Trial · NCT03126630
Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma
NCT03126630, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma. Trials, record NCT03126630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126630
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma
- NCT number
- NCT03126630
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Pleural Malignant Mesothelioma
- Interventions
- Anetumab Ravtansine, Laboratory Biomarker Analysis, Pembrolizumab, Pharmacological Study
- First posted
- 2017-04-24
- Last updated
- 2026-10-15
- Results first posted
- 2024-10-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2 Confirmed Tumor Response Rate (Phase II) | Up to 2 years | Will be assessed using Response Evaluation Criteria in Solid Tumors version 1.1 criteria. The proportion of successes will be estimated in each group by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated in each arm. Comparison of confirmed response rates between the two treatment groups will be performed using a one-sided z-test with pooled variance at significance level 0.10. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Primary | Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab | Up to 2 years | All patients that have received any amount of the combination anetumab ravtansine and pembrolizumab will be evaluable for toxicity. Please note this is different from the definition of evaluable for dose-limiting toxicity (DLT) where patients who cannot complete the planned dose due to reasons other than toxicity will be replaced. |
| Secondary | Phase 2 Duration of Response | Up to 2 years | Will be defined as evaluable patients who achieved noted to be a partial response or complete response based Response Evaluation Criteria in Solid Tumors version 1.1 criteria. Will be estimated using the method of Kaplan-Meier. The comparison of duration of response between two treatment arms will be based on the log-rank test. This calculation will start with the date of start of treatment. |
| Secondary | Phase 2 Overall Survival | From the start of treatment to death due to any cause, assessed up to 2 years | Will be estimated using the method of Kaplan-Meier. The comparison of overall survival in event of death between two treatment arms will be based on the log-rank test. |
| Secondary | Phase 2 Progression Free Survival | From the start of treatment to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years | Will be estimated using the method of Kaplan-Meier. The comparison of progression-free survival between two treatment arms will be based on the log-rank test. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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 | Pharmacokinetics of Anetumab Ravtansine | 0, 1, 3, 7, 168 hours post-dose | Area under the concentration-time curve from time 0 to 168 h (AUC 0-168h) |
| Secondary | Change in Megakaryocyte Potentiating Factor Levels Assessed in Tumor | Baseline up to 2 years | Relative changes in biomarker levels will be compared by best overall response groups using the non-parametric Wilcoxon rank-sum test. Also, the associations between changes in megakaryocyte potentiating factor levels and ordered response categories (i.e. complete response-partial response-stable disease-progressive disease) will be assessed with the Jonckheere-Terpstra test for trend. |
| Secondary | Mononuclear Phagocyte System -FcgammaRs and Chemokine Mediators of Mononuclear Phagocyte System | Up to 2 years | The mean equivalent soluble fluorophore and antibody bound to cell (ABC) will be determined for each specimen. Linear regression will be used to explore the linear relationship between the continuous values of these mononuclear phagocyte system-FcgammaRs probes and anetumab ravtansine levels. The concentrations of CCL2 and CCL5 will be determined for each specimen. Linear regression will be used to explore the linear relationship between the continuous values of these chemokines and anetumab ravtansine levels.The linear association between CD64 expression (ABC) and volume of distribution (Vd) was evaluated using correlation analysis in participants. Results are reported as correlation coefficient (R). |
| Secondary | Number of Grade 3+ Adverse Events | Up to 2 years | To explore the symptomatic adverse events (AE) for tolerability of each treatment group using Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE). |
| Other | CL Pharmacokinetics of Anetumab Ravtansine | Up to 2 years | Will be largely descriptive. Changes over time will be plotted and assessed for each patient. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 2 Confirmed Tumor Response Rate (Phase II) | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Phase I - Recommended Phase 2 Dose of Ametumab Ravtansine With Combination of Pembrolizumab | Up to 2 years | mg/kg IV | NUMBER | |
| SECONDARY | Phase 2 Duration of Response | Up to 2 years | Data were not collected and the outcome cannot be reported. | ||
| SECONDARY | Phase 2 Overall Survival | From the start of treatment to death due to any cause, assessed up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Phase 2 Progression Free Survival | From the start of treatment to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics of Anetumab Ravtansine | Days 1 and 3 of courses 1 and 8 | |||
| SECONDARY | Change in Megakaryocyte Potentiating Factor Levels Assessed in Tumor | Baseline up to 2 years | |||
| SECONDARY | Mononuclear Phagocyte System -FcgammaRs and Chemokine Mediators of Mononuclear Phagocyte System | Up to 2 years | |||
| SECONDARY | Incidence of Adverse Events | Up to 2 years |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group I (Pembrolizumab) | NE | 2 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group II (Anetumab Ravtansine, Pembrolizumab) | NE | 4 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group I (Pembrolizumab) | PD (Preliminary) | 6 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group II (Anetumab Ravtansine, Pembrolizumab) | PD (Preliminary) | 2 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group I (Pembrolizumab) | PD (Confirmed) | 3 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group II (Anetumab Ravtansine, Pembrolizumab) | PD (Confirmed) | 1 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group I (Pembrolizumab) | SD | 5 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group II (Anetumab Ravtansine, Pembrolizumab) | SD | 9 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group I (Pembrolizumab) | PR (Confirmed) | 1 | Participants | |
| Phase 2 Confirmed Tumor Response Rate (Phase II) | Group II (Anetumab Ravtansine, Pembrolizumab) | PR (Confirmed) | 2 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 2 Group I (Pembrolizumab) | 18 | |
| Overall Study | STARTED | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 18 | |
| Overall Study | STARTED | Phase 1 Cohort Dose Level 1 | 13 | |
| Overall Study | COMPLETED | Phase 2 Group I (Pembrolizumab) | 18 | |
| Overall Study | COMPLETED | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 17 | |
| Overall Study | COMPLETED | Phase 1 Cohort Dose Level 1 | 13 | |
| Overall Study | NOT COMPLETED | Phase 2 Group I (Pembrolizumab) | 0 | |
| Overall Study | NOT COMPLETED | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 1 | |
| Overall Study | NOT COMPLETED | Phase 1 Cohort Dose Level 1 | 0 |
Source ClinicalTrials.gov
Adverse events504
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 | Anemia | Blood and lymphatic system disorders | Phase 2 Group I (Pembrolizumab) | 7 | 17 | 42 |
| other | Anemia | Blood and lymphatic system disorders | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 7 | 18 | 32 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Cohort DLT 1 | 7 | 13 | 54 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Phase 2 Group I (Pembrolizumab) | 2 | 17 | 9 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 4 | 18 | 24 |
| other | Blood and lymph sys disorders - Oth Spec | Blood and lymphatic system disorders | Phase 1 Cohort DLT 1 | 1 | 13 | 12 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Phase 2 Group I (Pembrolizumab) | 0 | 17 | 0 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 1 | 18 | 3 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Phase 1 Cohort DLT 1 | 0 | 13 | 0 |
| other | Heart failure | Cardiac disorders | Phase 2 Group I (Pembrolizumab) | 1 | 17 | 1 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2 Group I (Pembrolizumab) | 1 | 17 |
| Total, all-cause mortality | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 2 | 18 |
| Total, all-cause mortality | Phase 1 Cohort DLT 1 | 1 | 13 |
| Total, other adverse events | Phase 2 Group I (Pembrolizumab) | 17 | 17 |
| Total, other adverse events | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 18 | 18 |
| Total, other adverse events | Phase 1 Cohort DLT 1 | 13 | 13 |
| Total, serious adverse events | Phase 2 Group I (Pembrolizumab) | 1 | 17 |
| Total, serious adverse events | Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) | 2 | 18 |
| Total, serious adverse events | Phase 1 Cohort DLT 1 | 1 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186686 | NCI Experimental Therapeutics-Clinical Trials Network with Phase 1 Emphasis | ADJEI, ALEX A. | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 2014 to 2019 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group I (Pembrolizumab) vs Group II (Anetumab Ravtansine, Pembrolizumab): Phase 2 Progression Free Survival | Trial comparisons |
| Group I (Pembrolizumab) vs Group II (Anetumab Ravtansine, Pembrolizumab): Phase 2 Overall Survival | 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/NCT03126630
GET https://conductscience.org/api/trials/v1/NCT03126630/events?page=2