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Study Evaluating NEOadjuvant Immunotherapy in Resectable PANCreatic Ductal Adenocarcinoma (NEOiPANC)

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ClinicalTrials.gov Identifier: NCT03979066
Recruitment Status : Terminated (Loss of funding)
First Posted : June 7, 2019
Results First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Collaborators:
Genentech, Inc.
Halozyme Therapeutics
Information provided by (Responsible Party):
Gulam Manji, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Ductal Adenocarcinoma
Interventions Drug: Atezolizumab
Drug: PEGPH20
Enrollment 1
Recruitment Details  
Pre-assignment Details One participant was enrolled but was not randomized, as the participant was determined to be a screen failure.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Period Title: Overall Study
Started 0 0
Completed 0 0
Not Completed 0 0
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20 Total
Hide Arm/Group Description

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Total of all reporting groups
Overall Number of Baseline Participants 0 0 0
Hide Baseline Analysis Population Description
One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Age, Categorical  
Number Analyzed 0 participants 0 participants 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Age, Continuous  
Number Analyzed 0 participants 0 participants 0 participants
Sex: Female, Male  
Number Analyzed 0 participants 0 participants 0 participants
Female
Male
Race (NIH/OMB)  
Number Analyzed 0 participants 0 participants 0 participants
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or Not Reported
Region of Enrollment  
United States Number Analyzed 0 participants 0 participants 0 participants
Study-Specific Baseline Measure  
Number Analyzed 0 participants 0 participants 0 participants
1.Primary Outcome
Title Change in the Number of CD8+ T Cells Within the Tumor
Hide Description The change in number of intratumoral CD8+ T-cells the at time of surgery between treatment arm(s) compared to the atezolizumab arm. The CD8+ T-cell count within the tumor with neoadjuvant atezolizumab vs atezolizumab + PEGPH20 at the time of surgery will be reported using means and standard deviations by group and will be compared using a twosample T-test. If the data are not normally distributed, non-parametric models such as the Wilcoxon Rank Sum test will be used. Moreover, the distribution of CD8+ T-cell count by treatment arm will be assessed using box plots, histograms, and q-q plots.
Time Frame At time of surgery (approximately 3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description:

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 18-Month Survival Rate
Hide Description To estimate the 18-month survival rate in patients treated with atezolizumab vs atezolizumab + PEGPH20 followed by surgery and adjuvant therapy.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description:

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description To estimate the overall survival in patients treated with atezolizumab vs atezolizumab + PEGPH20 followed by surgery and adjuvant therapy.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description:

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title R0 Resection Rate
Hide Description To determine the R0 resection rates with atezolizumab vs atezolizumab + PEGPH20 administered in the neoadjuvant setting. R0 resection rate is defined by the proportion of patients in whom an R0 resection was achieved during surgery. R0 resection is defined by complete removal of macroscopic tumor which contains negative microscopic surgical margins. The R0 resection rate will be estimated by the number of patients in whom R0 resection was performed divided by total number of patients in each study arm. The R0 resection rate will be reported along with the exact 95% confidence interval. The investigators will compare the R0 resection rates using Fisher's exact test.
Time Frame At time of surgery (approximately 3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled in the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description:

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Incidence of Treatment-Emergent Adverse Events
Hide Description To determine the safety profile with atezolizumab vs atezolizumab + PEGPH20 or other therapies followed by surgery and adjuvant therapy. The frequency and count of grade 3 or higher adverse events will be reported by treatment group. The maximum grade for each type of adverse event will also be reported.
Time Frame Cycle 1 through 28 days after adjuvant chemotherapy period
Hide Outcome Measure Data
Hide Analysis Population Description
One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description:

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description One participant enrolled into the study. That participant was determined to be a screen failure. Data was not collected and therefore there is no data to analyze.
 
Arm/Group Title Atezolizumab Atezolizumab in Combination With PEGPH20
Hide Arm/Group Description

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Atezolizumab: 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.

PEGPH20: PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

All-Cause Mortality
Atezolizumab Atezolizumab in Combination With PEGPH20
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Atezolizumab Atezolizumab in Combination With PEGPH20
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atezolizumab Atezolizumab in Combination With PEGPH20
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gulam Manji, MD, PhD
Organization: Columbia University
Phone: 212-305-0592
EMail: gam2140@columbia.edu
Layout table for additonal information
Responsible Party: Gulam Manji, Columbia University
ClinicalTrials.gov Identifier: NCT03979066    
Other Study ID Numbers: AAAS1908
First Submitted: June 6, 2019
First Posted: June 7, 2019
Results First Submitted: December 1, 2020
Results First Posted: December 23, 2020
Last Update Posted: December 23, 2020