A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma

Phase 1

• Conditions: Metastaic Melanoma; MedDRA version: 14.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001282-40-DE
• Lead Sponsor: Morphotek Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-16
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

[1] At least 18 years of age
[2] Surgically sterile or who consent to use a medically acceptable method of contraception throughout the study period
[3] Histologically confirmed diagnosis of metastatic cutaneous (nonocular, nonmucosal) melanoma
[4] At least one prior systemic treatment for metastatic melanoma with disease progression following treatment
[5] Measurable disease, as defined by RECIST v.1.1, assessed within 4 weeks prior to study entry
[6] Prior anticancer therapy (chemotherapy, immunotherapy, or radiation therapy) must have been completed at least 3 weeks (21 days) prior to starting MORAb-004
therapy, and all treatment-associated toxicity must be resolved to Grade 1 or less before the first infusion of study drug (MORAb-004)
[7] Life expectancy of at least 3 months as estimated by the investigator
[8] Any other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
[9] ECOG Performance Status of 0 or 1 at screening
[10] Disease sites amenable to protocol-specified tissue biopsy (Note: All subjects will have protocol-specified biopsy at screening. The second, on-treatment biopsy will be required in the first 30 randomized subjects and is optional for all subsequently randomized subjects.)[11] Willingness and ability to provide written informed consent
[12] Laboratory test results within 14 days prior to Study Day 1: Absolute neutrophil count at least 1.5×10^9/L; Platelet count at least 100 × 10^9/L; Hemoglobin at least 8 g/dL; Creatinine no greater than 1.5 × ULN (NCI CTCAE Grade 1); Bilirubin less than 1.5 × ULN (NCI CTCAE Grade 1); Aspartate aminotransferase and alkaline phosphatase less than 2.5 × ULN (NCI CTCAE Grade 1); Activated partial thromboplastin time (aPTT) and prothrombin time (PT) less than 1.5 × ULN (NCI CTCAE Grade 1)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

[1] No prior systemic treatment for metastatic melanoma
[2] Evidence of active malignancy other than metastatic melanoma requiring treatment within the last 5 years (other than basal cell or squamous cell skin cancer)
[3] Clinically significant heart disease
[4] ECG demonstrating clinically significant arrhythmia
[5] Any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic use of systemic corticosteroids (use for at least 4 consecutive weeks)
[6] Active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is not exclusionary.)
[7] Breast-feeding, pregnant, or likely to become pregnant during the study
[8] Known allergic reaction to a prior monoclonal antibody therapy
[9] Previous treatment with MORAb-004 (anti-TEM-1)
[10] Any evidence of brain metastasis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: [1] To evaluate the rate of Progression-Free-Survival (PFS) at 24 weeks of 2 dose levels of MORAb-004 in subjects with metastatic melanoma based on Response evaluation Criteria in Solid Tumors (RECIST) v 1.1;Secondary Objective: [1] To evaluate the Optimal Biological Dose (OBD) of MORAb-004 using a Pharmacokinetic (PK)/Pharmacodynamic (PD) model of drug activity<br>[2] To correlate the pattern of TEM-1 expression in tumor samples with clinical parameters, including PFS<br>[3] To assess the following additional clinical parameters: PFS over the course of the study, Overall survival (OS), Safety and tolerability of MORAb-004, and Tumor tissue-based and serum-based PD biomarkers;Primary end point(s): [1] PFS;Timepoint(s) of evaluation of this end point: 24 week PFS<br>Imaging by MRI/CT: screening, D22 (even # cycles), final visit