Trial Outcomes & Findings for Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L) (NCT NCT04021108)
NCT ID: NCT04021108
Last Updated: 2026-08-21
Results Overview
This will be measured by number of patients without disease progression at 12 months in the two study arms (patients who receive nivolumab with radiation and those who receive nivolumab alone)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
12 months
Results posted on
2026-08-21
Participant Flow
Of the 80 enrolled patients, 13 were not randomized, leaving 67 randomized patients. Reasons for non-randomization included progressive disease (n=7), non-evaluable disease (n=5), and withdrawal of consent (n=1).
Participant milestones
| Measure |
Cohort 1
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)
Baseline characteristics by cohort
| Measure |
Cohort 1
n=33 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
20 Participants
n=109 Participants
|
36 Participants
n=133 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
14 Participants
n=109 Participants
|
31 Participants
n=133 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=109 Participants
|
19 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=109 Participants
|
48 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
10 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=109 Participants
|
52 Participants
n=133 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=109 Participants
|
8 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
28 Participants
n=109 Participants
|
52 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=109 Participants
|
6 Participants
n=133 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
34 Participants
n=109 Participants
|
67 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThis will be measured by number of patients without disease progression at 12 months in the two study arms (patients who receive nivolumab with radiation and those who receive nivolumab alone)
Outcome measures
| Measure |
Cohort 1
n=33 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Number of Patients With 12-month Progression Free Survival in Each Arm
|
9 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Per protocol section 11.1, this outcome measure will be reported for both randomized arms combined.
This will be measured by the number of patients without disease progression at 12 months in all enrolled patients.
Outcome measures
| Measure |
Cohort 1
n=67 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Amongst All Randomized Subjects, the Number of Subjects That Achieved 12-month Progression Free Survival
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 yearIn both study arms, we will examine the rate of survival in patients over time from registration through their treatment
Outcome measures
| Measure |
Cohort 1
n=33 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Amongst All Randomized Subjects, Overall Survival, as Measured by the Rate of Survival in Patients, at 1-year
|
72.77 percentage of patients
|
64.71 percentage of patients
|
SECONDARY outcome
Timeframe: 2 yearWe will measure the rate of grade 3 or 4 adverse events attributable to immunotherapy in both study arms
Outcome measures
| Measure |
Cohort 1
n=33 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 Participants
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Occurrence of Significant Toxicity, as Measured by Rate of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to Immunotherapy Per the Study Cohort
|
21.21 percentage of patients
|
26.47 percentage of patients
|
Adverse Events
Cohort 1
Serious events: 18 serious events
Other events: 22 other events
Deaths: 23 deaths
Cohort 2
Serious events: 18 serious events
Other events: 23 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Cohort 1
n=33 participants at risk
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 participants at risk
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Alanine aminotransferase increased
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Alkaline phosphatase increased
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Immune system disorders
Allergic Reaction
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Appetite decreased
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Ascites
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Cardiac disorders
Atrial fibrillation
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Blood bilirubin increased
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Infections and infestations
COVID-19
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Aphasia
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Esophageal obstruction
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Fatigue
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Endocrine disorders
Hypophysitis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Hepatobiliary disorders
Hepatitis
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
incarcerated hernia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Infusion related reaction
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Lymphocyte count decreased
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Mucositis oral
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Neutrophil count decreased
|
24.2%
8/33 • Number of events 12 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 6 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Chest Pain
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Infections and infestations
Sepsis
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Cardiac disorders
Sick sinus syndrome
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Stroke
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Infections and infestations
Abscess
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Syncope
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Weight Loss
|
0.00%
0/33 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
White blood cell decreased
|
6.1%
2/33 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
0.00%
0/34 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
Other adverse events
| Measure |
Cohort 1
n=33 participants at risk
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
Cohort 2
n=34 participants at risk
Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2.
Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)
Nivolumab 240 MG: Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.2%
8/33 • Number of events 17 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
8.8%
3/34 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • Number of events 28 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
47.1%
16/34 • Number of events 29 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Fatigue
|
48.5%
16/33 • Number of events 23 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
55.9%
19/34 • Number of events 29 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
11/33 • Number of events 15 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
35.3%
12/34 • Number of events 17 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Neutrophil Count Decreased
|
45.5%
15/33 • Number of events 31 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
44.1%
15/34 • Number of events 25 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Vomiting
|
42.4%
14/33 • Number of events 22 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
32.4%
11/34 • Number of events 21 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Blood and lymphatic system disorders
Anemia
|
24.2%
8/33 • Number of events 17 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
17.6%
6/34 • Number of events 16 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
9/33 • Number of events 20 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
17.6%
6/34 • Number of events 16 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.1%
4/33 • Number of events 8 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
23.5%
8/34 • Number of events 13 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Alkaline phosphatase increased
|
21.2%
7/33 • Number of events 14 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
17.6%
6/34 • Number of events 12 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Weight Loss
|
21.2%
7/33 • Number of events 15 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
17.6%
6/34 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Lymphocyte count decreased
|
21.2%
7/33 • Number of events 15 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
8.8%
3/34 • Number of events 6 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
5/33 • Number of events 12 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 8 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Platelet Count Decreased
|
15.2%
5/33 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
14.7%
5/34 • Number of events 8 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.2%
5/33 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
23.5%
8/34 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Number of events 10 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
14.7%
5/34 • Number of events 6 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Anorexia
|
15.2%
5/33 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
29.4%
10/34 • Number of events 11 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Dysesthesia
|
21.2%
7/33 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
20.6%
7/34 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
White blood cell count decreased
|
12.1%
4/33 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Dysphagia
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
14.7%
5/34 • Number of events 11 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Alanine aminotransferase increased
|
12.1%
4/33 • Number of events 11 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
6/33 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
20.6%
7/34 • Number of events 7 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Dizziness
|
33.3%
11/33 • Number of events 11 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Mucositis oral
|
21.2%
7/33 • Number of events 11 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Number of events 10 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
5.9%
2/34 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Pyrexia
|
12.1%
4/33 • Number of events 8 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
21.2%
7/33 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Hiccups
|
9.1%
3/33 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
17.6%
6/34 • Number of events 6 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Investigations
Albumin decreased
|
12.1%
4/33 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 2 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Paresthesia
|
15.2%
5/33 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
14.7%
5/34 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.1%
2/33 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
8.8%
3/34 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
3/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
14.7%
5/34 • Number of events 6 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
General disorders
Edema limb
|
6.1%
2/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
8.8%
3/34 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Abdominal Distension
|
15.2%
5/33 • Number of events 9 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Nervous system disorders
Dysgeusia
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
11.8%
4/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.1%
2/33 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.1%
2/33 • Number of events 5 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
3/33 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
8.8%
3/34 • Number of events 3 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.1%
4/33 • Number of events 4 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from treatment start to end of treatment (up to 3 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place