Trial · NCT02620865

BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer

NCT02620865, Phase 1, Phase 2, Completed, Barbara Ann Karmanos Cancer Institute; results first posted 2023-05-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer. Trials, record NCT02620865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02620865

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer
NCT number: NCT02620865
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Conditions: Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Carcinoma, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
Interventions: Aldesleukin, Antibody Therapy, Fluorouracil, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Leucovorin Calcium, Oxaliplatin, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Sargramostim
First posted: 2015-12-03
Last updated: 2023-05-15
Results first posted: 2023-05-15

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Median Overall Survival (OS)	Up to 18 months	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.
Secondary	Biomarker Analysis (Including CD3, CD4, CD8, PD1, PDL1, Monocytes, MDSC, IFN-gamma, IL-10, and TILs) Assessed Using Immunohistochemistry	Up to 18 months	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.
Secondary	Incidence of Toxicity (CTCAE Version 4.0)	Up to 18 months	Toxicity rates will be estimated using all treated patients.
Secondary	Progression Free Survival (PFS)	Up to 18 months	Descriptive 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.
Secondary	Quantitative Immune Response	Up to 18 months	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
Secondary	TTP	Up to 18 months	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Overall Survival (OS)	Up to 18 months		years	MEDIAN
SECONDARY	Biomarker Analysis (Including CD3, CD4, CD8, PD1, PDL1, Monocytes, MDSC, IFN-gamma, IL-10, and TILs) Assessed Using Immunohistochemistry	Up to 18 months	Analysis cannot be performed since data were not collected
SECONDARY	Incidence of Toxicity (CTCAE Version 4.0)	Up to 18 months		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival (PFS)	Up to 18 months		Years	MEDIAN
SECONDARY	Quantitative Immune Response	Up to 18 months	Analysis cannot be performed since data were not collected
SECONDARY	TTP	Up to 18 months	Analysis cannot be performed since data were not collected

Source ClinicalTrials.gov

Results by group17

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Median Overall Survival (OS)	Treatment (Anti-CD3 x Anti-EGFR BATs)		0.934	90% Confidence Interval 0.934 to NA	years
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Anorexia	1		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Anxiety	1		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Chills	2		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Depression	1		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Diarrhea	2		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Dizziness	1		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Dry Mouth	1		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Fatigue	2		Participants
Incidence of Toxicity (CTCAE Version 4.0)	Treatment (Anti-CD3 x Anti-EGFR BATs)	Fever	2		Participants

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Anti-CD3 x Anti-EGFR BATs)	2
Overall Study	COMPLETED	Treatment (Anti-CD3 x Anti-EGFR BATs)	2
Overall Study	NOT COMPLETED	Treatment (Anti-CD3 x Anti-EGFR BATs)	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anorexia	Gastrointestinal disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
other	Anxiety	General disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
other	Chills	General disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	2	2
other	Depression	Psychiatric disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
other	Diarrhea	Gastrointestinal disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	2	2
other	Dizziness	Nervous system disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
other	Dry Mouth	Gastrointestinal disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
other	Fatigue	General disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	2	2
other	Fever	General disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	2	2
other	Gastroesophageal reflux disease	Gastrointestinal disorders	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Anti-CD3 x Anti-EGFR BATs)	1	2
Total, other adverse events	Treatment (Anti-CD3 x Anti-EGFR BATs)	2	2
Total, serious adverse events	Treatment (Anti-CD3 x Anti-EGFR BATs)	0	2

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32939319	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA022453	CANCER CENTER SUPPORT GRANT	PASCHE, BORIS	WAYNE STATE UNIVERSITY	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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