Trial Outcomes & Findings for A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer (NCT NCT03519308)

NCT ID: NCT03519308

Last Updated: 2024-03-15

Results Overview

An adverse event (AE) was defined as any unfavorable symptom, sign, illness or experience that occurs at any dose and develops or worsens in severity during the course of the study. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

3 participants

Primary outcome timeframe

18 months

Results posted on

2024-03-15

Participant Flow

Treatment naïve patients with apparently resectable adenocarcinoma of the pancreas with the epithelial subtype were enrolled at the University of Pennsylvania from July 2020 through April 2022.

Patients pre-treated with chemotherapy nivolumab were randomized 1:1 to receive (Arm A) or not receive (Arm B) weekly intravenous paricalcitol. 3 patients were enrolled in the study, therefore, the target enrollment of 20 patients was not reached.

Participant milestones

Participant milestones
Measure	Arm A Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Microenvironment in Resectable Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery	Total n=3 Participants Total of all reporting groups
Age, Continuous	58.5 years n=5 Participants	57 years n=7 Participants	57 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: participants

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Number of Adverse Events	19 number of adverse events Standard Deviation 4.2	27 number of adverse events Standard Deviation 0

SECONDARY outcome

Timeframe: 3 months

Objective response rate by RECIST v 1.1 after neoadjuvant chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Objective Response Rate	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Proportion of patients alive without progression 1 year from the start of study therapy

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Progression-free Survival	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients who underwent surgical resection after receiving neoadjuvant therapy

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Proportion of Patients Undergoing Surgery	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 year

Overall survival 1 year after the initiation of study therapy

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Overall Survival	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Proportion of patients undergoing surgical resection with surgical margins uninvolved by tumor

Outcome measures

Outcome measures
Measure	Arm A n=2 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 Participants Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Proportion of Margin Negative Surgical Resections	1 Participants	1 Participants

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm B

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=2 participants at risk Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 participants at risk Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Blood and lymphatic system disorders Hematoma Grade 3	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Gastrointestinal disorders Nausea Grade 3	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Gastrointestinal disorders Abdominal pain Grade 3	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Anorexia Grade 3	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Other adverse events

Additional Information

Liudmila Mazaleuskaya/Pancreas Research Program Manager

Abramson Cancer Center, University of Pennsylvania

Phone: 2674559141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A n=2 participants at risk Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery Paricalcitol: Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery	Arm B n=1 participants at risk Nivolumab: Before Surgery Wks 1 \&3, After Surgery Wks 1 \&3 Nab-Paclitaxel: Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery Gemcitabine: Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
Blood and lymphatic system disorders Neutropenia	100.0% 2/2 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Blood and lymphatic system disorders Leukopenia	100.0% 2/2 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Blood and lymphatic system disorders Lymphopenia	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Nervous system disorders Neuropathy	100.0% 2/2 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Gastrointestinal disorders Vomiting	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Skin and subcutaneous tissue disorders Rash maculopapular	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Skin and subcutaneous tissue disorders Skin infection	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Skin and subcutaneous tissue disorders Thrush	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Nervous system disorders Syncope	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Dysgeusia	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Nervous system disorders Fatigue	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	0.00% 0/1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Hypophosphatemia	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Blood and lymphatic system disorders Hypoalbuminemia	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Infections and infestations Cellulitis left arm	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Skin and subcutaneous tissue disorders Folliculitis	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Reproductive system and breast disorders Bartholin's gland cyst	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
General disorders Fever	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 3 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/2 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.	100.0% 1/1 • Number of events 1 • 18 months Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.