Trial Outcomes & Findings for Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer (NCT NCT02648282)

NCT ID: NCT02648282

Last Updated: 2024-09-05

Results Overview

DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: 62 months
• Results posted on: 2024-09-05

Participant Flow

Participant milestones

Measure	Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer

Baseline characteristics by cohort

Measure	Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT n=58 Participants Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	7 Participants n=5 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 62 months

Population: All patients who have received at least two doses of immunotherapy and have had their disease re-evaluated with imaging will be considered evaluable for response.

DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.

Outcome measures

Measure

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT n=54 Participants Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Distant Metastasis Free Survival (DMFS)

9.8 months Interval 6.3 to 19.4

SECONDARY outcome

Timeframe: 41 months

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.

Outcome measures

Measure

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT n=58 Participants Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).

Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities

11 Participants

Adverse Events

Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT

Serious events: 6 serious events

Other events: 54 other events

Deaths: 44 deaths

Serious adverse events

Measure	Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT n=58 participants at risk Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).
Endocrine disorders Glucose intolerance	1.7% 1/58 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Abdominal pain	1.7% 1/58 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Colitis	1.7% 1/58 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Vomiting	1.7% 1/58 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Metabolism and nutrition disorders Dehydration	1.7% 1/58 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.7% 1/58 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.

Other adverse events

Measure	Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT n=58 participants at risk Cyclophosphamide: 200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg/m2 as a 30 minute IV infusion one day prior to GVAX Pancreas Vaccine every 6 months for an additional 4 doses. GVAX Pancreas Vaccine: 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of 8 doses. In the extended treatment phase, eligible patients may receive 2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells administered one day after CY every 6 months for an additional 4 doses. Pembrolizumab: 200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine every 21 days for a total of 8 doses. In the extended treatment phase, eligible patients may receive 200 mg as a 30 minute IV infusion every 21 days for an additional 9 doses. SBRT: Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX Pancreas Vaccine).
Endocrine disorders Hypothyroidism	8.6% 5/58 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Nausea	13.8% 8/58 • Number of events 9 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Stomach pain	8.6% 5/58 • Number of events 7 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Gastrointestinal disorders Vomiting	5.2% 3/58 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
General disorders Chills	5.2% 3/58 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
General disorders Fever	5.2% 3/58 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
General disorders Flu like symptoms	5.2% 3/58 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
General disorders Malaise	6.9% 4/58 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	6.9% 4/58 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Pruritus	13.8% 8/58 • Number of events 8 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Rash	13.8% 8/58 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Discoloration	6.9% 4/58 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Induration	93.1% 54/58 • Number of events 173 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Itching	86.2% 50/58 • Number of events 142 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Redness	89.7% 52/58 • Number of events 178 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Swelling	17.2% 10/58 • Number of events 18 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.
Skin and subcutaneous tissue disorders Tenderness	67.2% 39/58 • Number of events 105 • Serious and Other (Not Including Serious) Adverse Events were evaluated over 41 months. All-cause mortality was evaluated for up to 64 months. Adverse reporting collection was conducted by regular investigator assessment and laboratory measurements using NCI CTCAE v4.03. During the survival follow-up portion of the trial, participants were evaluated for all-cause mortality past the time frame of treatment and the assessment of adverse events.

Additional Information

Lei Zheng MD, PhD

Sidney Kimmel Cancer Center at Johns Hopkins

Phone: 410-502-6241

Email: lzheng6@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place