Trial Outcomes & Findings for Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer (NCT NCT04373031)
NCT ID: NCT04373031
Last Updated: 2025-12-02
Results Overview
Number of patients who showed pCR post surgery. pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Following definitive surgery, approximately 9 months.
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Control
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Control
n=6 Participants
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 Participants
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, median
|
56 years
n=121 Participants
|
55 years
n=122 Participants
|
55.5 years
n=243 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=121 Participants
|
5 Participants
n=122 Participants
|
9 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 0 (Asymptomatic)
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 1 (Symptomatic but completely ambulatory)
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 2 (Symptomatic, <50% in bed during the day)
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 3 (Symptomatic, >50% in bed, but not bedbound)
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 4 (Bedbound)
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Baseline ECOG Performance Status
ECOG PS 5 (Death)
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: Following definitive surgery, approximately 9 months.Number of patients who showed pCR post surgery. pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.
Outcome measures
| Measure |
Control
n=6 Participants
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 Participants
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1 through safety follow-up visit, approximately 9 months.Number of serious adverse events (SAE) reported by patients attributed to study drugs.
Outcome measures
| Measure |
Control
n=6 Participants
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 Participants
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Safety and Tolerability Profile as Assessed by CTCAE v5.0
|
0 Number of Occurrences
|
2 Number of Occurrences
|
SECONDARY outcome
Timeframe: Following definitive surgery, approximately 9 months.Evaluate increase in tumor infiltrating lymphocyte by H\&E (comparing diagnostic biopsy to post-induction biopsy). Tumor infiltrating lymphocytes will be assessed by the San Antonio stromal TIL criteria.
Outcome measures
| Measure |
Control
n=6 Participants
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 Participants
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Percent Change in Tumor Infiltrating Lymphocytes (TIL) Quantity Changes
|
11 percentage change of TIL quantity
Interval -36.0 to 59.0
|
-26 percentage change of TIL quantity
Interval -58.0 to 5.6
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Arm A
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=6 participants at risk
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 participants at risk
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
Other adverse events
| Measure |
Control
n=6 participants at risk
Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
|
Arm A
n=6 participants at risk
• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
Pembrolizumab: Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
IRX 2: IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
50.0%
3/6 • Number of events 5 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Peeling skin
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
2/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
66.7%
4/6 • Number of events 4 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Investigations
Absolute neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
4/6 • Number of events 4 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
50.0%
3/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Nervous system disorders
Anosmia
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg pain
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
50.0%
3/6 • Number of events 5 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Injury, poisoning and procedural complications
Injection site bruising
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
50.0%
3/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Injury, poisoning and procedural complications
Injection site erythema
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Nervous system disorders
Lower leg tingling, intermittent
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Mouth sores
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
33.3%
2/6 • Number of events 2 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Skin and subcutaneous tissue disorders
Nail pain
|
0.00%
0/6 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
16.7%
1/6 • Number of events 1 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
50.0%
3/6 • Number of events 4 • From the start of study treatment through 90 days following the cessation of treatment or the initiation of new anti-cancer therapy (an average of 7 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place