Trial Outcomes & Findings for Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma (NCT NCT03278626)
NCT ID: NCT03278626
Last Updated: 2022-03-28
Results Overview
UT is defined as: 1. Recurrent grade 3 or 4 hematologic toxicity (despite 1 prior dose reduction in chemotherapy) 2. any toxicity that results in a \> 2-week delay in chemoradiation
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
92 days (up to 28 days after Day 64)
Results posted on
2022-03-28
Participant Flow
Participant milestones
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Toxicity
|
1
|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
n=12 Participants
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Age, Continuous
|
63.95 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 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
|
3 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 92 days (up to 28 days after Day 64)UT is defined as: 1. Recurrent grade 3 or 4 hematologic toxicity (despite 1 prior dose reduction in chemotherapy) 2. any toxicity that results in a \> 2-week delay in chemoradiation
Outcome measures
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
n=6 Participants
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Phase 1: Number of Unacceptable Toxicity (UT) Events
|
0 Unacceptable Toxicity Events
|
PRIMARY outcome
Timeframe: 5-8 Weeks post radiation treatment (7-8 months after treatment start)Clinical and pathological response after neoadjuvant therapy cCR by endoscopic + PET/CT evaluation; pCR for patients undergoing surgery Clinical Complete Response (cCR), no malignancy is found on clinical examination, imaging, endoscopy, and biopsy; Pathological Complete Response (pCR), no invasive and no in situ residual tumors in tissue
Outcome measures
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
n=3 Participants
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Phase 2: Number of Subjects Who Achieved cCR (Clinical Complete Response) or pCR (Pathological Complete Response)
|
1 Participants
|
Adverse Events
Nivolimumab+Carboplatin/Paclitaxel+Radiation
Serious events: 6 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
n=12 participants at risk
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Infections and infestations
Lung Infection
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Death
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Fever
|
8.3%
1/12 • 100 days post-treatment
|
|
Psychiatric disorders
Confusion
|
8.3%
1/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
8.3%
1/12 • 100 days post-treatment
|
|
Cardiac disorders
Myocardial Infarction
|
8.3%
1/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash-Morbiliform
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Esophagitis
|
8.3%
1/12 • 100 days post-treatment
|
Other adverse events
| Measure |
Nivolimumab+Carboplatin/Paclitaxel+Radiation
n=12 participants at risk
240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to the standard of care: paclitaxel 50 mg/m2 weekly for 6 weeks and carboplatin AUC 2 weekly for 6 weeks and radiation
Nivolimumab+Carboplatin/paclitaxel+Radiation: In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
3/12 • 100 days post-treatment
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
8.3%
1/12 • 100 days post-treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
25.0%
3/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
1/12 • 100 days post-treatment
|
|
Blood and lymphatic system disorders
Anemia
|
91.7%
11/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
41.7%
5/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia Knee Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
4/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
41.7%
5/12 • 100 days post-treatment
|
|
Nervous system disorders
Ataxia
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Bloating
|
8.3%
1/12 • 100 days post-treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
8.3%
1/12 • 100 days post-treatment
|
|
Cardiac disorders
Chest Pain After Stent
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Colitis
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Constipation
|
50.0%
6/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • 100 days post-treatment
|
|
Investigations
Decreased Lymphocyte Count
|
83.3%
10/12 • 100 days post-treatment
|
|
Investigations
Decreased Neutrophil Count
|
58.3%
7/12 • 100 days post-treatment
|
|
Investigations
Decreased Platelet Count
|
75.0%
9/12 • 100 days post-treatment
|
|
Investigations
Decreased Wbc Count
|
75.0%
9/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
3/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
8.3%
1/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis Radiation
|
16.7%
2/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • 100 days post-treatment
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Dry Mouth
|
25.0%
3/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
1/12 • 100 days post-treatment
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Dysphagia
|
66.7%
8/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Dyspnea
|
25.0%
3/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Esophageal Discomfort
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Esophageal Pain
|
41.7%
5/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Esophagitis
|
41.7%
5/12 • 100 days post-treatment
|
|
General disorders
Fatigue
|
50.0%
6/12 • 100 days post-treatment
|
|
General disorders
Fever
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Flatulence
|
50.0%
6/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
8.3%
1/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
2/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.3%
1/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.7%
5/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
3/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
3/12 • 100 days post-treatment
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
6/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
3/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
3/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
58.3%
7/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
4/12 • 100 days post-treatment
|
|
General disorders
Hyponatremia
|
33.3%
4/12 • 100 days post-treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
3/12 • 100 days post-treatment
|
|
Vascular disorders
Hypotension
|
16.7%
2/12 • 100 days post-treatment
|
|
Investigations
Increased Blood Bilirubin
|
33.3%
4/12 • 100 days post-treatment
|
|
Investigations
Increased Wbc
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Infusion Related Reaction
|
8.3%
1/12 • 100 days post-treatment
|
|
Investigations
INR Increased
|
16.7%
2/12 • 100 days post-treatment
|
|
General disorders
Intermittent Non Cardiac Chest Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Left Hip Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
8.3%
1/12 • 100 days post-treatment
|
|
Investigations
Low Tsh
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Mucositis Oral
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
8.3%
1/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • 100 days post-treatment
|
|
General disorders
Night Sweats
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Nose Bleed
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Odynophagia
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Oral Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Pain
|
16.7%
2/12 • 100 days post-treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.3%
1/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
General disorders
Post Operation Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • 100 days post-treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
8.3%
1/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
2/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
33.3%
4/12 • 100 days post-treatment
|
|
Skin and subcutaneous tissue disorders
Rash-Morbiliform
|
33.3%
4/12 • 100 days post-treatment
|
|
General disorders
Rectal Bleeding
|
8.3%
1/12 • 100 days post-treatment
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • 100 days post-treatment
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • 100 days post-treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • 100 days post-treatment
|
|
Musculoskeletal and connective tissue disorders
Upper Back Pain
|
8.3%
1/12 • 100 days post-treatment
|
|
Infections and infestations
Upper Respiratory Infection
|
8.3%
1/12 • 100 days post-treatment
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.3%
1/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • 100 days post-treatment
|
|
Gastrointestinal disorders
Vomiting After Stent
|
8.3%
1/12 • 100 days post-treatment
|
|
Investigations
Weight Loss
|
25.0%
3/12 • 100 days post-treatment
|
|
Investigations
Alt Increased
|
25.0%
3/12 • 100 days post-treatment
|
|
Investigations
Ast Increased
|
25.0%
3/12 • 100 days post-treatment
|
|
Investigations
Increased Alk Phos
|
16.7%
2/12 • 100 days post-treatment
|
Additional Information
Jennifer Wu, MD
NYU Langone Health - Perlmutter Cancer Center
Phone: 212-263-3809
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place