Trial Outcomes & Findings for Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29) (NCT NCT02844075)
NCT ID: NCT02844075
Last Updated: 2024-11-15
Results Overview
The primary endpoint of phase II study is to assess complete pathologic response rate. Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=28 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=28 Participants
|
|
Age, Continuous
|
60 years
n=28 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=28 Participants
|
|
Region of Enrollment
South Korea
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Underwent surgery
The primary endpoint of phase II study is to assess complete pathologic response rate. Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
Outcome measures
| Measure |
Pembrolizumab
n=26 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Complete Pathologic Response Rate
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Underwent surgery
Disease free survival is defined from the time of surgery to initial replace or death.
Outcome measures
| Measure |
Pembrolizumab
n=26 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Disease Free Survival
|
17.9 months
Interval 0.9 to 27.6
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Enrollment
Overall survival is defined from the time of enrollment to death or last follow-up date.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Overall Survival
|
33.6 months
Interval 23.8 to 36.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Underwent surgery
Pathologic response rate is defined as tumor regression score. A score of '0' means 'No cancer cell, including lymph nodes'. A score of '1' means 'Single cells or small groups of cancer cells'. A score of '2' means 'Residual cancer cells outgrown by fibrosis'. A score of '3' means 'Minimum or no treatment effect'.
Outcome measures
| Measure |
Pembrolizumab
n=26 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Pathologic Response Rate
Score '0'
|
6 participants
|
|
Pathologic Response Rate
Score '1'
|
10 participants
|
|
Pathologic Response Rate
Score '2'
|
10 participants
|
|
Pathologic Response Rate
Score '3'
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Enrollment
Grade 3-4 adverse events occurring during the neoadjuvant period (no death)
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Safety According to Common Terminology Criteria for Adverse Events (CTCAE) 4.03
|
25 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Enrollment
Event free survival is defined from the time of enrollment to 'event' included disease recurrence.
Outcome measures
| Measure |
Pembrolizumab
n=28 Participants
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Event Free Survival
|
11.0 months
Interval 0.9 to 27.6
|
Adverse Events
Pembrolizumab
Serious events: 10 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=28 participants at risk
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
General disorders
Fatigue
|
7.1%
2/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Nervous system disorders
General weakness
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
4/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Endocrine disorders
Hypothyroidism
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
Other adverse events
| Measure |
Pembrolizumab
n=28 participants at risk
MK-3475(pembrolizumab): Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
14/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Nausea
|
25.0%
7/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Esophagitis
|
21.4%
6/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.4%
6/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
4/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
General disorders
Fatigue
|
39.3%
11/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
General disorders
General weakness
|
14.3%
4/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
4/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
32.1%
9/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
4/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Investigations
Weight loss
|
10.7%
3/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Gastrointestinal disorders
Colitis
|
25.0%
7/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Endocrine disorders
Hypothyroidism
|
10.7%
3/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
2/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
|
Hepatobiliary disorders
Hepatitis
|
28.6%
8/28 • During Neoadjuvant and Adjuvant Period (Up to 3.0 years) - Received neoadjuvant chemoradiotherapy with pembrolizumab - (Underwent surgery) Adjuvant pembrolizumab
according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place