Trial Outcomes & Findings for Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy (NCT NCT02971748)
NCT ID: NCT02971748
Last Updated: 2026-01-22
Results Overview
Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From treatment initiation through last available follow-up (up to approximately 9 years)
Results posted on
2026-01-22
Participant Flow
Mar 2017\~ Sept 2025. All recruitment was done at The University of Texas MD Anderson Cancer Center.
36 patients were accrued and assessed for eligibility and 31 patients were assigned to the cohort.
Participant milestones
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Financial issue
|
2
|
|
Overall Study
Clinical progression
|
8
|
Baseline Characteristics
Pembrolizumab in Treating Patients With Hormone Receptor Positive, Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
n=31 Participants
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=270 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=270 Participants
|
PRIMARY outcome
Timeframe: From treatment initiation through last available follow-up (up to approximately 9 years)Population: All treated patients were included in the DFS analysis.
Disease-free survival (DFS) is defined as the time from treatment initiation to recurrence of disease or death from any cause. Patients without an event were censored at their last disease assessment.
Outcome measures
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
n=31 Participants
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Disease Free Survival (DFS)
|
4.22 years
Interval 2.17 to
The upper confidence limit was not estimable because insufficient progression events occurred after the median time point.
|
PRIMARY outcome
Timeframe: From first dose through 30 days after last dose (up to approximately 25 months)Population: All treated patients were included in the safety analysis.
Number of participants experiencing treatment-related adverse events, graded according to CTCAE v4.0.
Outcome measures
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
n=31 Participants
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Participants With Treatment-Related Adverse Events
Abdominal pain
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Alanine aminotransferase increased
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Anorexia
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Arthralgia
|
7 Participants
|
|
Participants With Treatment-Related Adverse Events
Aspartate aminotransferase increased
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Colitis
|
4 Participants
|
|
Participants With Treatment-Related Adverse Events
Cough
|
2 Participants
|
|
Participants With Treatment-Related Adverse Events
Diarrhea
|
3 Participants
|
|
Participants With Treatment-Related Adverse Events
Dry mouth
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Dyspnea
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Esophagitis
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Fatigue
|
7 Participants
|
|
Participants With Treatment-Related Adverse Events
Hyperglycemia
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Hyperkalemia
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Hypertriglyceridemia
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Hypothyroidism
|
9 Participants
|
|
Participants With Treatment-Related Adverse Events
Positive ANA antibody
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Joint effusion
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Lymphocyte count decreased
|
2 Participants
|
|
Participants With Treatment-Related Adverse Events
Myalgia
|
2 Participants
|
|
Participants With Treatment-Related Adverse Events
Nausea
|
3 Participants
|
|
Participants With Treatment-Related Adverse Events
Osteoporosis
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Palmar-plantar erythrodysesthesia syndrome
|
1 Participants
|
|
Participants With Treatment-Related Adverse Events
Pneumonitis
|
4 Participants
|
|
Participants With Treatment-Related Adverse Events
Pruritus
|
2 Participants
|
|
Participants With Treatment-Related Adverse Events
Rash maculo-papular
|
3 Participants
|
|
Participants With Treatment-Related Adverse Events
Urinary tract infection
|
1 Participants
|
Adverse Events
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
Serious events: 6 serious events
Other events: 28 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
n=31 participants at risk
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
Other adverse events
| Measure |
Pembrolizumab + Hormonal Therapy for HR+ Localized IBC Without pCR After Neoadjuvant Chemo
n=31 participants at risk
Pembrolizumab 200 mg every 3 weeks with hormonal therapy per physician discretion.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
29.0%
9/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Eye disorders
Eye pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Eye disorders
Retinal vascular disorder
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Bloating
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Colitis
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
3/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Esophagitis
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
6/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
General disorders
Fatigue
|
29.0%
9/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
General disorders
Flu like symptoms
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
General disorders
Malaise
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
General disorders
Pain
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Immune system disorders
Positive ANA antibody
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Bladder infection
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Bronchial infection
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Enterocolitis infectious
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
COVID-19 infection
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Gastroenteritis viral
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Skin infection
|
12.9%
4/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Tooth infection
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Upper respiratory infection
|
12.9%
4/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Injury, poisoning and procedural complications
Fracture
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Blood bilirubin increased
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
INR increased
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Lymphocyte count decreased
|
9.7%
3/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Weight gain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Investigations
Weight loss
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.5%
11/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.1%
5/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Cognitive disturbance
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Headache
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Balance difficulty
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Paresthesia
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Nervous system disorders
Tremor
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Psychiatric disorders
Confusion
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Psychiatric disorders
Insomnia
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
3/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.5%
2/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.9%
4/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Vascular disorders
Hypertension
|
29.0%
9/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • All-cause mortality was assessed for up to 2 years after treatment discontinuation. Adverse events were assessed from first protocol-specific intervention through 30 days after last pembrolizumab dose (up to approximately 25 months)
Adverse events were assessed using CTCAE v4.0. All AEs of ≥ Grade 2 for non-hematologic events and ≥ Grade 3 for hematologic events, regardless of attribution, were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place