Title: Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma
NCT number: NCT01843374
Status: Active not recruiting
Phases: Phase 2
Enrollment: 571 participants, actual
Lead sponsor: MedImmune LLC
Conditions: Unresectable Pleural or Peritoneal Malignant Mesothelioma
Interventions: Tremelimumab, Placebo
First posted: 2013-04-30
Last updated: 2026-07-27
Other registries' IDs: eudract:2012-003524-21
Results first posted: 2017-08-17
Limitations and caveats: Baseline characteristics and efficacy outcomes are from the primary analysis reported in the main CSR based on a DCO of 24th January 2016. Participant flow and AE results are from the CSR Addendum based on a DBL of 23 January 2017.

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	3 years.	Overall survival (OS) by treatment arm
Secondary	OS Rate at 18 Months by Treatment Arm	18 months	The percentage of patients still alive at 18 months
Secondary	Progression-free Survival by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary	Overall Response Rate by Treatment Arm	Time from randomization to best response to treatment, assessed up to 3 years.	Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Secondary	Duration of Response by Treatment Arm	Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.	Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.
Secondary	Disease Control Rate by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration
Secondary	Durable Disease Control Rate by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration
Secondary	Number of Participants Reporting Any Adverse Event	Day 1- 90 days post dose	Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Secondary	Number of Participants Reporting Any Serious Adverse Events	Day 1 to 90 days post dose
Secondary	Number of Participants With Positive Anti-drug Antibodies	Week 5	The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	3 years.	ITT population	Number of Participants	NUMBER
SECONDARY	OS Rate at 18 Months by Treatment Arm	18 months	ITT population	Percentage of Participants	NUMBER
SECONDARY	Progression-free Survival by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	ITT population	Months	MEDIAN
SECONDARY	Overall Response Rate by Treatment Arm	Time from randomization to best response to treatment, assessed up to 3 years.	ITT population	Percentage	NUMBER
SECONDARY	Duration of Response by Treatment Arm	Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.	ITT	Months	MEDIAN
SECONDARY	Disease Control Rate by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	ITT population	Percentage	NUMBER
SECONDARY	Durable Disease Control Rate by Treatment Arm	Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.	ITT population	Percentage	NUMBER
SECONDARY	Number of Participants Reporting Any Adverse Event	Day 1- 90 days post dose	Safety population	Participants	NUMBER
SECONDARY	Number of Participants Reporting Any Serious Adverse Events	Day 1 to 90 days post dose	Safety population	Participants	NUMBER
SECONDARY	Number of Participants With Positive Anti-drug Antibodies	Week 5	Safety population	Participants	NUMBER

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Overall Survival (OS)	PLACEBO	Number of patients with Events (Death)	154		Number of Participants
Overall Survival (OS)	TREMELIMUMAB	Number of patients with Events (Death)	307		Number of Participants
Overall Survival (OS)	PLACEBO	Number patients censored <= 2 weeks before DCO	25		Number of Participants
Overall Survival (OS)	TREMELIMUMAB	Number patients censored <= 2 weeks before DCO	58		Number of Participants
Overall Survival (OS)	PLACEBO	Number of patients censored > 2 weeks before DCO	10		Number of Participants
Overall Survival (OS)	TREMELIMUMAB	Number of patients censored > 2 weeks before DCO	17		Number of Participants
OS Rate at 18 Months by Treatment Arm	TREMELIMUMAB		17.4	95% Confidence Interval 13.4 to 21.8	Percentage of Participants
OS Rate at 18 Months by Treatment Arm	PLACEBO		18.2	95% Confidence Interval 12.7 to 24.5	Percentage of Participants
Progression-free Survival by Treatment Arm	TREMELIMUMAB		2.69	95% Confidence Interval 2.66 to 2.76	Months
Progression-free Survival by Treatment Arm	PLACEBO		2.76	95% Confidence Interval 2.76 to 2.79	Months

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	PLACEBO	189
Overall Study	STARTED	TREMELIMUMAB	382
Overall Study	RANDOMIZED	PLACEBO	189
Overall Study	RANDOMIZED	TREMELIMUMAB	382
Overall Study	COMPLETED	PLACEBO	0
Overall Study	COMPLETED	TREMELIMUMAB	3
Overall Study	NOT COMPLETED	PLACEBO	189
Overall Study	NOT COMPLETED	TREMELIMUMAB	379

Source ClinicalTrials.gov

Adverse events434

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	Anaemia	Blood and lymphatic system disorders	PLACEBO	23	189	37
other	Anaemia	Blood and lymphatic system disorders	TREMELIMUMAB	54	380	76
other	Abdominal distension	Gastrointestinal disorders	PLACEBO	13	189	14
other	Abdominal distension	Gastrointestinal disorders	TREMELIMUMAB	16	380	18
other	Abdominal pain	Gastrointestinal disorders	PLACEBO	22	189	31
other	Abdominal pain	Gastrointestinal disorders	TREMELIMUMAB	44	380	54
other	Constipation	Gastrointestinal disorders	PLACEBO	53	189	62
other	Constipation	Gastrointestinal disorders	TREMELIMUMAB	65	380	82
other	Diarrhoea	Gastrointestinal disorders	PLACEBO	35	189	49
other	Diarrhoea	Gastrointestinal disorders	TREMELIMUMAB	168	380	368

1 to 10 of 434Source ClinicalTrials.gov

See all 434 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	PLACEBO	160	189
Total, all-cause mortality	TREMELIMUMAB	318	382
Total, other adverse events	PLACEBO	159	189
Total, other adverse events	TREMELIMUMAB	338	380
Total, serious adverse events	PLACEBO	85	189
Total, serious adverse events	TREMELIMUMAB	218	380

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28729154	DERIVED	PubMed
30883000	DERIVED	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 comparisons5

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

Comparison	Source
TREMELIMUMAB vs PLACEBO: Number of Participants With Positive Anti-drug Antibodies	Trial comparisons
TREMELIMUMAB vs PLACEBO: Number of Participants Reporting Any Adverse Event	Trial comparisons
TREMELIMUMAB vs PLACEBO: deaths from any cause	Trial comparisons
TREMELIMUMAB vs PLACEBO: Number of Participants Reporting Any Serious Adverse Events	Trial comparisons
TREMELIMUMAB vs PLACEBO: serious adverse events	Trial comparisons

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/NCT01843374

GET https://conductscience.org/api/trials/v1/NCT01843374/results?page=2

API reference For AI assistants