Trial Outcomes & Findings for Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED) (NCT NCT03064490)
NCT ID: NCT03064490
Last Updated: 2025-04-10
Results Overview
A two-stage design will be used to test the null hypothesis that the true pCR rate is ≤ 0.30 against the alternative hypothesis that the true pCR rate is ≥ 0.50. This design will allow the trial to stop early to accept the null hypothesis. If there are no more than 4 responders (27%) in the first 15 evaluable patients, the trial will stop to accept the null. Otherwise, an additional 15 evaluable patients will be accrued.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
up to 20 weeks
Results posted on
2025-04-10
Participant Flow
Participant milestones
| Measure |
Single Arm Interventional Study
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Single Arm Interventional Study
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)
Baseline characteristics by cohort
| Measure |
Single Arm Interventional Study
n=35 Participants
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 20 weeksA two-stage design will be used to test the null hypothesis that the true pCR rate is ≤ 0.30 against the alternative hypothesis that the true pCR rate is ≥ 0.50. This design will allow the trial to stop early to accept the null hypothesis. If there are no more than 4 responders (27%) in the first 15 evaluable patients, the trial will stop to accept the null. Otherwise, an additional 15 evaluable patients will be accrued.
Outcome measures
| Measure |
Single Arm Interventional Study
n=30 Participants
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR)
|
11 Participants
|
SECONDARY outcome
Timeframe: Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapyThe number of Grade 3+ non-hematological adverse events of special interest that occurred will be reported.
Outcome measures
| Measure |
Single Arm Interventional Study
n=34 Participants
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Fall
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Weight loss
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Rash
|
6 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Esophagitis
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Lung infection
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Dyspnea
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Pneumonitis
|
3 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Esophageal pain
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Thrombolytic event
|
3 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Hyponatremia
|
6 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Fever
|
4 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Aspartate aminotransferase increased
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Blood bilirubin increased
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Diarrhea
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Colitis
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Dehydration
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Vasovagal reaction
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Syncope
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Glucose intolerance
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Fatigue
|
2 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Infection
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Sinus tachycardia
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Hypoxia
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
Investigation, other
|
1 events
|
|
Safety of the Combined Drug Therapy With Radiation Therapy
GI disorder, other
|
1 events
|
Adverse Events
Single Arm Interventional Study
Serious events: 15 serious events
Other events: 33 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Single Arm Interventional Study
n=35 participants at risk
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Injury, poisoning and procedural complications
Gastric anastomotic leak
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Colitis
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Injury, poisoning and procedural complications
Esophageal anastomotic leak
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Esophagitis
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Fever
|
8.6%
3/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Immune system disorders
Autoimmune disorder
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Lung Infection
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Sepsis
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Wound infection
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.1%
6/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Pleural infection
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Vascular disorders
Thromboembolic event
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Aspartate aminotransferase increased
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Upper respiratory infection
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
White blood cell decreased
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Investigations - Other, specify
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Lethargy
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Psychiatric disorders
Confusion
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.1%
6/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Esophageal pain
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Vasovagal reaction
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Infection
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Weight loss
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Investigations, other
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
GI disorder, other
|
2.9%
1/35 • Number of events 1 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
Other adverse events
| Measure |
Single Arm Interventional Study
n=35 participants at risk
Single arm, non randomized, open label study. Subjects will receive three doses of neoadjuvant pembrolizumab (200 mg administered as an intravenous infusion over 30 minutes every 3 weeks). Pembrolizumab will be administered with weekly standard of care Carboplatin/Paclitaxel concurrent chemo-radiation therapy in the neo-adjuvant setting. Postoperatively, three additional cycles of pembrolizumab (200 mg every 3 weeks) will be administered as adjuvant therapy.
Pembrolizumab: Neoadjuvant Pembrolizumab ( 3 cycles) administered concurrently with weekly Carboplatin and Paclitaxel and daily radiation therapy; followed by surgical resection and adjuvant Pembrolizumab ( 3 cycles)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
94.3%
33/35 • Number of events 51 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Cardiac disorders
Chest pain - cardiac
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Cardiac disorders
Sinus tachycardia
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Endocrine disorders
Hyperthyroidism
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Endocrine disorders
Hypothyroidism
|
22.9%
8/35 • Number of events 9 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Abdominal pain
|
34.3%
12/35 • Number of events 14 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Bloating
|
8.6%
3/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Constipation
|
71.4%
25/35 • Number of events 30 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Diarrhea
|
45.7%
16/35 • Number of events 27 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Dyspepsia
|
17.1%
6/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
7/35 • Number of events 9 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Esophageal pain
|
20.0%
7/35 • Number of events 11 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Esophagitis
|
82.9%
29/35 • Number of events 41 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Flatulence
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.4%
4/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
14.3%
5/35 • Number of events 7 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Gastroparesis
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Mucositis oral
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Nausea
|
82.9%
29/35 • Number of events 50 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Oral pain
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
20/35 • Number of events 31 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Chills
|
17.1%
6/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Edema limbs
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Fatigue
|
94.3%
33/35 • Number of events 53 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Fever
|
25.7%
9/35 • Number of events 17 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Infusion related reaction
|
14.3%
5/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
General disorders
Pain
|
25.7%
9/35 • Number of events 12 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Immune system disorders
Allergic reaction
|
28.6%
10/35 • Number of events 10 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Bronchial infection
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Infections and infestations - Other, specify
|
14.3%
5/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Lung infection
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Phlebitis infective
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Rash pustular
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Skin infection
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Infections and infestations
Urinary tract infection
|
11.4%
4/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
14.3%
5/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Aspartate aminotransferase increased
|
17.1%
6/35 • Number of events 13 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Lymphocyte count decreased
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Neutrophil count decreased
|
54.3%
19/35 • Number of events 31 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Platelet count decreased
|
68.6%
24/35 • Number of events 43 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
White blood cell decreased
|
68.6%
24/35 • Number of events 49 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Blood and lymphatic system disorders - Other, specify
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Alanine aminotransferase increased
|
22.9%
8/35 • Number of events 13 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
7/35 • Number of events 8 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Blood bilirubin increased
|
14.3%
5/35 • Number of events 8 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Creatinine increased
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Investigations - Other, specify
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Investigations
Weight loss
|
57.1%
20/35 • Number of events 27 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
10/35 • Number of events 10 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Dehydration
|
54.3%
19/35 • Number of events 54 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
57.1%
20/35 • Number of events 29 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
5/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.7%
2/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.4%
11/35 • Number of events 18 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.1%
6/35 • Number of events 7 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Hyponatremia
|
77.1%
27/35 • Number of events 58 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.7%
2/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
5/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Dizziness
|
37.1%
13/35 • Number of events 14 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Dysgeusia
|
8.6%
3/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Headache
|
20.0%
7/35 • Number of events 9 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
8.6%
3/35 • Number of events 3 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Paresthesia
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.6%
3/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Renal and urinary disorders
Hematuria
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
11.4%
4/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Renal and urinary disorders
Urinary tract pain
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
62.9%
22/35 • Number of events 33 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.4%
11/35 • Number of events 18 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.9%
8/35 • Number of events 9 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
5/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.4%
4/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Number of events 4 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
42.9%
15/35 • Number of events 32 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
17.1%
6/35 • Number of events 6 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Vascular disorders
Flushing
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Number of events 5 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Cardiac disorders
Atrial fibrillation
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
2/35 • Number of events 2 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
48.6%
17/35 • Number of events 23 • Neoadjuvant: from the start of neoadjuvant therapy until surgery, approximately 20 weeks Postoperative: within 30 days after surgery Adjuvant: from the start of adjuvant therapy until 90 days after the last dose of adjuvant therapy
Serious adverse events are defined as Grade 3+ adverse events leading to hospitalization
|
Additional Information
Linda Kaltenbach/Regulatory Coordinator
Duke University Health System (DUHS)
Phone: (919) 668-3726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place