Trial · NCT02899195
Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
NCT02899195, Phase 2, Completed, PrECOG, LLC.; results first posted 2021-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma. Trials, record NCT02899195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02899195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II MEDI4736 in Combination With Chemotherapy for First-Line Treatment of Unresectable Mesothelioma
- NCT number
- NCT02899195
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- PrECOG, LLC.
- Conditions
- Mesothelioma, Pleural Mesothelioma
- Interventions
- Durvalumab
- First posted
- 2016-09-14
- Last updated
- 2023-07-05
- Results first posted
- 2021-04-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization until death, up to 32 months | Overall survival (OS) is defined as the time from randomization to death from any cause. Patients that have not had an event reported at analysis will be censored at their date of last follow-up. |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Up to 15 months from start of treatment | Number of participants with abnormal laboratory values and/or adverse events related to treatment. |
| Secondary | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause, up to 32 months | Progression-free survival (PFS) is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free. |
| Secondary | Time to Progression (TTP) on Durvalumab | From time concurrent treatment started until progression, up to 32 months | TTP measured from the time concurrent treatment with chemotherapy/durvalumab begins until radiologic or clinical progression is noted. |
| Secondary | Objective Response Rate (ORR) | From randomization until end of treatment, up to 15 months | ORR assessed in accordance with RECIST 1.1 (modified for malignant mesothelioma). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization until death, up to 32 months | All eligible and treated patients | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Up to 15 months from start of treatment | treated population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause, up to 32 months | Eligible and treated population | month | MEDIAN |
| SECONDARY | Time to Progression (TTP) on Durvalumab | From time concurrent treatment started until progression, up to 32 months | Eligible and treated patients | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From randomization until end of treatment, up to 15 months | Eligible and treated patient population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Concurrent Durvalumab Then Maintenance Durvalumab | 20.4 | 95% Confidence Interval 13.0 to 28.5 | months | |
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 | Concurrent Durvalumab Then Maintenance Durvalumab | 36 | Participants | ||
| Progression-Free Survival (PFS) | Concurrent Durvalumab Then Maintenance Durvalumab | 6.7 | 95% Confidence Interval 6.1 to 8.4 | month | |
| Time to Progression (TTP) on Durvalumab | Concurrent Durvalumab Then Maintenance Durvalumab | 6.8 | 95% Confidence Interval 6.2 to 8.4 | months | |
| Objective Response Rate (ORR) | Concurrent Durvalumab Then Maintenance Durvalumab | 31 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Concurrent Durvalumab | STARTED | Concurrent Durvalumab Then Maintenance Durvalumab | 55 | |
| Concurrent Durvalumab | COMPLETED | Concurrent Durvalumab Then Maintenance Durvalumab | 44 | |
| Concurrent Durvalumab | NOT COMPLETED | Concurrent Durvalumab Then Maintenance Durvalumab | 11 | |
| Maintenance Durvalumab | STARTED | Concurrent Durvalumab Then Maintenance Durvalumab | 44 | |
| Maintenance Durvalumab | COMPLETED | Concurrent Durvalumab Then Maintenance Durvalumab | 10 | |
| Maintenance Durvalumab | NOT COMPLETED | Concurrent Durvalumab Then Maintenance Durvalumab | 34 |
Source ClinicalTrials.gov
Adverse events106
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 | Concurrent Durvalumab Then Maintenance Durvalumab | 20 | 55 | |
| other | Hyperthyroidism | Endocrine disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 3 | 55 | |
| other | Hypothyroidism | Endocrine disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 8 | 55 | |
| other | Dry eye | Eye disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 7 | 55 | |
| other | Lacrimation increased | Eye disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 4 | 55 | |
| other | Abdominal distension | Gastrointestinal disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 3 | 55 | |
| other | Abdominal pain | Gastrointestinal disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 4 | 55 | |
| other | Constipation | Gastrointestinal disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 27 | 55 | |
| other | Diarrhoea | Gastrointestinal disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 13 | 55 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Concurrent Durvalumab Then Maintenance Durvalumab | 5 | 55 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Concurrent Durvalumab Then Maintenance Durvalumab | 33 | 55 |
| Total, other adverse events | Concurrent Durvalumab Then Maintenance Durvalumab | 55 | 55 |
| Total, serious adverse events | Concurrent Durvalumab Then Maintenance Durvalumab | 36 | 55 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT02899195
GET https://conductscience.org/api/trials/v1/NCT02899195/events?page=2