Trial Outcomes & Findings for Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI (NCT NCT01425749)
NCT ID: NCT01425749
Last Updated: 2016-04-04
Results Overview
grade 2 treatment-related adverse events graded by CTCAE v4
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Over 6 months
Results posted on
2016-04-04
Participant Flow
Participant milestones
| Measure |
Arm A: Intramuscular Injections
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B: Intradermal/Subcutaneous Injections
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A: Intramuscular Injections
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B: Intradermal/Subcutaneous Injections
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Overall Study
progression of melanoma
|
0
|
1
|
Baseline Characteristics
Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI
Baseline characteristics by cohort
| Measure |
Arm A
n=13 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=12 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
54 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Stage of Melanoma
Stage IIIB
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Stage of Melanoma
Stage IIIC
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Stage of Melanoma
Stage IV
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Over 6 monthsPopulation: All eligible patients.
grade 2 treatment-related adverse events graded by CTCAE v4
Outcome measures
| Measure |
Arm A
n=13 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=12 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Chills
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Fatigue
|
4 participants
|
2 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Fever
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Flu-like symptoms
|
1 participants
|
2 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Injection site reaction
|
10 participants
|
7 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
Wound complication
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
lymphocyte count decreased
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability
grade 3 or higher adverse events
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: One week after 3 doses of study drug, on day 22.Population: Eligible participants with evaluable sentinel immunized node specimens.
Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.
Outcome measures
| Measure |
Arm A
n=13 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=11 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.
CD4+ T cell response
|
4 participants
|
7 participants
|
|
Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.
CD8+ T cell response
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Over 6 monthsPopulation: All eligible patients with evaluable peripheral blood mononuclear cells; this corresponds to all enrolled patients.
The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.
Outcome measures
| Measure |
Arm A
n=13 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=12 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.
CD4+ T cell response
|
4 participants
|
6 participants
|
|
Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.
CD8+ T cell response
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Over 6 months, typically weeks 1, 7, 13, 26Population: All eligible participants.
Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (\>20 EU/ml).
Outcome measures
| Measure |
Arm A
n=13 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=12 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Seropositivity week 1
|
38 percentage of evaluable participantes
|
8 percentage of evaluable participantes
|
|
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Seropositivity week 0
|
8 percentage of evaluable participantes
|
0 percentage of evaluable participantes
|
|
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Seropositivity week 7
|
100 percentage of evaluable participantes
|
100 percentage of evaluable participantes
|
|
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Seropositivity week 13
|
100 percentage of evaluable participantes
|
100 percentage of evaluable participantes
|
|
Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.
Seropositivity week 26
|
100 percentage of evaluable participantes
|
100 percentage of evaluable participantes
|
SECONDARY outcome
Timeframe: Over 3 weeksPopulation: Evaluable patients with sufficient node sample for the analysis of DC infiltrates.
Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm\^2 in cross-sections of sentinel immunized nodes
Outcome measures
| Measure |
Arm A
n=11 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=11 Participants
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.
CD83+ cells
|
10 cells per mm^2 in SIN
Standard Deviation 14
|
9 cells per mm^2 in SIN
Standard Deviation 13
|
|
Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.
CD1a+
|
42 cells per mm^2 in SIN
Standard Deviation 33
|
28 cells per mm^2 in SIN
Standard Deviation 21
|
SECONDARY outcome
Timeframe: Over 6 monthsPopulation: Participants enrolled on Arm B who had sufficient biopsy site samples.
Cells per mm\^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.
Outcome measures
| Measure |
Arm A
n=11 Participants
Intramuscular injections.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD8 T cells, week 1
|
129 cells per mm^2 of dermis
Standard Deviation 81.6
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD4 T cells, week 1
|
203.6 cells per mm^2 of dermis
Standard Deviation 168.8
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD1a+ cells, week 1
|
10.9 cells per mm^2 of dermis
Standard Deviation 13.8
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD83+ cells, week 1
|
12.6 cells per mm^2 of dermis
Standard Deviation 13.7
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
FoxP3+ cells, week 1
|
43.6 cells per mm^2 of dermis
Standard Deviation 63.3
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Tbet+ cells, week 1
|
53 cells per mm^2 of dermis
Standard Deviation 80.4
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
GATA3+ cells, week 1
|
85.6 cells per mm^2 of dermis
Standard Deviation 73.2
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
RORgamma-t + cells, week 1
|
28 cells per mm^2 of dermis
Standard Deviation 46.3
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD20+ cells, week 1
|
3.9 cells per mm^2 of dermis
Standard Deviation 2.9
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Eosinophils, week 1
|
0.0 cells per mm^2 of dermis
Standard Deviation 0.0
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD8+ T cells, week 7
|
99.9 cells per mm^2 of dermis
Standard Deviation 56.9
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD4+ T cells, week 7
|
125.9 cells per mm^2 of dermis
Standard Deviation 103.1
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD1a+ cells, week 7
|
9 cells per mm^2 of dermis
Standard Deviation 8.5
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD83+ cells, week 7
|
7.8 cells per mm^2 of dermis
Standard Deviation 6.7
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
FoxP3+ cells, week 7
|
28.5 cells per mm^2 of dermis
Standard Deviation 21
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Tbet+ cells, week 7
|
14.1 cells per mm^2 of dermis
Standard Deviation 8.5
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
GATA3+ cells, week 7
|
41.3 cells per mm^2 of dermis
Standard Deviation 21.1
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
RORgammat+ cells, week 7
|
7.8 cells per mm^2 of dermis
Standard Deviation 6.1
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
CD20+ cells, week 7
|
6.5 cells per mm^2 of dermis
Standard Deviation 7.1
|
—
|
|
A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).
Eosinophils, week 7
|
0.1 cells per mm^2 of dermis
Standard Deviation 0.2
|
—
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A
n=13 participants at risk
Intramuscular injections of recMAGE-A3 + AS15 ASCI.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
Arm B
n=12 participants at risk
Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.
recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Gastrointestinal disorders
Mucositis Oral
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
25.0%
3/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
Chills
|
69.2%
9/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
33.3%
4/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
Fatigue
|
92.3%
12/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
100.0%
12/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
Fever
|
30.8%
4/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
41.7%
5/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
Flu-like symptoms
|
46.2%
6/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
58.3%
7/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
injection site reaction
|
100.0%
13/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
100.0%
12/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
localized edema
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
other
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
General disorders
Autoimmune disorder
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Injury, poisoning and procedural complications
seroma
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Investigations
lymphocyte count decreased
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Metabolism and nutrition disorders
anorexia
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
53.8%
7/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
33.3%
4/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
38.5%
5/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
41.7%
5/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Nervous system disorders
dizziness
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
16.7%
2/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Nervous system disorders
headache
|
38.5%
5/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
25.0%
3/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Nervous system disorders
tremor
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Psychiatric disorders
agitation
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Psychiatric disorders
depression
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
15.4%
2/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
16.7%
2/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Skin and subcutaneous tissue disorders
pain of skin
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
16.7%
2/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Skin and subcutaneous tissue disorders
skin induration
|
7.7%
1/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
0.00%
0/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Skin and subcutaneous tissue disorders
other
|
0.00%
0/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Vascular disorders
flushing
|
23.1%
3/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
8.3%
1/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
|
Vascular disorders
hot flashes
|
30.8%
4/13 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
16.7%
2/12 • 6 months
Treatment-related adverse events (AEs) were recorded. At each clinic visit, each patient was completely evaluated by a licensed clinician, for physical exam and history and review of toxicity diaries. Additional AEs were captured from laboratory tests. Grade 2 AEs are listed under primary endpoint. AEs of grade 3 or higher are reported here (none).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place