Trial Outcomes & Findings for Breast Cancer Study of Preoperative Pembrolizumab + Radiation (NCT NCT03366844)
NCT ID: NCT03366844
Last Updated: 2025-04-29
Results Overview
Feasibility of preoperative radiation and Pembrolizumab in newly diagnosed, non-metastatic patients with triple negative breast cancer.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
8 weeks after trial initiation
Results posted on
2025-04-29
Participant Flow
The trial opened to accrual on 12/14/2017 with first subject enrolled on study 12/22/2017. A total of 85 patients consented, 10 subjects failed screening, 10 withdrew consent prior to starting study intervention and were replaced. 66 subjects completed study intervention but 6 were deemed unevaluable. Total target accrual of 60 subjects was met with the last subject off treatment as of 01/26/2022. Last data collection for all primary endpoints confirmed on February 6, 2025.
Participant milestones
| Measure |
Pembrolizumab With RT Boost
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
Phase 1b
|
10
|
|
Overall Study
Phase II
|
50
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pembrolizumab With RT Boost
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Unevaluable for co-primary endpoint (did not complete all required biopsies)
|
5
|
Baseline Characteristics
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
Baseline characteristics by cohort
| Measure |
Pembrolizumab With RT Boost
n=60 Participants
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after trial initiationFeasibility of preoperative radiation and Pembrolizumab in newly diagnosed, non-metastatic patients with triple negative breast cancer.
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=60 Participants
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Number of Patients Who do Not Necessitate a Delay in Standard of Care Treatment After Receiving the Investigational Combination of Preoperative Pembrolizumab and Radiation
|
36 Participants
|
—
|
PRIMARY outcome
Timeframe: 8 weeks after trial initiationAn increase in the tumor-infiltrating lymphocyte score (TILs) as measured by Salgado criteria. An increase in TILs is an indicator of immune system engagement (range is 0-100 in percent), therefore increase indicates better outcome. A lead in with pembrolizumab alone followed by the combination of pembrolizumab with RT will allow for serial assessment of TILs. This will establish the contribution of RT to the immune response generated by pembrolizumab. The working group's consensus for Salgado criteria is that TILs may provide more biological relevant information when scored as a continuous variable. The percentage of stromal TILs is a semi quantitative parameter for this assessment (0%-100%). No formal recommendation for a clinically relevant TIL threshold(s) can be given at this stage. The consensus was that a valid methodology is currently more important than issues of thresholds for clinical use, which will be determined once a solid methodology is in place.
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=34 Participants
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
n=9 Participants
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Changes in Tumor Infiltrating Lymphocyte Score (TILs)
|
-6.06 score on a scale
Standard Deviation 29.85
|
-0.11 score on a scale
Standard Deviation 8.68
|
SECONDARY outcome
Timeframe: 15 weeks after trial initiationTreatment toxicities. Number of AEs attributed to Pembrolizumab (considered at least possibly related, probably related, or related).
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=990 Adverse Events (AEs)
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Pembrolizumab-related Adverse Events
|
453 Adverse Events (AEs)
|
—
|
SECONDARY outcome
Timeframe: Assessed up to one year post-treatmentTreatment toxicities. Number of immune-related AEs (irAEs).
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=990 Adverse Eventss (AEs)
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Immune-related Adverse Events
|
17 Adverse Eventss (AEs)
|
—
|
SECONDARY outcome
Timeframe: From treatment start date until date of documented recurrence or death from breast cancer, assessed up to 19 weeks after start of treatmentPopulation: Median survival estimates not applicable at this moment due to lack of events.
Disease-free survival, as described from time from occurrence of surgery to time from first recurrence from or death from breast cancer
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=60 Participants
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Invasive Disease-free Survival After Preoperative Radiation and Pembrolizumab
|
53 Participants
|
—
|
SECONDARY outcome
Timeframe: From treatment start date until the time of curative-intent surgery, approximately 8 weeks.Population: The analysis population includes patients starting from Phase II so there are a total of 50 evaluable subjects (40 TNBC; 10 HR+).
Absence of invasive disease in the breast and lymph nodes at the time of curative-intent surgery.
Outcome measures
| Measure |
Pembrolizumab With RT Boost
n=40 Participants
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
PembroRT - Cohort: HR+
n=10 Participants
Single Arm with 2 Cohorts: Cohort: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm. All subjects receive pembrolizumab with an RT boost, consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|---|
|
Pathological Complete Response Rate
|
22 Participants
|
3 Participants
|
Adverse Events
Pembrolizumab With RT Boost
Serious events: 3 serious events
Other events: 49 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Pembrolizumab With RT Boost
n=60 participants at risk
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
5.0%
3/60 • Number of events 3 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
2/60 • Number of events 2 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Fever
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Infections and infestations
Lung infection
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Cardiac disorders
Syncope
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Renal and urinary disorders
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
Other adverse events
| Measure |
Pembrolizumab With RT Boost
n=60 participants at risk
Single Arm with 2 Cohorts: Cohort 1: High-risk, ER-positive and HER2-negative breast cancer patients with primary tumors measuring at least 2cm; Cohort 2: TNBC patients with primary tumors measuring at least 2cm. All subjects receive study intervention: pembrolizumab (checkpoint inhibitor) with the second dose of pembrolizumab given in conjunction with an RT boost ("tumor boost"), consisting of 8 Gy for 3 fractions, before standard of care treatment.
|
|---|---|
|
General disorders
Fatigue
|
81.7%
49/60 • Number of events 73 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Nausea
|
81.7%
49/60 • Number of events 64 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Diarrhea
|
48.3%
29/60 • Number of events 41 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Constipation
|
43.3%
26/60 • Number of events 28 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.3%
26/60 • Number of events 26 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
24/60 • Number of events 26 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
24/60 • Number of events 29 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Headache
|
33.3%
20/60 • Number of events 23 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Psychiatric disorders
Insomnia
|
28.3%
17/60 • Number of events 17 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
15/60 • Number of events 16 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.3%
14/60 • Number of events 16 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
23.3%
14/60 • Number of events 14 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
21.7%
13/60 • Number of events 15 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.7%
13/60 • Number of events 17 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.3%
11/60 • Number of events 14 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Dysgeusia
|
18.3%
11/60 • Number of events 12 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.3%
11/60 • Number of events 13 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Number of events 13 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Blood and lymphatic system disorders
Anemia Hemoglobin (Hgb)
|
15.0%
9/60 • Number of events 11 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Reproductive system and breast disorders
Breast pain
|
15.0%
9/60 • Number of events 11 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60 • Number of events 9 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Pain
|
15.0%
9/60 • Number of events 9 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Psychiatric disorders
Anxiety
|
13.3%
8/60 • Number of events 8 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Vascular disorders
Hot flashes
|
13.3%
8/60 • Number of events 9 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
8/60 • Number of events 9 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
11.7%
7/60 • Number of events 8 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.7%
7/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Fever
|
11.7%
7/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
11.7%
7/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Other
|
11.7%
7/60 • Number of events 8 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Paresthesia
|
11.7%
7/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
6/60 • Number of events 6 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
6/60 • Number of events 11 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
6/60 • Number of events 11 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
10.0%
6/60 • Number of events 6 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Chills
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
5/60 • Number of events 6 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.3%
5/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Flu like symptoms
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Investigations
Neutrophil count decreased
|
8.3%
5/60 • Number of events 9 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Other
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
5/60 • Number of events 6 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.3%
5/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Edema limbs
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
4/60 • Number of events 5 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Gastrointestinal disorders
Localized edema
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Nervous system disorders
Other
|
6.7%
4/60 • Number of events 7 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
General disorders
Other
|
6.7%
4/60 • Number of events 6 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Cardiac disorders
Palpitations
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
4/60 • Number of events 4 • From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
From week 1 until week 19 for all AEs, and immune-related AEs (irAEs) up until 1 year post treatment, up to 14 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place