MCS110 in Patients With Pigmented Villonodular Synovitis... | NCT01643850 | Trialant
NCT01643850
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jan 5, 2021Actual
Enrollment
36Actual
Phase
Phase 2
Conditions
Pigmented Villonodular Synovitis
PVNS
Giant Cell Tumor of the Tendon Sheath
GCCTS
Tenosynovial Giant Cell Tumor Localized or Diffused Type
GCTS
Interventions
MCS110
Placebo
Countries
United States
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01643850
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CMCS110X2201
Secondary IDs
ID
Type
Description
Link
2011-002951-32
EudraCT Number
Brief Title
MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Official Title
A Phase II Randomized, Double -Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Feb 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 23, 2012Actual
Primary Completion Date
Dec 7, 2017Actual
Completion Date
Dec 21, 2018Actual
First Submitted Date
Mar 8, 2012
First Submission Date that Met QC Criteria
Jul 16, 2012
First Posted Date
Jul 18, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 20, 2019
Results First Submitted that Met QC Criteria
Feb 13, 2020
Results First Posted Date
Feb 27, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 13, 2018
Certification/Extension First Submitted that Passed QC Review
Aug 13, 2018
Certification/Extension First Posted Date
Aug 15, 2018Actual
Last Update Submitted Date
Dec 9, 2020
Last Update Posted Date
Jan 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, assessed the clinical response to MCS110 treatment in Pigmented Villonodular Synovitis (PVNS) patients, after a single or multiple intravenous doses of MCS110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.
Detailed Description
Not provided
Conditions Module
Conditions
Pigmented Villonodular Synovitis
PVNS
Giant Cell Tumor of the Tendon Sheath
GCCTS
Tenosynovial Giant Cell Tumor Localized or Diffused Type
GCTS
Keywords
Pigmented Villonodular Synovitis
PVNS
Giant cell tumor of the tendon sheath
GCCTS
Tenosynovial giant cell tumor (localized or diffused type)
GCTS
MCS110
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
36Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MCS110
Experimental
Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion.
Drug: MCS110
Placebo
Placebo Comparator
Part A: single-dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion) Part B: single dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion administered i.v. at Day 1, followed by 6 doses of placebo to match MCS110 (10 mg/kg)
Drug: Placebo
MCS110 3 mg/kg
Experimental
Part C: MCS110 3 mg/kg (i.v. infusion)
Drug: MCS110
MCS110 5 mg/kg
Experimental
Part C: MCS110 5 mg/kg (i.v. infusion)
Drug: MCS110
MCS110 10 mg/kg
Experimental
Part C: MCS110 10 mg/kg (i.v. infusion)
Drug: MCS110
MCS110 3 mg/kg & MCS110 10mg/kg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MCS110
Drug
Patients will receive up to 6 doses of MCS110 (3 or 5 or 10mg/kg) administered intravenously once every 4 weeks. Before each dosing, safety will be assessed.
MCS110
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Week 4
Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Week 4
Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 & 10 mg/kg or 5 & 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Males and Females aged ≥ 18 years (≥ 12 years in PART C) with PVNS or GCTTS with, at least, one measurable site of disease on MRI.
Patients expected to get surgery (PART A of study only).
Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
Patients with normal level of serum ionized calcium and phosphate.
Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.
Exclusion criteria:
Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
Use previously of intra-articular treatment within 4 weeks prior dosing.
Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
Patients engaged in a resistance exercise training program.
Patients with pacemakers or any metallic objects as exclusion for MRI
Patients with concomitant disease know to get influence on bone metabolism
Patients who have history of drug or alcohol abuse within 12 months prior study dosing.
Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Thirty-seven subjects diagnosed with PVNS or GCTTS were evaluated as part of this study. In all, 36 subjects were treated in three parts (Parts A, B and C) of the study, 30 of whom completed the study. At this final analysis, 6 treated subjects had discontinued from the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
FG001
Placebo (PART A)
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
Participants will receive a single dose of NaCl on day 1 through intravenous infusion.
Placebo
Intravenous infusion of placebo.
Up to 8 weeks post last dose
Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Up to 8 weeks post last dose
Number of Participants With Adverse Events
Overall incidence of Adverse Events
Approximately 2 years
Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time
Baseline, Day 1, Day 85, Day 169
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.
Baseline, Week 4, Week 24, Week 104
Number of Participants With Negative Anti-MCS110 Antibody
To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations
Baseline, throughout the study up to Day 505
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Week 4
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Week 24/28, Week 104
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
Up to Week 104
Time to Surgery
Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.
Up to Week 104
Average of Health-Related Quality of Life Questionnaire Score for mHAQ
The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values <0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.
up to 104 weeks
Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes
Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.
Baseline Up to Week 104
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).
Week 4, Week 24, up to 104 weeks
Denver
Colorado
80237
United States
Novartis Investigative Site
Washington D.C.
District of Columbia
20011
United States
Novartis Investigative Site
Miami
Florida
33136
United States
Novartis Investigative Site
Chicago
Illinois
60612
United States
Novartis Investigative Site
Minneapolis
Minnesota
55455
United States
Novartis Investigative Site
Philadelphia
Pennsylvania
19107
United States
Novartis Investigative Site
Basel
4056
Switzerland
A Plain Language Trial Summary is available on novartisclinicatrials.com
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
FG003
Placebo/10mg/kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
FG004
MCS110 3 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
FG005
MCS110 5 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
FG006
MCS110 10 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
FG007
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
FG008
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
FG0005 subjects
FG0012 subjects
FG0028 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0064 subjects
FG0074 subjects
FG0084 subjects
COMPLETED
FG0005 subjects
FG0012 subjects
FG0027 subjects
FG0033 subjects
FG0040 subjects
FG0053 subjects
FG0063 subjects
FG0074 subjects
FG0083 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0043 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Administrative Problems
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
BG001
Placebo (PART A)
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
BG002
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
BG003
Placebo/10mg/kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
BG004
MCS110 3 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
BG005
MCS110 5 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
BG006
MCS110 10 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
BG007
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
BG008
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0012
BG0028
BG0033
BG0043
BG0053
BG0064
BG0074
BG0084
BG00936
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00051.4± 8.96
BG00130.0± 4.24
BG00246.3± 10.14
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG0004
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Pharmacodynamic Analysis Set
Posted
Mean
Standard Deviation
mm3
Week 4
ID
Title
Description
OG000
Placebo (PART ABC4)
Single dose placebo from PART A and B
OG001
MCS110 3 mg/kg (PART ABC4)
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
OG002
MCS110 5 mg/kg (PART ABC4)
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
OG003
MCS110 10 mg/kg (PART ABC4)
Single dose MCS110 10 mg/kg
Units
Counts
Participants
OG0005
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4222.8± 6284.56
OG001-668.5± 18751.44
OG002-9998.4± 15628.40
OG003
Primary
Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size
To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Pharmacodynamic Analysis Set
Posted
Mean
Standard Deviation
Percentage
Week 4
ID
Title
Description
OG000
Placebo (PART ABC4)
Single dose placebo from PART A and B
OG001
MCS110 3 mg/kg (PART ABC4)
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
OG002
MCS110 5 mg/kg (PART ABC4)
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
OG003
MCS110 10 mg/kg (PART ABC4)
Primary
Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 & 10 mg/kg or 5 & 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]
Pharmacodynamic Analysis Set
Posted
Mean
Standard Deviation
mm3
Up to 8 weeks post last dose
ID
Title
Description
OG000
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Primary
Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size
To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Pharmacodynamic Analysis Set
Posted
Mean
Standard Deviation
Percentage
Up to 8 weeks post last dose
ID
Title
Description
OG000
MCS110 3 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (PART BC)
Primary
Number of Participants With Adverse Events
Overall incidence of Adverse Events
Safety Analysis Set
Posted
Count of Participants
Participants
Approximately 2 years
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10mg/kg on day 1 administered by i.v. infusion.
OG001
Placebo (PART A)
Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion)
OG002
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG003
Placebo (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg. Subset of MCS110 (Part B)
OG004
Secondary
Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)
Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).
Pharmacokinetic Analysis Set
Posted
Mean
Standard Deviation
h* ng/mL
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
OG001
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG002
Placebo/10 mg kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG003
MCS110 3 mg/kg (PART C)
Secondary
Pharmacokinetics of MCS110 Maximum Concentration (Cmax)
Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)
Pharmacokinetic Analysis Set
Posted
Mean
Standard Deviation
ng/mL
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
OG001
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG002
Placebo/10 mg kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG003
MCS110 3 mg/kg (PART C)
Secondary
Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)
Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)
Pharmacokinetic Analysis Set
Posted
Median
Full Range
hour (h)
Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
OG001
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG002
Placebo/10 mg kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG003
MCS110 3 mg/kg (PART C)
Secondary
Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time
Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time
Pharmacokinetic Analysis Set
Posted
Mean
Standard Deviation
pg/mL
Baseline, Day 1, Day 85, Day 169
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
OG001
Placebo/MCS110 10mg/kg (PART A)
Participants received single dose placebo to match MCS110 10 mg/k
OG002
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG003
Placebo/10 mg kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion)and then continued with monthly administration of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Secondary
Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).
Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.
Pharmacodynamic analysis
Posted
Median
Full Range
ng/mL
Baseline, Week 4, Week 24, Week 104
ID
Title
Description
OG000
MCS110 10 mg/kg (PART ABC4)
Participants received a single dose of MCS110 10 mg/kg
OG001
Placebo (PARTS A and B)
PART A: Participants received single dose placebo to match MCS110 10mg/kg (i.v. infusion). PART B: Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg.
Secondary
Number of Participants With Negative Anti-MCS110 Antibody
To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations
Safety analysis set
Posted
Number
Number of Participants
Baseline, throughout the study up to Day 505
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10mg/kg on day 1 administered by regular infusion.
OG001
Placebo (PART A)
Participants received single dose placebo to match MCS110 10 mg/kg
OG002
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG003
Placebo (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg (i.v. infusion) and then continued with monthly administration of MCS110 10 mg/kg
Secondary
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
Pharmacodynamic Analysis Set
Posted
Mean
Standard Deviation
Degree
Week 4
ID
Title
Description
OG000
Placebo (PART ABC4)
Single dose placebo from PART A and B
OG001
MCS110 3 mg/kg (PART ABC4)
Single dose MCS110 3 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg
OG002
MCS110 5 mg/kg (PART ABC4)
Single dose MCS110 5 mg/kg. This group included also the subjects who later switch to MCS110 10 mg/kg.
OG003
MCS110 10 mg/kg (PART ABC4)
Secondary
Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion
To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Pharmacodynamic analysis set
Posted
Mean
Standard Deviation
Degree
Week 24/28, Week 104
ID
Title
Description
OG000
MCS110 3 mg/kg (Part BC)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (Part BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)
Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
Secondary
Time to Relapse
Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
Pharmacodynamic analysis set
Posted
Mean
Standard Deviation
Days
Up to Week 104
ID
Title
Description
OG000
MCS110 10mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg
OG001
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG002
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG003
MCS110 10 mg/kg (PART C)
Secondary
Time to Surgery
Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.
Pharmacodynamic analysis set
Posted
Mean
Standard Deviation
Days
Up to Week 104
ID
Title
Description
OG000
MCS110 10mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg
OG001
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG002
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG003
MCS110 10 mg/kg (PART C)
Secondary
Average of Health-Related Quality of Life Questionnaire Score for mHAQ
The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values <0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.
Pharmacodynamic analysis set
Posted
Mean
Standard Deviation
Scores on a scale
up to 104 weeks
ID
Title
Description
OG000
MCS110 3 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Secondary
Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes
Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.
Pharmacodynamic analysis set
Posted
Number
Number of Monocytes
Baseline Up to Week 104
ID
Title
Description
OG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10mg/kg on day 1 administered by regular infusion.
OG001
MCS110 10 mg/kg (PART B)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group also included participants who had received placebo as a 1st dose
OG002
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG003
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/k. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
Secondary
Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Secondary
Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire
The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).
Pharmacodynamic analysis set
Posted
Mean
Standard Deviation
Score on a scale
Week 4, Week 24, up to 104 weeks
ID
Title
Description
OG000
MCS110 3 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG001
MCS110 5 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG002
MCS110 10 mg/kg (Part BC)
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Time Frame
Treatment-emergent adverse events .Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2 years.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MCS110 10 mg/kg (PART A)
Participants received a single dose of 10 mg/kg on Day 1 administered by i.v. infusion
0
5
0
5
3
5
EG001
Placebo (PART A)
Participants received single dose placebo by i.v. infusion to match MCS110 10 mg/kg
0
2
1
2
1
2
EG002
MCS110 10mg/kg (PART B)
MCS110 10 mg/kg (i.v. infusion)
0
11
2
11
11
11
EG003
Placebo/10mg/kg (PART B)
Participants received single dose placebo to match first dose of MCS110 10 mg/kg and then continued with monthly administration of MCS110 10 mg/kg. fter this first single dose of placebo participants switched to monthly administration of MCS110 10 mg/kg and were added to the MCS110 10 mg/kg (PART B) group, which then increased from 8 to 11 participants. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
0
3
0
3
3
3
EG004
MCS110 3mg/kg (PART C)
MCS110 3 mg/kg (i.v. infusion)
0
7
3
7
7
7
EG005
MCS110 5mg/kg (PART C)
MCS110 5 mg/kg (i.v. infusion)
0
7
1
7
6
7
EG006
MCS110 10mg/kg (PART C)
MCS110 10 mg/kg (i.v. infusion)
0
12
4
12
11
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG0030 affected3 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected12 at risk
Oesophageal spasm
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Gait disturbance
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected2 at risk
EG0020 affected11 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Meningoencephalitis viral
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Viral infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Electrocardiogram ST segment depression
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Device dislocation
Product Issues
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG0030 affected3 at risk
EG004
Leukopenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Blepharitis
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Dark circles under eyes
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Eye swelling
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0023 affected11 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Papilloedema
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected2 at risk
EG0025 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0023 affected11 at risk
EG003
Administration site rash
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Chills
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Face oedema
General disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Infusion site pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Pain
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0023 affected11 at risk
EG003
Soft tissue inflammation
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Swelling
General disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Peritonsillitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Viral infection
Infections and infestations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Amylase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Antinuclear antibody positive
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0011 affected2 at risk
EG0024 affected11 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Blood pressure increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Lipase increased
Investigations
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Benign joint neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Migraine
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0023 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0024 affected11 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Skin wrinkling
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0023 affected11 at risk
EG003
Hot flush
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0021 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected2 at risk
EG0022 affected11 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.1)
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected2 at risk
EG0020 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0007
OG0017
OG00215
OG0034
OG0044
Title
Denominators
Categories
Title
Measurements
OG000-2450.3± 2721.24
OG001-29164.3± 23286.18
OG002-37015.1± 29297.02
OG003-42420.1± 63812.69
OG004-3571.9± 3612.97
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (Part BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (Part BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0007
OG0017
OG00215
OG0034
OG0044
Title
Denominators
Categories
Title
Measurements
OG000-29.7± 33.73
OG001-56.3± 20.31
OG002-55.0± 19.02
OG003-45.8± 40.11
OG004-22.6± 16.21
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG005
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG006
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. This group includes also participants who had received before 3 monthly doses of 3 or 5 mg/kg and then switched to MCS110 10 mg/kg
Units
Counts
Participants
OG0005
OG0012
OG00211
OG0033
OG0047
OG0057
OG00612
Title
Denominators
Categories
AEs of mild severity
Title
Measurements
OG0003
OG0011
OG00211
OG0031
OG0047
OG0056
OG00611
AEs of moderate severity
Title
Measurements
OG0001
OG0011
OG0029
OG003
AEs of severe severity
Title
Measurements
OG0000
OG0010
OG0024
OG003
Study drug related AEs
Title
Measurements
OG0003
OG0011
OG00210
OG003
Serious AEs
Title
Measurements
OG0000
OG0011
OG0022
OG003
AEs leading to discontinuation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG004
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG005
MCS110 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Units
Counts
Participants
OG0005
OG0018
OG0023
OG0036
OG0047
OG0054
Title
Denominators
Categories
Day 1
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0054
Title
Measurements
OG00075632187± 16664282
OG00144258092± 6489002
OG00312900096± 2373049
OG004
Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0030
Day 85
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
Day 112
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0030
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG004
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG005
MCS110 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Units
Counts
Participants
OG0005
OG0018
OG0023
OG0036
OG0047
OG0054
Title
Denominators
Categories
Day 1
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0053
Title
Measurements
OG000234800± 40598
OG001206750± 32745
OG00366983± 8493
OG004
Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0030
Day 85
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Day 112
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG004
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG005
MCS110 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Units
Counts
Participants
OG0005
OG0018
OG0023
OG0036
OG0047
OG0054
Title
Denominators
Categories
Day 1
ParticipantsOG0005
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0036
ParticipantsOG0047
ParticipantsOG0054
Title
Measurements
OG0002.083(1.083 to 3.083)
OG0011.192(1 to 5.05)
OG0033.125(1.083 to 5.083)
OG004
Day 29
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0030
Day 85
ParticipantsOG0000
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Day 112
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0030
OG004
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
OG005
MCS110 5 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 5 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again
OG006
MCS110 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg. Participants could receive a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor growth again
Units
Counts
Participants
OG0005
OG0012
OG0028
OG0033
OG0046
OG0057
OG0064
Title
Denominators
Categories
Baseline
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0033
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0063
Title
Measurements
OG0004694.0± 1375.40
OG0014940.0± 650.54
OG0025767.1± 1159.12
OG003
Day 1
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0033
Day 85
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0033
Day 169
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0033
OG002
MCS110 10 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
Units
Counts
Participants
OG00017
OG0015
OG00217
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG0015
ParticipantsOG00210
Title
Measurements
OG0000.3(0.2 to 0.5)
OG0010.5(0.4 to 1.0)
OG0020.4(0.2 to 0.6)
Week 4
ParticipantsOG00011
ParticipantsOG0015
ParticipantsOG00210
Title
Measurements
OG000
Week 24
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
Title
Measurements
OG002
Week 104
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0025
Title
Measurements
OG002
OG004
MCS110 3 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 3 mg/kg
OG005
MCS110 5 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 5 mg/kg
OG006
MCS110 10 mg/kg (Part C)
Participants received multiple monthly doses of MCS110 10 mg/kg
OG007
MCS110 3 mg/kg & MCS110 10mg/kg (Part C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of participants who started with a dose of 3 mg/kg. Participants could have received a 2nd treatment cycle (6 x 10 mg/kg MCS110) if tumor grew again.
OG008
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
Units
Counts
Participants
OG0005
OG0012
OG0028
OG0033
OG0043
OG0054
OG0064
OG0074
OG0084
Title
Denominators
Categories
Baseline
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0028
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0084
Title
Measurements
OG0005
OG0011
OG0028
OG003
Day 29
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0028
ParticipantsOG0033
Day 85
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0033
Day 127
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Day 169
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0031
Day 336
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0027
ParticipantsOG0030
Day 393
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 505
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Single dose MCS110 10 mg/kg
Units
Counts
Participants
OG0005
OG0017
OG0027
OG00317
Title
Denominators
Categories
Knee Extension
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0039
Title
Measurements
OG000-7.3± 4.99
OG001-12.3± 13.65
OG0021.7± 2.89
OG003
Knee Flexion
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0039
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0007
OG0017
OG00215
OG0034
OG0044
Title
Denominators
Categories
Week 24/28: Knee extension
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
ParticipantsOG0043
Title
Measurements
OG000-10.0± 0.00
OG0010.0± 0.0
OG002-10.5± 21.36
OG003
Week 24/28:(Knee Flexion)
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 104:(Knee Extension)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0028
ParticipantsOG0031
Week 104: (Knee Flexion)
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0028
ParticipantsOG0031
OG002
MCS110 10 mg/kg (PART BC)
Participants received multiple monthly doses of MCS110 10 mg/kg. This included patients who started with single dose placebo, then switched to MCS110 10mg/kg after they switched to MCS110 10mg/kg and had their baseline re-calculated.
OG003
MCS110 3 mg/kg & MCS110 10 mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10 mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0034
ParticipantsOG0044
Title
Measurements
OG00032± 4.24
OG0019.3± 12.74
OG00228.6± 21.82
OG003
Week 4
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0034
Week 12
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG00213
ParticipantsOG0034
Week 24
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00212
ParticipantsOG0033
Week 28
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0034
Week 40
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0034
Week 48
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0030
Week 104
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0034
Participants received multiple monthly doses of MCS110 10 mg/kg
OG004
MCS110 3/10 mg/kg (PART C)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses
OG005
MCS110 5/10 mg/kg (PART C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG00011
OG0013
OG0023
OG0034
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG000337.0± 108.89
OG001454.0± 0
OG002477.0± 0
OG003296.0± 103.24
OG004NA± NAN/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
OG005NA± NAN/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
Participants received multiple monthly doses of MCS110 10 mg/kg
OG004
MCS110 3/10 mg/kg (PART C)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses
OG005
MCS110 5/10 mg/kg (PART C)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG00011
OG0013
OG0023
OG0033
OG0044
OG0054
Title
Denominators
Categories
Title
Measurements
OG000387.0± 116.25
OG0010± 0
OG0020± 0
OG003231.0± 0
OG004NA± NANot Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery
OG005NA± NANot Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG00215
ParticipantsOG0034
ParticipantsOG0044
Title
Measurements
OG0000.3± 0.35
OG0010.1± 0.22
OG0020.3± 0.20
OG003
Week 104
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG0034
OG004
MCS110 10 mg/kg (PART C)
Participants received multiple monthly doses of MCS110 10 mg/kg )
OG005
MCS110 3 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 3 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 3 mg/kg
OG006
MCS110 5 mg/kg & MCS110 10mg/kg (PART C)
Participants received 3 doses of 5 mg/kg and if not efficacious (≥45% of tumor volume reduction) could switch to 10 mg/kg. This is a subset of patients who started with a dose of 5 mg/kg
Units
Counts
Participants
OG0005
OG0018
OG0023
OG0033
OG0044
OG0054
OG0064
Title
Denominators
Categories
Title
Measurements
OG000NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
OG001NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
OG002NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done.
OG003NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
OG004NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
OG005NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
OG006NADue to poor quality, high percentage of samples were not analyzed or results did not meet the acceptance criteria. Because of the paucity of CD14+ and CD14+CD16+ monocytes data no meaningful interpretation could be done
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline-ADL
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
ParticipantsOG0042
Title
Measurements
OG00065.4± 3.12
OG00169.1± 0.00
OG00277.3± 7.87
OG003
Week 4-ADL
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 12-ADL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 24-ADL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0031
Week 28-ADL
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0030
Week 40- ADL
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 48-ADL
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Week 72-ADL
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 104- ADL
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0031
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline-Knee
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
ParticipantsOG0042
Title
Measurements
OG00015.6± 13.26
OG00137.5± 0
OG00229.5± 23.23
OG003
Week 4-Knee
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 12-Knee
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 24-Knee
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG0031
Week 28-Knee
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG0031
Week 40- Knee
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 48-Knee
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Week 72-Knee
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 104- Knee
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0031
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
ParticipantsOG0042
Title
Measurements
OG00054.2± 5.89
OG00152.8± 0
OG00262.6± 17.50
OG003
Week 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 12
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 24
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG0031
Week 28
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 40
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Week 72
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 104
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0031
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
ParticipantsOG0042
Title
Measurements
OG00035.0± 7.07
OG00125.0± 0
OG00229.5± 23.15
OG003
Week 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 12
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 24
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG0031
Week 28
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 40
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Week 72
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 104
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0031
Participants received multiple monthly doses of MCS110 10 mg/kg
OG003
MCS110 3 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 3 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)
Units
Counts
Participants
OG0003
OG0013
OG00215
OG0034
OG0044
Title
Denominators
Categories
Baseline
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
ParticipantsOG0042
Title
Measurements
OG00041.1± 12.63
OG00150.0± 0
OG00250.0± 16.44
OG003
Week 4
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG0031
Week 12
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 24
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0029
ParticipantsOG0031
Week 28
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 40
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0028
ParticipantsOG0030
Week 72
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG00210
ParticipantsOG0031
Week 104
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0027
ParticipantsOG0031
OG004
MCS110 5 mg/kg & MCS110 10mg/kg (PART BC)
Participants received 3 monthly doses of 5 mg/kg and switched to monthly doses of 10 mg/kg (max 3 doses)