Trial Outcomes & Findings for Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer (NCT NCT03344172)

Last Updated: 2020-05-14

Results Overview

Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (\< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (\< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

up to 3 years

Results posted on

2020-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Overall Study STARTED	16	16
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Overall Study Received <1 dose of treatment	1	0

Baseline Characteristics

The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: up to 3 years

Population: Participants that received at least one cycle/dose of study treatment for whom tissue samples were available for histological evaluation using the Grading System for Pathological Response.

Outcome measures

Outcome measures
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=6 Participants Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=8 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Proportion of Grade IIb or Higher Histolopathologic Responses	33.3 percentage of participants Interval 4.3 to 77.7	50.0 percentage of participants Interval 18.7 to 81.3

SECONDARY outcome

Timeframe: Up to 3 years

Population: Participants that received at least one cycle/dose of study treatment for whom tissue samples were available for analysis.

Levels of CA19-9 (tumor marker) in preoperative and postoperative tissues will be determined. Higher levels of CA19-9 are associated with progressive disease.

Outcome measures

Outcome measures
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=5 Participants Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=5 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Change in CA19-9 Levels	-0.37 units per milliliter (U/mL) Interval -0.87 to 0.13	-0.88 units per milliliter (U/mL) Interval -1.54 to -0.22

SECONDARY outcome

Timeframe: Up to 6 months

Population: Participants that received at least one cycle/dose of study treatment.

Percentage of participants that experienced an adverse event at least possibly related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Outcome measures

Outcome measures
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=15 Participants Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=16 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment Grade 1	6.7 percetage of participants Interval 0.5 to 49.6	6.3 percetage of participants Interval 0.5 to 47.8
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment Grade 2	40.0 percetage of participants Interval 12.0 to 76.4	18.8 percetage of participants Interval 3.5 to 59.6
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment Grade 3	40.0 percetage of participants Interval 12.0 to 76.4	62.5 percetage of participants Interval 26.0 to 88.8
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment Grade 4	6.7 percetage of participants Interval 5.1 to 49.6	0.0 percetage of participants Interval 0.0 to 40.9
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment Grade 5	6.7 percetage of participants Interval 5.1 to 49.6	6.3 percetage of participants Interval 0.5 to 47.8
Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment No Adverse Events	0.0 percetage of participants Interval 0.0 to 52.5	6.3 percetage of participants Interval 0.5 to 47.8

SECONDARY outcome

Timeframe: Up to 6 months

Population: Participants that received at least one cycle/dose of study treatment.

Percentage of participants that experienced an adverse event at least probably related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

Outcome measures

Outcome measures
Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=15 Participants Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=16 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment Grade 1	13.3 percentage of participants Interval 1.8 to 56.0	12.5 percentage of participants Interval 1.7 to 54.0
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment Grade 2	33.3 percentage of participants Interval 8.9 to 71.9	18.8 percentage of participants Interval 3.5 to 59.6
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment Grade 3	33.3 percentage of participants Interval 8.9 to 71.9	43.3 percentage of participants Interval 14.5 to 78.1
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment Grade 4	0.0 percentage of participants Interval 0.0 to 42.4	0.0 percentage of participants Interval 0.0 to 40.9
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment Grade 5	0.0 percentage of participants Interval 0.0 to 42.4	0.0 percentage of participants Interval 0.0 to 40.9
Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment No Adverse Events	20.0 percentage of participants Interval 3.7 to 61.8	25.0 percentage of participants Interval 0.6 to 64.7

SECONDARY outcome

Timeframe: Up to 3 years

Population: Collected specimens will not be run/analyzed due to lack of funding.

Autophagy biomarker levels in blood by histopathological response (per the Grading System for Pathological Response)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

Population: Collected specimens will not be run/analyzed due to lack of funding.

Comparison of the preoperative and postoperative Thromboelastogram (TEG) Coagulation Index (CI) profile. TEG is an overall assessment of coagulability, quantitatively measures the ability of whole blood to form a clot. Cancer patients are at greater risk for thromboembolism compared to the normal population due to tumor burden and systemic therapies.

Outcome measures

Outcome data not reported

Adverse Events

PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab

Serious events: 9 serious events

Other events: 15 other events

Deaths: 1 deaths

PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine

Serious events: 12 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Barbara Stadterman, MPH, MCCR; CRS Regulatory Supervisor

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=15 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=16 Participants Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery	Total n=31 Participants Total of all reporting groups
Race (NIH/OMB) Safety cohort · White	15 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	16 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	31 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · More than one race	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Age, Continuous Safety cohort	64.4 years STANDARD_DEVIATION 6.5 • n=15 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	69.9 years STANDARD_DEVIATION 9.8 • n=16 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	67.0 years STANDARD_DEVIATION 8.7 • n=31 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Age, Continuous Efficacy cohort	62.2 years STANDARD_DEVIATION 6.4 • n=8 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	65.6 years STANDARD_DEVIATION 9.7 • n=10 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	64.1 years STANDARD_DEVIATION 8.3 • n=18 Participants • The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Sex: Female, Male Safety cohort · Female	6 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	7 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	13 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Sex: Female, Male Safety cohort · Male	9 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	9 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	18 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Sex: Female, Male Efficacy cohort · Female	3 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	5 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	8 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Sex: Female, Male Efficacy cohort · Male	5 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	5 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	10 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · American Indian or Alaska Native	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · Asian	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · Black or African American	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Safety cohort · Unknown or Not Reported	0 Participants n=15 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=16 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=31 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · American Indian or Alaska Native	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · Asian	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · Black or African American	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · White	8 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	10 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	18 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · More than one race	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Race (NIH/OMB) Efficacy cohort · Unknown or Not Reported	0 Participants n=8 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=10 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	0 Participants n=18 Participants • The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Karnofsky Performance Status - Safety Cohort Safety Cohort - Karnofsky Score of 90	6 Participants n=14 Participants • The Safety Cohort includes the 31 participants who received at least one dose.	3 Participants n=16 Participants • The Safety Cohort includes the 31 participants who received at least one dose.	9 Participants n=30 Participants • The Safety Cohort includes the 31 participants who received at least one dose.
Karnofsky Performance Status - Safety Cohort Safety Cohort - Karnofsky Score of 100	8 Participants n=14 Participants • The Safety Cohort includes the 31 participants who received at least one dose.	13 Participants n=16 Participants • The Safety Cohort includes the 31 participants who received at least one dose.	21 Participants n=30 Participants • The Safety Cohort includes the 31 participants who received at least one dose.
Karnofsky Performance Status - Efficacy Cohort Efficacy Cohort - Karnofsky Score of 90	4 Participants n=7 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	1 Participants n=10 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	5 Participants n=17 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Karnofsky Performance Status - Efficacy Cohort Efficacy Cohort - Karnofsky Score of 100	3 Participants n=7 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	9 Participants n=10 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.	12 Participants n=17 Participants • The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.

Measure	PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab n=15 participants at risk Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery	PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine n=16 participants at risk Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m\^2) and nab-paclitaxel (125mg/m\^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
Blood and lymphatic system disorders Anemia	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Blood and lymphatic system disorders Febrile neutropenia	6.7% 1/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Cardiac disorders Cardiac arrest	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
General disorders Fatigue	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
General disorders Fever	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Infections and infestations Biliary tract infection	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Infections and infestations Salivary gland infection	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Injury, poisoning and procedural complications Fall	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Investigations Alanine aminotransferase increased	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Investigations Lymphocyte count decreased	13.3% 2/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Investigations Neutrophil count decreased	20.0% 3/15 • Number of events 12 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	25.0% 4/16 • Number of events 18 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Investigations White blood cell decreased	13.3% 2/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Metabolism and nutrition disorders Anorexia	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	12.5% 2/16 • Number of events 7 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	18.8% 3/16 • Number of events 9 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Skin and subcutaneous tissue disorders Rash maculo-papular	13.3% 2/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	12.5% 2/16 • Number of events 6 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	13.3% 2/15 • Number of events 8 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Vascular disorders Hypertension	0.00% 0/15 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Vascular disorders Hypotension	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	6.2% 1/16 • Number of events 3 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.
Vascular disorders Thromboembolic event	6.7% 1/15 • Number of events 4 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.	0.00% 0/16 • Up to 6 months per participant; 18 months for each cohort All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. Serious Adverse Events included only events of Grade 3 or greater.