Trial Outcomes & Findings for Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases (NCT NCT01505166)
NCT ID: NCT01505166
Last Updated: 2021-11-01
Results Overview
To evaluate and correlate Tumor Infiltrating Lymphocytes (TIL) in initial excised tumor and Enzyme-Linked ImmunoSorbent Spot (ELISPOT) responses to Vigil™ vaccine in blood of patients with CLM.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2021-11-01
Participant Flow
This study recruited patients with colorectal carcinoma with liver metastases following resection and had successful manufacturing of Vigil (minimum of 4 doses). Part 1 would enroll the first 6 patients (Vigil plus chemotherapy) and then Part 2 would randomize subsequent patients (Vigil plus chemotherapy or Placebo plus chemotherapy).
3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. No other subjects were enrolled in Part 1 and also Part 2.
Participant milestones
| Measure |
Vigil™ Vaccine (Part 1) - 6 Patient run-in
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Vigil™ (Part 2)
Patients will receive 1 x 10\^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo (Part 2)
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Phase II Adjuvant Chemotherapy ± FANG™ in Colorectal Carcinoma With Liver Metastases
Baseline characteristics by cohort
| Measure |
Vigil™ Vaccine (Part 1) 6 Patient run-in
n=3 Participants
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Vigil™ (Part 2)
Patients will receive 1 x 10\^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo (Part 2)
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
0-15 Years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Customized
16-64 Years
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Age, Customized
65 Years and Older
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. However, TIL was not tested/collected so no correlation could be performed. Statistical analysis was not done. This study was terminated.
To evaluate and correlate Tumor Infiltrating Lymphocytes (TIL) in initial excised tumor and Enzyme-Linked ImmunoSorbent Spot (ELISPOT) responses to Vigil™ vaccine in blood of patients with CLM.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.
Response rate will also be evaluated in this study using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.The response in patients with measurable disease will be reported using standard outcome measures for clinical trials: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Any response to treatment (either PR or CR) requires two confirmatory staging at least 4 weeks apart. Patients will be evaluable for tumor response if measurable disease is present.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.
To determine and compare the overall survival rate in patients with CLM following resection +/- ablation with curative intent treated with sandwich or adjuvant chemotherapy and Vigil™ vaccine versus sandwich or adjuvant chemotherapy and placebo and compare with historical data.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Treatment (30 days after last dose) up to 12 monthsPopulation: 3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 12 months, all 3 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.
To determine if subjects will have a positive (defined as \>10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.
Outcome measures
| Measure |
Vigil™ Vaccine (Part 1) - 6 Patient run-in
n=3 Participants
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo (Part 2)
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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|---|---|---|
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Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)
ELISPOT-Positive After 12 months
|
3 Participants
|
—
|
|
Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)
ELISPOT-Negative After 12 months
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 MonthsPopulation: 3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 24 months, 2 subjects were still alive and 1 subject was dead. Statistical analysis was not done. This study was terminated.
For Part 1, this was to determine the overall survival rate in patients with CLM following resection +/= ablation with curative intent treated with adjuvant chemotherapy and Vigil™ by following these patients up to 24 months.
Outcome measures
| Measure |
Vigil™ Vaccine (Part 1) - 6 Patient run-in
n=3 Participants
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo (Part 2)
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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|---|---|---|
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Number of Alive Subjects (Part 1)
Alive after 24 months
|
2 Participants
|
—
|
|
Number of Alive Subjects (Part 1)
Dead after 24 months
|
1 Participants
|
—
|
Adverse Events
Vigil™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vigil™ Vaccine (6 Patient run-in)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vigil™
Patients will receive 1 x 10\^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Vigil™ Vaccine (6 Patient run-in)
n=3 participants at risk
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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|---|---|---|---|
|
Vascular disorders
Thromboembolic Event
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
33.3%
1/3 • Number of events 1
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
|
Infections and infestations
Urinary Tract Infection
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
33.3%
1/3 • Number of events 1
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
33.3%
1/3 • Number of events 1
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
Other adverse events
| Measure |
Vigil™
Patients will receive 1 x 10\^7 cells (Group A) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses (vaccine) starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Placebo
Patients will receive placebo (Group B) via intradermal injection for a minimum of 4 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days.
Placebo: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
|
Vigil™ Vaccine (6 Patient run-in)
n=3 participants at risk
Six patients will be enrolled into the Part 1 of the study to receive intradermal autologous Vigil™ cancer vaccine (1.0 x 10e7 cells/injection; maximum of 12 vaccinations).
Vigil™ Vaccine: Patients will receive 1 x 10\^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
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|---|---|---|---|
|
General disorders
Injection Site Reaction
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
—
0/0
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
100.0%
3/3 • Number of events 3
At the time that the trial closed, only one subject had died. The other two were still alive. Three serious adverse events were reported during the same hospitalization for one subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place