Phase 2
Completed N=89
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Source: ClinicalTrials.gov NCT00738582 ↗Enrolled (actual)
89
Serious AEs
36.6%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 — 26; 51 Participants
Summary
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6 |
26; 51 | — |
| SECONDARY Overall Response Rate (ORR) |
34.5 | — |
| SECONDARY Duration of Response (DR) |
9.2 | — |
| SECONDARY Time to Tumor Response (TTR) |
2.3 | — |
| SECONDARY Overall Survival (OS) |
14.8 | — |
| SECONDARY Overall Progression Free Survival |
6.3 | — |
Eligibility Criteria
Primary Inclusion Criteria:
- Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
- Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging [MRI]).
- KPS of greater than or equal to 70% at Screening.
- Life expectancy of at least 3 months
Primary Exclusion Criteria:
- Sarcomatous type of mesothelioma
- Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
- Confirmed presence of CNS tumor involvement.
- Evidence of other active malignancy requiring treatment.
Data sourced from ClinicalTrials.gov (NCT00738582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.