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

NCT03331562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-12-27

Study results available
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Summary

Chemotherapy regimens for pancreatic cancer can now stabilize a patient's cancer and/or place some patients in remission or partial remission. The challenge now is to find options for maintenance therapies that will improve survival and allow continued benefits with minimal toxicities and inconvenience to the patients. This study will determine the effects of one possible maintenance regimen.

The study is being conducted to determine the effects that pembrolizumab with or without the addition of paricalcitol may have on pancreatic cancer. Half of the patients will be randomized to receive pembrolizumab + paricalcitol and half to receive pembrolizumab + placebo.

Conditions

Interventions

DRUG

Pembrolizumab

pembrolizumab solution for infusion

DRUG

paricalcitol

Paricalcitol solution for injection

DRUG

placebo

normal saline solution for injection

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER
  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Translational Genomics Research Institute

    lead OTHER

Principal Investigators

  • Daniel D Von Hoff, MD, FACS · Translational Genomics Research Institute (TGen) An Affiliate of City of Hope

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2020-06-29
Completion
2020-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03331562 on ClinicalTrials.gov