Trial Outcomes & Findings for NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer (NCT NCT03734809)
NCT ID: NCT03734809
Last Updated: 2025-12-24
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), including * Increase in the sum of diameters of target lesion(s) identified at baseline to ≥ 20% and ≥ 5 mm from nadir * Unequivocal progression of non-target lesion(s) identified at baseline * Development of new lesion(s)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
2 years
Results posted on
2025-12-24
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NEO-SPACE Trial: Pembrolizumab and Chemoradiation in Nasopharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
Singapore
|
14 participants
n=30 Participants
|
|
Region of Enrollment
Hong Kong
|
29 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 2 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), including * Increase in the sum of diameters of target lesion(s) identified at baseline to ≥ 20% and ≥ 5 mm from nadir * Unequivocal progression of non-target lesion(s) identified at baseline * Development of new lesion(s)
Outcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Two-year Progression Free Survival
|
73.8 percentage of participants
Interval 60.5 to 87.1
|
SECONDARY outcome
Timeframe: during the first yearuse toxicity chart to capture
Outcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Grade 4 Mucositis/Skin Reaction or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year
|
0 participants
|
SECONDARY outcome
Timeframe: after the first year, up to 24 monthsOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Grade 4 Mucositis/Skin Reaction or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment Occurring After the First Year
|
0 participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Chemotherapy - neoadjuvant phase
|
98.0 percentage of participants
|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Chemotherapy - Concurrent phase
|
73.1 percentage of participants
|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Immunotherapy - neoadjuvant phase
|
100.0 percentage of participants
|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Immunotherapy - Concurrent phase
|
78.3 percentage of participants
|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Immunotherapy - maintenance phase
|
78.1 percentage of participants
|
|
Patient Tolerability to Each Component (Neoadjuvant, Concurrent and Maintenance Part) of the Protocol Treatment Regimen
Radiotherapy
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Other ≥ Grade 3 Adverse Events
Thrombocytopenia
|
10.8 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Dysphagia
|
32.4 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Mucositis
|
29.7 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Neutropenia
|
29.7 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Radiation dermatitis
|
24.3 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Anemia
|
18.9 percentage of participants
|
|
Other ≥ Grade 3 Adverse Events
Hyponatremia
|
13.5 percentage of participants
|
SECONDARY outcome
Timeframe: during or within 30 daysOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Death During or Within 30 Days of Discontinuation of Protocol Treatment
|
0 participants
|
SECONDARY outcome
Timeframe: 1 year and 2 yearsOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
One- and Two-year Distant Metastases Rates
One-year rate of distant metastases
|
95.2 percentage of participants
Interval 88.8 to 100.0
|
|
One- and Two-year Distant Metastases Rates
Two-year rate of distant metastases
|
83.0 percentage of participants
Interval 71.0 to 95.0
|
SECONDARY outcome
Timeframe: 1 year and 2 yearsOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
One- and Two-year Local-regional Progression Rates
One-year rate of local-regional progression
|
95.3 percentage of participants
Interval 88.9 to 100.0
|
|
One- and Two-year Local-regional Progression Rates
Two-year rate of local-regional progression
|
90.4 percentage of participants
Interval 81.5 to 99.3
|
SECONDARY outcome
Timeframe: 1 year and 2 yearsOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
One- and Two-year Rates of Second Primary Cancer
Two-year rate of secondary primary
|
97.5 percentage of participants
Interval 92.6 to 100.0
|
|
One- and Two-year Rates of Second Primary Cancer
One-year rate of secondary primary
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 year and 2 yearsOutcome measures
| Measure |
Pembrolizumab
n=43 Participants
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
One- and Two-year Overall Survival Rates
One-year rate of overall survival
|
97.6 percentage of participants
Interval 93.0 to 100.0
|
|
One- and Two-year Overall Survival Rates
Two-year rate of overall survivial
|
92.9 percentage of participants
Interval 85.1 to 100.0
|
Adverse Events
Pembrolizumab
Serious events: 17 serious events
Other events: 32 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=43 participants at risk
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Thromboembolic event - Pulmonary Embolism
|
2.3%
1/43 • 4 years
|
|
General disorders
Neck edema
|
2.3%
1/43 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 infection
|
2.3%
1/43 • 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • 4 years
|
|
General disorders
Hypothermia
|
2.3%
1/43 • 4 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
2.3%
1/43 • 4 years
|
|
General disorders
Fever
|
14.0%
6/43 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
7.0%
3/43 • 4 years
|
|
Gastrointestinal disorders
Infections and infestations - Other
|
4.7%
2/43 • 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
1/43 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.7%
2/43 • 4 years
|
|
General disorders
Fatigue
|
2.3%
1/43 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/43 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/43 • 4 years
|
|
Renal and urinary disorders
Proteinuria
|
2.3%
1/43 • 4 years
|
|
Immune system disorders
Sepsis
|
2.3%
1/43 • 4 years
|
|
Gastrointestinal disorders
Alkaline phosphataseincrease
|
2.3%
1/43 • 4 years
|
|
Psychiatric disorders
Relapse of mania
|
2.3%
1/43 • 4 years
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
2.3%
1/43 • 4 years
|
|
Gastrointestinal disorders
Odynophagia
|
2.3%
1/43 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • 4 years
|
Other adverse events
| Measure |
Pembrolizumab
n=43 participants at risk
Total 51 weeks for 17 doses of pembrolizumab:
* Neoadjuvant pembrolizumab-chemotherapy: 6 weeks (2 doses of pembrolizumab)
* Concurrent pembrolizumab-chemoradiation: 9 weeks (3 doses of pembrolizumab
* Maintenance pembrolizumab: 36 weeks (12 doses of pembrolizumab)
Pembrolizumab: 200mg every 3 weeks infusion
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
32.6%
14/43 • 4 years
|
|
Gastrointestinal disorders
Mucositis
|
30.2%
13/43 • 4 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.2%
13/43 • 4 years
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
23.3%
10/43 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
18.6%
8/43 • 4 years
|
|
Blood and lymphatic system disorders
Hyponatremia
|
14.0%
6/43 • 4 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.3%
4/43 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place