Trial · NCT03126630
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | Vd Pharmacokinetics of Anetumab Ravtansine | Up to 2 years | Will be largely descriptive. Changes over time will be plotted and assessed for each patient. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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