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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01335009




Registration number
NCT01335009
Ethics application status
Date submitted
14/03/2011
Date registered
13/04/2011
Date last updated
1/09/2021

Titles & IDs
Public title
Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Scientific title
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
Secondary ID [1] 0 0
2011-001282-40
Secondary ID [2] 0 0
MORAb-004-201MEL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - MORAb-004 (monoclonal antibody)

Experimental: MORAb-004, 2 mg/kg - Biologic (monoclonal antibody)

Experimental: MORAb-004, 4 mg/kg - Biologic (monoclonal antibody)


Other interventions: MORAb-004 (monoclonal antibody)
Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs or clinical or symptomatic progression as suggested by an investigator.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Progression-free Survival (PFS) at Week 24 - PFS was defined as the time (in weeks) from the date of randomization to the date of the first sign of disease progression (PD) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or date of death, regardless of cause. PD greater than or equal to (>=) 20 percent (%) increase in the nadir of total tumor burden (TTB) (minimum 5 millimeter [mm]). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received a new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was started. PFS was analyzed using Kaplan Meier method.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants With PFS at Weeks 16 and 52 - PFS was defined as the time (in weeks) from the date of randomization to the date of the first observation of PD (RECIST version 1.1) or date of death, regardless of the cause. PD >=20% increase in the nadir of TTB (minimum 5 mm). Participants who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Participants who received new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was initiated. PFS was based on the Kaplan-Meier method.
Timepoint [1] 0 0
Week 16 and Week 52
Secondary outcome [2] 0 0
Overall Survival (OS) - OS was defined as the time (in weeks) from the date of randomization to the date of death, regardless of cause. In the absence of death confirmation, or for participants alive at the time of analysis, the survival time was censored at the date of the last study follow-up. OS was calculated using the Kaplan-Meier method. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013).
Timepoint [2] 0 0
Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months
Secondary outcome [3] 0 0
Percentage of Participants With Overall Response - ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) that occurred (defined by RECIST version 1.1) using CT/MRI. Per RECIST 1.1, CR= disappearance of all lesions; PR greater than or equal to (>=) 30percent (%) decrease from baseline in TTB. As per planned analysis, efficacy outcomes was planned to be analyzed until cut-off date (02 December 2013).
Timepoint [3] 0 0
Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months
Secondary outcome [4] 0 0
Optimal Biologic Dosing (OBD) of Morab-004 - OBD is defined as the dose level/exposure level at which three parameters are met: 1) adequate pharmacokinetic (PK) profile with a serum half-life (t1/2) of >=48 hours, 2) at least minimal demonstration of antitumor efficacy (50% or greater PFS rate at 16 weeks), and 3) change of 25% or greater from baseline value in any of the pharmacodynamic (PD) parameters assessed in the study in 30% of participants at that dose level.
Timepoint [4] 0 0
Day 1 Cycle 1 (Cycle length = 28 days)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Sydney Cancer Center - Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Newcastle Melanoma Unit, Calvery Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
The Crown Princess Mary Cancer Centre, Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Germany
State/province [16] 0 0
Tuebingen
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/show/NCT01335009
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications