Trial Outcomes & Findings for A SU2C Catalyst® Trial of a PD1 Inhibitor With or Without a Vitamin D Analog for the Maintenance of Pancreatic Cancer (NCT NCT03331562)

Last Updated: 2022-12-27

Results Overview

Progression Free Survival (PFS) defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) survival in the absence of death or progressive disease which is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

6 months from trial treatment initiation cycle 1/day 1. Each treatment cycle is 21 days.

Results posted on

2022-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab & Paricalcitol pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Overall Study STARTED	12	12
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab & Paricalcitol pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Overall Study Adverse Event	2	0
Overall Study Death	1	0

Baseline Characteristics

A SU2C Catalyst® Trial of a PD1 Inhibitor With or Without a Vitamin D Analog for the Maintenance of Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab & Paricalcitol n=12 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection	Total n=24 Participants Total of all reporting groups
Age, Continuous	63.8 years n=5 Participants	69.3 years n=7 Participants	67.6 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 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
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
ECOG Performance Status ECOG 0	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
ECOG Performance Status ECOG 1	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months from trial treatment initiation cycle 1/day 1. Each treatment cycle is 21 days.

Population: All patients that receive trial treatment will be included in the analysis. Excludes 3 participants in the pembrolizumab + paricalcitol group: 1 participant that died due to other cause before 6 months, 2 participants who withdrew from study treatment before 6 months.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Paricalcitol n=9 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Progression- Free Survival at 6 Months From Initiation of Trial Treatment	0 Participants	2 Participants

SECONDARY outcome

Timeframe: initiation of trial treatment cycle 1/day 1 through 30 days after last dose of trial treatment. Each treatment cycle is 21 days.

Population: All patients who received any amount of trial treatment were included in the analysis. The reported AEs are those noted as possibly or definitely related to study agents.

All adverse events occurring on or after Cycle 1/day 1through 30 days after the last dose of trial treatment will be summarized by body systems and per grade according to NCI-CTCAE Version 4.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Paricalcitol n=12 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Abdominal bloating	1 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Abdominal pain	1 Participants	2 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. ALT increase	2 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Alkaline phosphatase increase	1 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Anemia	0 Participants	1 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Arthralgia	2 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. AST increase	2 Participants	1 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Creatinine increase	2 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Hypertension	0 Participants	2 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Hypophysitis	1 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Nausea	1 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Pruritis	1 Participants	0 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Uticaria	0 Participants	1 Participants
Incidence of Treatment-related Toxicities as Assessed by CTCAE v4.0 From cycle1/Day 1 Through 30 Days After the Last Dose of Trial Treatment. Vomiting	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of treatment initiation cycle 1/day 1 until death from any cause, assessed up to 24 months ( the end of the study).

Duration of survival will be defined as the time from initial treatment (cycle1/day1) until death. Overall survival will be estimated for each arm using a Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Paricalcitol n=12 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Difference in Overall Survival (OS) in Patients Administered the Combination of Paricalcitol Plus Pembrolizumab Versus Pembrolizumab Alone	10.4 months Interval 2.9 to The upper bound of the confidence interval cannot be calculated because the upper bound did not fall below 50% by the end of the study.	NA months Interval 2.5 to Median OS not be calculated for the pembrolizumab \& placebo group because the median has not yet been reached (only 4 deaths of 12 participants). The upper bound of the confidence interval cannot be calculated because the upper bound did not fall below 50% by the end of the study.

SECONDARY outcome

Timeframe: Optional tumor biopsy taken at baseline and at 9 +/- 1 week following initiation of treatment

Population: Data could not be analyzed due to lack of funding for the project.

Mutational landscapes, transcriptional programs in tumor tissue

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline, at 9 +/- 1 week following initiation of treatment, at the time of confirmed response, and at the time of trial treatment discontinuation for any reason, up to 24 months ( 35 treatment cycles).

Population: Due to lack of funding, this analysis could not be performed.

Identify cellular VDR targets in the immune microenvironment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: tumor assessments performed every 9 +/- 1 week while on treatment, up to 24 months.

Population: This planned analysis was not performed, as we were not able to obtain confirmation of disease progression by iRECIST for a majority of the patients.

Difference in disease progression according to RECIST 1.1 and iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline, patients will complete the PPCB App weekly during trial treatment, and at the time of trial treatment discontinuation for any reason, assessed up to 24 months (35 treatment cycles).Each treatment cycle is 21 days.

Population: All patients were included in the analysis.

Patient compliance rate of completing the PPCB application was calculated by the total percentage of completed questionnaires over expected questionnaires across all participants.

Outcome measures

Outcome measures
Measure	Pembrolizumab & Paricalcitol n=12 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Exploratory: Utility of a Patient Personalized Clinical Benefit (PPCB) Phone Based Application	89.4 % of questionnaires completed	92.8 % of questionnaires completed

OTHER_PRE_SPECIFIED outcome

Improvement in symptoms as recorded by the Patient Personalized Clinical Benefit (PPCB)

Outcome measures

Outcome measures
Measure	Pembrolizumab & Paricalcitol n=12 Participants pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 Participants pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Exploratory:Improvement in Symptoms as Recorded by the Patient Personalized Clinical Benefit (PPCB) With Progression at 6 Months by RECIST 1.1 Improvement in symptoms	8 Participants	7 Participants
Exploratory:Improvement in Symptoms as Recorded by the Patient Personalized Clinical Benefit (PPCB) With Progression at 6 Months by RECIST 1.1 Worsening in symptoms	4 Participants	3 Participants
Exploratory:Improvement in Symptoms as Recorded by the Patient Personalized Clinical Benefit (PPCB) With Progression at 6 Months by RECIST 1.1 No change in symptoms	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: tumor assessments performed every 9 +/- 1 week while on treatment, up to 24 months.

Population: Due to lack of funding analysis could be be completed.

Differences in tumor and/or tissue texture on CT scans between the two treatment arms

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Fecal swab samples collected pre and post dose day 1 of each cycle, up to 35 treatment cycles. Each treatment cycle is 21 days.

Population: Due to lack of funding analysis could be be completed.

Differences in gut microbial communities within and between fecal samples using alpha and beta diversity metrics based on 16S rRNA sequencing

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab & Paricalcitol

Serious events: 4 serious events

Other events: 12 other events

Deaths: 8 deaths

Pembrolizumab & Placebo

Serious events: 4 serious events

Other events: 12 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab & Paricalcitol n=12 participants at risk pembrolizumab 200 mg IV q 3 weeks and paricalcitol 25 mcg IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion paricalcitol: Paricalcitol solution for injection	Pembrolizumab & Placebo n=12 participants at risk pembrolizumab 200 mg IV q 3 weeks \& placebo- normal saline IV 3 xs per week Pembrolizumab: pembrolizumab solution for infusion placebo: normal saline solution for injection
Investigations Blood bilirubin increased	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Renal and urinary disorders Renal and urinary disorders - Other, hepatorenal syndrome	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Cardiac disorders Myocardial infarction	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Cardiac disorders Cardiac disorders - Other, takotsubo cardiomyopathy	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Gastrointestinal disorders Obstruction gastric	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Infections and infestations Sepsis	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Infections and infestations Abdominal infection	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Investigations Lipase increased	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasms- Squamous Cell Carcinoma	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	16.7% 2/12 • Number of events 2 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Nervous system disorders Stroke	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Psychiatric disorders Confusion	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 1/12 • Number of events 1 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.	0.00% 0/12 • Adverse events were collected from the time of treatment allocation/randomization through 30 days following cessation of study treatment. Participants with multiple events for a given AE term were counted only once for each AE term. If the same AE term was reported more than once for a participant, only the AE term with the highest grade was included.

Other adverse events

Additional Information

Derek Cridebring, PhD. Director, Molecular Medicine Division

Translational Genomics Research Institute (TGen) An Affiliate of City of Hope

Phone: 6023438629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60