Trial Outcomes & Findings for APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery (NCT NCT03087591)

Last Updated: 2024-10-10

Results Overview

Will be categorized by organ system and severity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Related treatment emergent adverse events by maximum severity. Unexpected grade 4 and all grade 5 events are considered severe adverse events. CTCAE grades 3-5 allergic reactions related to study cell infusion CTCAE grades 3 and greater autoimmune reactions other than that vitiligo CTCAE grades 3 and greater organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study product infusion

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

11 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2024-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (APN401) Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (APN401) Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Overall Study Disease progression before starting treatment, removed from study	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 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	9 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	9 participants n=5 Participants
CD3+	27.4 percentage of cells STANDARD_DEVIATION 16.4 • n=5 Participants
CD4+	24.2 percentage of cells STANDARD_DEVIATION 26.8 • n=5 Participants
CD8+	19.3 percentage of cells STANDARD_DEVIATION 23.7 • n=5 Participants
CD4+ICOS+	13.2 percentage of cells STANDARD_DEVIATION 20.0 • n=5 Participants
CD8+ICOS+	11.3 percentage of cells STANDARD_DEVIATION 14.2 • n=5 Participants
CD4+FOXP3+	12.0 percentage of cells STANDARD_DEVIATION 14.7 • n=5 Participants
CD4+CD45RO+	26.2 percentage of cells STANDARD_DEVIATION 19.2 • n=5 Participants
CD3-CD56+	4.2 percentage of cells STANDARD_DEVIATION 2.8 • n=5 Participants
CD14+	6.0 percentage of cells STANDARD_DEVIATION 6.6 • n=5 Participants
CD19+	2.6 percentage of cells STANDARD_DEVIATION 4.9 • n=5 Participants
CD56+	4.9 percentage of cells STANDARD_DEVIATION 4.2 • n=5 Participants
Neutrophil to Lymphocyte Ratio	3.32 ratio STANDARD_DEVIATION 1.20 • n=5 Participants
IFN	65.1 pg/ml STANDARD_DEVIATION 17.7 • n=5 Participants
IL-2	195.1 pg/ml STANDARD_DEVIATION 231.5 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 General disorders and administration site conditions · Unobserved	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 General disorders and administration site conditions · Grade 1	1 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 General disorders and administration site conditions · Grade 2	8 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 General disorders and administration site conditions · Grade 3	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Nervous System Disorders · Unobserved	5 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Nervous System Disorders · Grade 1	4 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Nervous System Disorders · Grade 2	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Nervous System Disorders · Grade 3	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Gastrointestinal Disorders · Unobserved	6 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Gastrointestinal Disorders · Grade 1	2 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Gastrointestinal Disorders · Grade 2	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Gastrointestinal Disorders · Grade 3	1 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Musculoskeletal and connective tissue disorders · Unobserved	7 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Musculoskeletal and connective tissue disorders · Grade 1	0 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Musculoskeletal and connective tissue disorders · Grade 2	2 Participants
Number of Adverse Events Common Terminology Criteria for Adverse Events Version 4.0 Musculoskeletal and connective tissue disorders · Grade 3	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 4 years

Will be summarized as frequency counts and percentages. RECIST criteria: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Clinical Response as Assessed by RECIST Complete Response	0 Participants
Clinical Response as Assessed by RECIST Partial Response	0 Participants
Clinical Response as Assessed by RECIST Stable Disease	3 Participants
Clinical Response as Assessed by RECIST Progressive Disease	6 Participants

SECONDARY outcome

Timeframe: Days 15 and 28

Immune response as measured by frequency of immune cells

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Frequency of Immune Cells CD4+ (day 15)	19.0 percentage of cells Standard Deviation 20.0
Frequency of Immune Cells CD3+ (day 15)	37.1 percentage of cells Standard Deviation 17.3
Frequency of Immune Cells CD3+ (day 28)	40.3 percentage of cells Standard Deviation 15.1
Frequency of Immune Cells CD4+ (day 28)	26.4 percentage of cells Standard Deviation 4.0
Frequency of Immune Cells CD8+ (day 15)	15.5 percentage of cells Standard Deviation 16.1
Frequency of Immune Cells CD8+ (day 28)	22.7 percentage of cells Standard Deviation 14.1
Frequency of Immune Cells CD14+ (day 15)	5.1 percentage of cells Standard Deviation 2.8
Frequency of Immune Cells CD14+ (day 28)	7.3 percentage of cells Standard Deviation 7.3
Frequency of Immune Cells CD19+ (day 15)	1.2 percentage of cells Standard Deviation 1.6
Frequency of Immune Cells CD19+ (day 28)	2.6 percentage of cells Standard Deviation 3.2
Frequency of Immune Cells CD45RO+ (day 15)	14.8 percentage of cells Standard Deviation 8.2
Frequency of Immune Cells CD45RO+ (day 28)	37.3 percentage of cells Standard Deviation 2.0
Frequency of Immune Cells CD56+ (day 15)	4.8 percentage of cells Standard Deviation 3.4
Frequency of Immune Cells CD56+ (day 28)	8.3 percentage of cells Standard Deviation 8.5
Frequency of Immune Cells CD4+ICOS+ (day 15)	12.8 percentage of cells Standard Deviation 19.7
Frequency of Immune Cells CD4+ICOS+ (day 28)	16.8 percentage of cells Standard Deviation 15.7
Frequency of Immune Cells CD4+CD45RO+ (day 15)	14.8 percentage of cells Standard Deviation 8.2
Frequency of Immune Cells CD4+CD45RO+ (day 28)	37.3 percentage of cells Standard Deviation 2.0
Frequency of Immune Cells CD4+FOXP3+ (day 15)	13.9 percentage of cells Standard Deviation 16.4
Frequency of Immune Cells CD4+FOXP3+ (day 28)	29.5 percentage of cells Standard Deviation 18.3
Frequency of Immune Cells CD8+ICOS+ (day 15)	12.3 percentage of cells Standard Deviation 14.5
Frequency of Immune Cells CD8+ICOS+ (day 28)	25.2 percentage of cells Standard Deviation 7.8
Frequency of Immune Cells CD3-CD56+ (day 15)	4.2 percentage of cells Standard Deviation 1.7
Frequency of Immune Cells CD3-CD56+ (day 28)	5.4 percentage of cells Standard Deviation 1.1

SECONDARY outcome

Timeframe: Days 15 and 28

Immune response as measured by interferon production

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Immune Response as Measured by Interferon Production IFN (day 15)	75.1 pg/ml Standard Deviation 17.6
Immune Response as Measured by Interferon Production IFN (day 28)	90.7 pg/ml Standard Deviation 37.8
Immune Response as Measured by Interferon Production IL-2 (day 15)	226 pg/ml Standard Deviation 51.1
Immune Response as Measured by Interferon Production IL-2 (day 28)	674.4 pg/ml Standard Deviation 978.6

SECONDARY outcome

Timeframe: Days 15 and 28

Immune response as measured by neutrophil to lymphocyte ratio

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Neutrophil to Lymphocyte Ratio Day 15	2.72 ratio Standard Deviation 1.21
Neutrophil to Lymphocyte Ratio Day 28	4.98 ratio Standard Deviation 5.81

SECONDARY outcome

Timeframe: From the initial infusion to confirmation of death, assessed up to approximately 4 years

Exploratory survival plots will be estimated using the Kaplan Meier approach and median overall survival will be estimated if enough events occur.

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Overall Survival (OS)	181 days Interval 47.0 to 707.0

SECONDARY outcome

Timeframe: From the initial infusion to confirmation of progression or death, assessed up to approximately 4 years

Exploratory survival plots will be estimated using the Kaplan Meier approach and median PFS will be estimated if enough events occur.

Outcome measures

Outcome measures
Measure	Treatment (APN401) n=9 Participants Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Progression-free Survival (PFS)	70 days Interval 47.0 to 237.0

Adverse Events

Treatment (APN401)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (APN401) n=9 participants at risk Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Gastrointestinal disorders ABDOMINAL PAIN	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders ASCITES	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders NAUSEA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders FATIGUE	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Hepatobiliary disorders HEPATIC HEMORRHAGE	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders ANOREXIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.

Other adverse events

Other adverse events
Measure	Treatment (APN401) n=9 participants at risk Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 IV over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies siRNA-transfected Peripheral Blood Mononuclear Cells APN401: Given IV
Blood and lymphatic system disorders ANEMIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders ABDOMINAL PAIN	11.1% 1/9 • Number of events 4 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders ASCITES	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders CONSTIPATION	33.3% 3/9 • Number of events 3 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders DIARRHEA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders FLATULENCE	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders NAUSEA	55.6% 5/9 • Number of events 7 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders RECTAL HEMORRHAGE	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Gastrointestinal disorders VOMITING	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders CHILLS	88.9% 8/9 • Number of events 21 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders EDEMA LIMBS	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders FATIGUE	44.4% 4/9 • Number of events 4 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders FEVER	33.3% 3/9 • Number of events 5 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders FLU LIKE SYMPTOMS	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
General disorders RIGORS	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Hepatobiliary disorders BILE DUCT STENOSIS	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations ALANINE AMINOTRANSFERASE INCREASED	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations ALKALINE PHOSPHATASE INCREASE	22.2% 2/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	22.2% 2/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations BLOOD BILIRUBIN INCREASE	22.2% 2/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations CREATININE INCREASE	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Investigations WHITE BLOOD CELL DECREASED	11.1% 1/9 • Number of events 3 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders HYPERURICEMIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders HYPOALBUMINEMIA	22.2% 2/9 • Number of events 4 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders HYPOKALEMIA	22.2% 2/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders HYPONATREMIA	22.2% 2/9 • Number of events 3 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Musculoskeletal and connective tissue disorders ARTHRALGIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Musculoskeletal and connective tissue disorders BACK SPASM	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Musculoskeletal and connective tissue disorders MYALGIA	11.1% 1/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Musculoskeletal and connective tissue disorders NECK PAIN	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Nervous system disorders DIZZINESS	22.2% 2/9 • Number of events 3 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Nervous system disorders HEADACHE	55.6% 5/9 • Number of events 14 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Nervous system disorders PARESTHESIA	22.2% 2/9 • Number of events 2 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Renal and urinary disorders CYSTITIS NONINFECTIVE	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Renal and urinary disorders DYSURIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Vascular disorders HEMATOMA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Vascular disorders HOT FLASHES	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Vascular disorders HYPERTENSION	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Vascular disorders HYPOTENSION	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.
Metabolism and nutrition disorders ANOREXIA	11.1% 1/9 • Number of events 1 • Adverse events were recorded during treatment and follow up 30 days past treatment and up to approximately 4 years for survival.

Additional Information

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Phone: 336-716-5772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place