Trial Outcomes & Findings for Study Evaluating NEOadjuvant Immunotherapy in Resectable PANCreatic Ductal Adenocarcinoma (NCT NCT03979066)
NCT ID: NCT03979066
Last Updated: 2020-12-23
Results Overview
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.
TERMINATED
PHASE2
1 participants
At time of surgery (approximately 3 weeks)
2020-12-23
Participant Flow
One participant was enrolled but was not randomized, as the participant was determined to be a screen failure.
Participant milestones
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Atezolizumab
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.
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Atezolizumab in Combination With PEGPH20
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.
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Overall Study
STARTED
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating NEOadjuvant Immunotherapy in Resectable PANCreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At time of surgery (approximately 3 weeks)Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 MonthsPopulation: 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.
To estimate the 18-month survival rate in patients treated with atezolizumab vs atezolizumab + PEGPH20 followed by surgery and adjuvant therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: 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.
To estimate the overall survival in patients treated with atezolizumab vs atezolizumab + PEGPH20 followed by surgery and adjuvant therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of surgery (approximately 3 weeks)Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 through 28 days after adjuvant chemotherapy periodPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab
Atezolizumab in Combination With PEGPH20
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place