Phase 2
Completed N=76
Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Source: ClinicalTrials.gov NCT01335009 ↗Enrolled (actual)
76
Serious AEs
43.4%
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Progression-free Survival (PFS) at Week 24 — 13.5; 8.9 percentage of participants
Summary
This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.
Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression.
Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy.
Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-free Survival (PFS) at Week 24 |
13.5; 8.9 | — |
| SECONDARY Percentage of Participants With PFS at Weeks 16 and 52 |
32.5; 20.8; NA; 8.9 | — |
| SECONDARY Overall Survival (OS) |
40.9; 29.3 | — |
| SECONDARY Percentage of Participants With Overall Response |
NA; 3.1 | — |
| SECONDARY Optimal Biologic Dosing (OBD) of Morab-004 |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period.
- Histologically confirmed diagnosis of metastatic melanoma
- At least 1 prior systemic treatment for metastatic melanoma with disease progression following treatment
- Measurable disease, as defined by RECIST v1.1, assessed within 4 weeks prior to study entry
- At least 3 week interval between first infusion of test article and most recent prior systemic anticancer therapy. All treatment-associated toxicity must be resolved to less than or equal to Grade 1 before the administration of MORAb-004
- Have a life expectancy of at least 3 months as estimated by the investigator
- Have other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Have sites of disease amenable to the protocol-specified biopsy (Note: All participants will have protocol-specified biopsy at Screening. The second, on-treatment biopsy will be mandatory in the first 30 randomized participants only. For all other participants, the second biopsy is optional.
- Laboratory tests results prior to Study Day 1 within limits as outlined in protocol
Exclusion Criteria
- Have received no prior systemic treatment for metastatic melanoma
- Evidence of other active malignancy requiring treatment within the last 5 years (other than basal cell or squamous cell carcinoma of the skin), or active brain metastasis
- Clinically significant heart disease (Congestive heart failure of New York Heart Association [NYHA] Class 3 or 4, angina not well controlled by medication, or myocardial infarction within 6 mos.), or ECGs demonstrating clinically significant arrhythmias
- Have any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic (at least 4 consecutive weeks) systemic corticosteroid use
- Have active viral hepatitis or symptomatic Human immunodeficiency virus (HIV) infection
- Be breast-feeding, pregnant, or likely to become pregnant during the study
- Known allergic reaction to a prior monoclonal antibody therapy
- Previous treatment with MORAb-004
- Brain metastasis
Data sourced from ClinicalTrials.gov (NCT01335009). 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.