Trial · NCT02610140
Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
NCT02610140, Phase 2, Completed, Bayer; results first posted 2020-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM). Trials, record NCT02610140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02610140
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
- NCT number
- NCT02610140
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 248 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Mesothelioma
- Interventions
- Anetumab ravtansine (BAY94-9343), Vinorelbine
- First posted
- 2015-11-20
- Last updated
- 2020-11-04
- Other registries' IDs
- eudract:2012-003650-88
- Results first posted
- 2020-07-17
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS), [95% CI] | From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017) | Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period. |
| Secondary | Overall Survival (OS), [95% CI] | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment. | Overall survival (OS) was defined as time from randomization until death from any cause. |
| Secondary | Objective Response Rate (ORR) | up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause. | A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. |
| Secondary | Disease Control Rate (DCR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients. |
| Secondary | Duration of Response (DOR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. |
| Secondary | Durable Response Rate (DRR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more. |
| Secondary | Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma. |
| Secondary | Time to Worsening of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS. |
| Secondary | Time to Worsening of Pain | up to approx. 30 months (data cut-off: 31-May-2017) | Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score. |
| Secondary | Percentage of Participants With Confirmed Improvement of Pain | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS), [95% CI] | From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017) | The primary efficacy analysis (PFS) was performed in the ITT (Intent-to-treat) analysis set. | months | MEDIAN |
| SECONDARY | Overall Survival (OS), [95% CI] | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment. | The secondary efficacy analysis (OS) was performed in the ITT (Intent-to-treat) analysis set. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause. | The secondary efficacy analysis (ORR) was performed in the ITT (Intent-to-treat) analysis set. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | The secondary efficacy analysis (DCR) was performed in the ITT (Intent-to-treat) analysis set. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | The secondary efficacy analysis (DOR) was performed in the ITT (Intent-to-treat) analysis set. | months | MEDIAN |
| SECONDARY | Durable Response Rate (DRR) | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | The secondary efficacy analysis (DRR) was performed in the ITT (Intent-to-treat) analysis set. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set. | percentage of participants | NUMBER |
| SECONDARY | Time to Worsening of Symptoms Characteristic of Mesothelioma | up to approx. 30 months (data cut-off: 31-May-2017) | The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set. | days | MEDIAN |
| SECONDARY | Time to Worsening of Pain | up to approx. 30 months (data cut-off: 31-May-2017) | The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Confirmed Improvement of Pain | Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause. | The secondary efficacy analysis was performed in the ITT (Intent-to-treat) analysis set. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS), [95% CI] | Anetumab Ravtansine | 4.3 | 95% Confidence Interval 4.1 to 5.5 | months | |
| Progression-free Survival (PFS), [95% CI] | Vinorelbine | 4.5 | 95% Confidence Interval 4.1 to 5.8 | months | |
| Overall Survival (OS), [95% CI] | Anetumab Ravtansine | 9.5 | 95% Confidence Interval 8.3 to 12.3 | months | |
| Overall Survival (OS), [95% CI] | Vinorelbine | 11.6 | 95% Confidence Interval 8.6 to 13.1 | months | |
| Objective Response Rate (ORR) | Anetumab Ravtansine | 8.4 | 95% Confidence Interval 4.7 to 13.7 | percentage of participants | |
| Objective Response Rate (ORR) | Vinorelbine | 6.1 | 95% Confidence Interval 2.0 to 13.7 | percentage of participants | |
| Disease Control Rate (DCR) | Anetumab Ravtansine | 73.5 | 95% Confidence Interval 66.1 to 80.0 | percentage of participants | |
| Disease Control Rate (DCR) | Vinorelbine | 68.3 | 95% Confidence Interval 57.1 to 78.1 | percentage of participants | |
| Duration of Response (DOR) | Anetumab Ravtansine | 7.4 | 95% Confidence Interval 6.0 to NA | months | |
| Duration of Response (DOR) | Vinorelbine | 6.7 | 95% Confidence Interval 3.0 to 10.3 | months |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization and Treatment Period | STARTED | Anetumab Ravtansine (Experimental) | 166 | |
| Randomization and Treatment Period | STARTED | Vinorelbine (Active Comparator) | 82 | |
| Randomization and Treatment Period | Participants Received Treatment | Anetumab Ravtansine (Experimental) | 163 | |
| Randomization and Treatment Period | Participants Received Treatment | Vinorelbine (Active Comparator) | 72 | |
| Randomization and Treatment Period | COMPLETED | Anetumab Ravtansine (Experimental) | 0 | |
| Randomization and Treatment Period | COMPLETED | Vinorelbine (Active Comparator) | 0 | |
| Randomization and Treatment Period | NOT COMPLETED | Anetumab Ravtansine (Experimental) | 166 | |
| Randomization and Treatment Period | NOT COMPLETED | Vinorelbine (Active Comparator) | 82 | |
| Safety Follow-up | STARTED | Anetumab Ravtansine (Experimental) | 102 | |
| Safety Follow-up | STARTED | Vinorelbine (Active Comparator) | 45 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events812
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 | Anetumab Ravtansine (BAY94-9343) | 15 | 163 | 25 |
| other | Anaemia | Blood and lymphatic system disorders | Vinorelbine | 20 | 72 | 42 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Anetumab Ravtansine (BAY94-9343) | 0 | 163 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Vinorelbine | 3 | 72 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Anetumab Ravtansine (BAY94-9343) | 2 | 163 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Vinorelbine | 5 | 72 | 12 |
| other | Neutropenia | Blood and lymphatic system disorders | Anetumab Ravtansine (BAY94-9343) | 3 | 163 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Vinorelbine | 35 | 72 | 80 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anetumab Ravtansine (BAY94-9343) | 8 | 163 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vinorelbine | 0 | 72 | 0 |
1 to 10 of 812Source ClinicalTrials.gov
See all 812 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anetumab Ravtansine (BAY94-9343) | 126 | 163 |
| Total, all-cause mortality | Vinorelbine | 55 | 72 |
| Total, other adverse events | Anetumab Ravtansine (BAY94-9343) | 161 | 163 |
| Total, other adverse events | Vinorelbine | 68 | 72 |
| Total, serious adverse events | Anetumab Ravtansine (BAY94-9343) | 56 | 163 |
| Total, serious adverse events | Vinorelbine | 25 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35358455 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anetumab Ravtansine (BAY94-9343) vs Vinorelbine: deaths from any cause | Trial comparisons |
| Anetumab Ravtansine (BAY94-9343) vs Vinorelbine: 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.
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/NCT02610140
GET https://conductscience.org/api/trials/v1/NCT02610140/results?page=2