Trial · NCT01335009

Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

NCT01335009, Phase 2, Completed, Eisai Inc.; results first posted 2021-09-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma. Trials, record NCT01335009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335009

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
NCT number: NCT01335009
Status: Completed
Phases: Phase 2
Enrollment: 76 participants, actual
Lead sponsor: Eisai Inc.
Conditions: Metastatic Melanoma
Interventions: MORAb-004 (monoclonal antibody)
First posted: 2011-04-13
Last updated: 2021-09-01
Other registries' IDs: eudract:2011-001282-40
Results first posted: 2021-09-01

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Progression-free Survival (PFS) at Week 24	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.
Secondary	Percentage of Participants With PFS at Weeks 16 and 52	Week 16 and Week 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.
Secondary	Overall Survival (OS)	Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months	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).
Secondary	Percentage of Participants With Overall Response	Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months	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).
Secondary	Optimal Biologic Dosing (OBD) of Morab-004	Day 1 Cycle 1 (Cycle length = 28 days)	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Progression-free Survival (PFS) at Week 24	Week 24	Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With PFS at Weeks 16 and 52	Week 16 and Week 52	Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized.	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months	Primary efficacy population included all participants in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.	weeks	MEDIAN
SECONDARY	Percentage of Participants With Overall Response	Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months	ORR population included a subset of participants from the primary efficacy population who had at least 1 on-study radiologic evaluation performed (in addition to their baseline evaluation), analyzed by the dose level received.	percentage of participants	NUMBER
SECONDARY	Optimal Biologic Dosing (OBD) of Morab-004	Day 1 Cycle 1 (Cycle length = 28 days)	All participants in the safety population who receive at least one dose of MORAb-004 and who had at least one on-treatment PK/PD assessment performed that is sufficient to evaluate the endpoint of interest. Here overall number of participants analyzed are participants who were available for this outcome measure.	milligram(s)	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Progression-free Survival (PFS) at Week 24	MORAb-004 2 mg/kg		13.5	95% Confidence Interval 5.0 to 26.4	percentage of participants
Percentage of Participants With Progression-free Survival (PFS) at Week 24	MORAb-004 4 mg/kg		8.9	95% Confidence Interval 2.3 to 21.3	percentage of participants
Percentage of Participants With PFS at Weeks 16 and 52	MORAb-004 2 mg/kg	Week 16	32.5	95% Confidence Interval 18.3 to 47.6	percentage of participants
Percentage of Participants With PFS at Weeks 16 and 52	MORAb-004 4 mg/kg	Week 16	20.8	95% Confidence Interval 9.2 to 35.7	percentage of participants
Percentage of Participants With PFS at Weeks 16 and 52	MORAb-004 2 mg/kg	Week 52	NA	95% Confidence Interval NA to NA	percentage of participants
Percentage of Participants With PFS at Weeks 16 and 52	MORAb-004 4 mg/kg	Week 52	8.9	95% Confidence Interval 2.3 to 21.3	percentage of participants
Overall Survival (OS)	MORAb-004 2 mg/kg		40.9	95% Confidence Interval 29.0 to 53.3	weeks
Overall Survival (OS)	MORAb-004 4 mg/kg		29.3	95% Confidence Interval 22.9 to 35.4	weeks
Percentage of Participants With Overall Response	MORAb-004 2 mg/kg		NA	95% Confidence Interval NA to NA	percentage of participants
Percentage of Participants With Overall Response	MORAb-004 4 mg/kg		3.1	95% Confidence Interval 0.0 to 9.2	percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MORAb-004 2 mg/kg	40
Overall Study	STARTED	MORAb-004 4 mg/kg	36
Overall Study	COMPLETED	MORAb-004 2 mg/kg	9
Overall Study	COMPLETED	MORAb-004 4 mg/kg	3
Overall Study	NOT COMPLETED	MORAb-004 2 mg/kg	31
Overall Study	NOT COMPLETED	MORAb-004 4 mg/kg	33

Source ClinicalTrials.gov

Adverse events498

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fatigue	General disorders	MORAb-004 2 mg/kg	18	40	28
other	Fatigue	General disorders	MORAb-004 4 mg/kg	18	36	28
other	Chills	General disorders	MORAb-004 2 mg/kg	13	40	13
other	Chills	General disorders	MORAb-004 4 mg/kg	18	36	20
other	Pyrexia	General disorders	MORAb-004 2 mg/kg	9	40	11
other	Pyrexia	General disorders	MORAb-004 4 mg/kg	12	36	17
other	Infusion related reaction	General disorders	MORAb-004 2 mg/kg	4	40	4
other	Infusion related reaction	General disorders	MORAb-004 4 mg/kg	1	36	3
other	Oedema peripheral	General disorders	MORAb-004 2 mg/kg	4	40	4
other	Oedema peripheral	General disorders	MORAb-004 4 mg/kg	3	36	6

1 to 10 of 498Source ClinicalTrials.gov

See all 498 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MORAb-004 2 mg/kg	28	40
Total, all-cause mortality	MORAb-004 4 mg/kg	32	36
Total, other adverse events	MORAb-004 2 mg/kg	40	40
Total, other adverse events	MORAb-004 4 mg/kg	36	36
Total, serious adverse events	MORAb-004 2 mg/kg	17	40
Total, serious adverse events	MORAb-004 4 mg/kg	16	36

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
MORAb-004 2 mg/kg vs MORAb-004 4 mg/kg: deaths from any cause	Trial comparisons
MORAb-004 2 mg/kg vs MORAb-004 4 mg/kg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01335009

GET https://conductscience.org/api/trials/v1/NCT01335009/events?page=2

API reference For AI assistants