Trial Outcomes & Findings for BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT00828009)
NCT ID: NCT00828009
Last Updated: 2023-07-07
Results Overview
The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
70 participants
Primary outcome timeframe
Assessed every 3 weeks while on treatment and up to 5 years
Results posted on
2023-07-07
Participant Flow
E6508 was activated on December 22, 2010, accrued its first patient on January 17, 2011, suspended per protocol on January 12, 2012 for interim toxicity analysis. The study was then reactivated on October 9, 2012 to stage 2 accrual and closed to accrual on October 13, 2014.
Participant milestones
| Measure |
Tecemotide/Bevacizumab After Chemoradiation
Concomitant Chemoradiotherapy: Patients (pts) receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes weekly for 6 weeks. Pts also receive radiotherapy 5 days a week for 6½ weeks. Pts with CR, PR, or SD proceed to consolidation chemotherapy.
Consolidation chemotherapy: Pts receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression (PD) or unacceptable toxicity. Pts with CR, PR, or SD proceed to maintenance therapy.
Maintenance therapy: Pts receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and tecemotide. Pts then receive bevacizumab IV over 30-90 minutes on day 1 and tecemotide subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of PD or unacceptable toxicity.
|
|---|---|
|
Step 1 - Chemo RT/Consolidation Chemo
STARTED
|
70
|
|
Step 1 - Chemo RT/Consolidation Chemo
Started Treatment
|
68
|
|
Step 1 - Chemo RT/Consolidation Chemo
COMPLETED
|
39
|
|
Step 1 - Chemo RT/Consolidation Chemo
NOT COMPLETED
|
31
|
|
Step 2 - Maintenance Therapy
STARTED
|
33
|
|
Step 2 - Maintenance Therapy
COMPLETED
|
0
|
|
Step 2 - Maintenance Therapy
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Tecemotide/Bevacizumab After Chemoradiation
Concomitant Chemoradiotherapy: Patients (pts) receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes weekly for 6 weeks. Pts also receive radiotherapy 5 days a week for 6½ weeks. Pts with CR, PR, or SD proceed to consolidation chemotherapy.
Consolidation chemotherapy: Pts receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression (PD) or unacceptable toxicity. Pts with CR, PR, or SD proceed to maintenance therapy.
Maintenance therapy: Pts receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and tecemotide. Pts then receive bevacizumab IV over 30-90 minutes on day 1 and tecemotide subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of PD or unacceptable toxicity.
|
|---|---|
|
Step 1 - Chemo RT/Consolidation Chemo
Adverse Event
|
10
|
|
Step 1 - Chemo RT/Consolidation Chemo
Death
|
2
|
|
Step 1 - Chemo RT/Consolidation Chemo
Withdrawal by Subject
|
3
|
|
Step 1 - Chemo RT/Consolidation Chemo
Progressive disease
|
11
|
|
Step 1 - Chemo RT/Consolidation Chemo
Complicating disease
|
1
|
|
Step 1 - Chemo RT/Consolidation Chemo
No show/Patient moved
|
2
|
|
Step 1 - Chemo RT/Consolidation Chemo
Never started therapy
|
2
|
|
Step 2 - Maintenance Therapy
Progressive disease
|
12
|
|
Step 2 - Maintenance Therapy
Adverse Event
|
13
|
|
Step 2 - Maintenance Therapy
Death
|
1
|
|
Step 2 - Maintenance Therapy
Withdrawal by Subject
|
4
|
|
Step 2 - Maintenance Therapy
Complicating disease
|
2
|
|
Step 2 - Maintenance Therapy
Other
|
1
|
Baseline Characteristics
BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Step 2 - Maintenance Therapy
n=33 Participants
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 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
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 weeks while on treatment and up to 5 yearsPopulation: All patients who received step 2 treatment
The study is to evaluate the safety of the combination of tecemotide immunotherapy with bevacizumab. The target adverse events for the combined treatment are as follows: grade 4-5 hemorrhage, esophagitis, fistula, platelet count decrease (thrombocytopenia), encephalitis infection, or hepatic failure episodes.
Outcome measures
| Measure |
Step 2 - Maintenance Therapy
n=33 Participants
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Proportion of Patients With Target Adverse Events for the Step 2 Treatment
|
0.03 proportion of participants
Interval 0.003 to 0.113
|
SECONDARY outcome
Timeframe: Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 yearsPopulation: Only eligible and treated patients are included in the analysis.
Overall survival was defined as the time from the study registration until death from any cause. Patients who were alive or lost to follow-up at the time of analysis were censored at date last known alive.
Outcome measures
| Measure |
Step 2 - Maintenance Therapy
n=32 Participants
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
42.7 months
Interval 21.7 to 63.3
|
SECONDARY outcome
Timeframe: Every 3 months for patients < 2 years from study entry, and every 6 months if patient is 2-5 years from study entry; up to 5 yearsPopulation: Only eligible and treated patients are included in this analysis.
Progression-free survival was defined as the time from study registration to disease progression or death from any cause, whichever came first. If date of death was greater than 3 months after date of last disease assessment that showed progression-free, the patient was censored at the time of last disease assessment. Patients alive and without documented progression were censored at the date last known progression-free. Progression is defined using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria (version 1.1), as at least 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, the appearance of new lesions, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Step 2 - Maintenance Therapy
n=32 Participants
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
14.9 months
Interval 11.0 to 20.9
|
Adverse Events
Step 1 - Chemoradiation and Consolidation Chemotherapy
Serious events: 39 serious events
Other events: 65 other events
Deaths: 48 deaths
Step 2 - Maintenance Therapy
Serious events: 11 serious events
Other events: 32 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Step 1 - Chemoradiation and Consolidation Chemotherapy
n=68 participants at risk
Chemoradiotherapy: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes once a week for 6 weeks. Patients also undergo concurrent definitive radiotherapy 5 days a week for 6½ weeks. Patients with complete response (CR), partial response (PR), or stable disease (SD) proceed to consolidation chemotherapy.
Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD proceed to maintenance therapy.
|
Step 2 - Maintenance Therapy
n=33 participants at risk
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Death NOS
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Fatigue
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Esophageal pain
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Immune system disorders
Anaphylaxis
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Bronchial infection
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Device related infection
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Lung infection
|
2.9%
2/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Meningitis
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Mucosal infection
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Sepsis
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
10.3%
7/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Neutrophil count decreased
|
16.2%
11/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Platelet count decreased
|
4.4%
3/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Weight loss
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
White blood cell decreased
|
20.6%
14/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
2/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
5/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Headache
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Syncope
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Flushing
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Hypertension
|
1.5%
1/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
18.2%
6/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Hypotension
|
2.9%
2/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
3.0%
1/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
Other adverse events
| Measure |
Step 1 - Chemoradiation and Consolidation Chemotherapy
n=68 participants at risk
Chemoradiotherapy: Patients receive paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 15-30 minutes once a week for 6 weeks. Patients also undergo concurrent definitive radiotherapy 5 days a week for 6½ weeks. Patients with complete response (CR), partial response (PR), or stable disease (SD) proceed to consolidation chemotherapy.
Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD proceed to maintenance therapy.
|
Step 2 - Maintenance Therapy
n=33 participants at risk
Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30 minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
57.4%
39/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
54.5%
18/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Chills
|
7.4%
5/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
12.1%
4/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Fatigue
|
73.5%
50/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
78.8%
26/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Fever
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
12.1%
4/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Injection site reaction
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
General disorders
Pain
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
41.2%
28/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
36.4%
12/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
5/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.4%
5/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue - Other
|
7.4%
5/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
20.6%
14/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
22.1%
15/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
18.2%
6/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
13.2%
9/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
22.1%
15/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
47.1%
32/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
17.6%
12/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
58.8%
40/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
30.3%
10/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
19.1%
13/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Immune system disorders
Allergic reaction
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
19.1%
13/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Lymphocyte count decreased
|
11.8%
8/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
27.3%
9/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Neutrophil count decreased
|
30.9%
21/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Platelet count decreased
|
38.2%
26/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
18.2%
6/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
Weight loss
|
23.5%
16/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
12.1%
4/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Investigations
White blood cell decreased
|
58.8%
40/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
30.3%
10/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
20.6%
14/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
27.3%
9/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.3%
7/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
7/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.2%
11/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
18.2%
6/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
12/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Dizziness
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
29.4%
20/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
24.2%
8/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Headache
|
10.3%
7/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
17.6%
12/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
21.2%
7/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
32.4%
22/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
51.5%
17/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.2%
9/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
21.2%
7/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.7%
10/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
15.2%
5/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
0.00%
0/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory thoracic mediastinal - Other
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
6.1%
2/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
18.2%
6/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Flushing
|
5.9%
4/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Hypertension
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
36.4%
12/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
|
Vascular disorders
Hypotension
|
8.8%
6/68 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
9.1%
3/33 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60