Trial Outcomes & Findings for BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer (NCT NCT02620865)
NCT ID: NCT02620865
Last Updated: 2023-05-15
Results Overview
Descriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for OS. The median OS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2023-05-15
Participant Flow
Participant milestones
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
n=2 Participants
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsDescriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for OS. The median OS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
n=2 Participants
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Median Overall Survival (OS)
|
0.934 years
Interval 0.934 to
Median survival (MS) is calculated by using the Kaplan-Meier (KM) curve. The MS is found by seeing where the estimated KM curve intersects with the horizontal line indicating 50% survival (HL-50). The upper 90% confidence value for the MS is found by seeing where the upper confidence band (CB) for the KM estimate intersects with HL-50. For this analysis, the upper CB is 1 for the whole time period under study; which means that it never intersects with HL-50; and thus is not available to report
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Analysis cannot be performed since data were not collected
Each biomarker and computed biomarker will be evaluated for normality and transformed (including non-parametric) if necessary to achieve normality. Summary statistics (including means, medians, and standard deviations) will be produced for each variable and subsequently associate each variable with OS using Cox regression. In addition, a threshold for each variable associating with OS will be defined using classification and regression trees. The tumor will be stained for inflammatory biomarkers. Specifically, T cells with undergo cytoplasmic staining for IFN and IL-10 and the level and ratio of these markers will be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 monthsToxicity rates will be estimated using all treated patients.
Outcome measures
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
n=2 Participants
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Incidence of Toxicity (CTCAE Version 4.0)
Anorexia
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Anxiety
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Chills
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Depression
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Diarrhea
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Dizziness
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Dry Mouth
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Fatigue
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Fever
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Gastroesophageal reflux disease
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Headache
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Myalgia
|
1 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Nausea
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Rash maculo-papular
|
2 Participants
|
|
Incidence of Toxicity (CTCAE Version 4.0)
Vomiting
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsDescriptive statistics (point and exact 90% confidence interval estimates from the resultant Kaplan-Meier curve) will be generated for PFS. The median PFS will be estimated on an intention-to-treat basis (using all registered patients), and on a response-evaluable basis (using all patients who completed all BAT infusions) using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
n=2 Participants
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Progression Free Survival (PFS)
|
0.934 Years
Interval 0.934 to
Median survival (MS) is calculated by using the Kaplan-Meier (KM) curve. The MS is found by seeing where the estimated KM curve intersects with the horizontal line indicating 50% survival (HL-50). The upper 90% confidence value for the MS is found by seeing where the upper confidence band (CB) for the KM estimate intersects with HL-50. For this analysis, the upper CB is 1 for the whole time period under study; which means that it never intersects with HL-50; and thus is not available to report
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Analysis cannot be performed since data were not collected
For the quantitative immune response variables, summary statistics (including means, medians, and standard deviations) will be produced pre- and post-BATs treatment. Subsequent analyses will compare the immune response variables (after a suitable transformation, if necessary) pre- and post-treatment using a paired t-test (or Wilcoxon sign ranked test if the data are not approximately normally distributed). To explore whether immune responses associate with clinical responses, the association between the baseline of each biomarker and clinical endpoints (such as response, or OS) will be analyze
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: Analysis cannot be performed since data were not collected
To explore whether immune responses associate with clinical responses, the association between the baseline of each biomarker and clinical endpoints (such as response, or OS) will be analyzed using logistic regression for binary endpoints and Cox regression for time to event endpoints.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Anti-CD3 x Anti-EGFR BATs)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Anti-CD3 x Anti-EGFR BATs)
n=2 participants at risk
Patients receive one of the following standard chemotherapy regimens at the discretion of the treating physician: gemcitabine hydrochloride IV over 30 minutes; gemcitabine hydrochloride IV over 30 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes; oxaliplatin IV over 2 hours, fluorouracil IV over 46 hours and leucovorin calcium IV over 2 hours; or fluorouracil IV over 46 hours, leucovorin calcium IV over 2 hours, irinotecan hydrochloride IV, and oxaliplatin IV over 2 hours. Approximately 2 weeks after standard chemotherapy completion, patients receive anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV over 5-30 minutes twice weekly for 4 weeks. Patients also receive aldesleukin SC and sargramostim SC on day -3 before the first anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells infusion and continuing twice weekly until the final infusion.
Aldesleukin: Given SC
Antibody Therapy: Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
Fluorouracil: Given IV
Gemcitabine Hydrochloride: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Correlative studies
Leucovorin Calcium: Given IV
Oxaliplatin: Given IV
Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Sargramostim: Given SC
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
General disorders
Anxiety
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
General disorders
Chills
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Dry Mouth
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
General disorders
Fever
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Nervous system disorders
Headache
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Adverse event data was collected up to 3 months after off-treatment date, up to 18 months.
The definitions do not differ.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place