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NCT03519308

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

Terminated EARLY_PHASE1 Results posted Last updated 15 March 2024
What this trial tests

EARLY_PHASE1 trial testing Nivolumab in Pancreatic Cancer in 3 participants. Terminated before completion.

Timeline
29 July 2020
Primary endpoint
18 April 2022
18 April 2022

Quick facts

Lead sponsorAbramson Cancer Center at Penn Medicine
PhaseEARLY_PHASE1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date29 July 2020
Primary completion18 April 2022
Estimated completion18 April 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Adverse Events Primary · 18 months

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.

GroupValue95% CI
Arm A19± 4.2
Arm B27± 0
Objective Response Rate Secondary · 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.

GroupValue95% CI
Arm A1
Arm B1
Progression-free Survival Secondary · 1 year

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

GroupValue95% CI
Arm A2
Arm B1
Proportion of Patients Undergoing Surgery Secondary · 3 months

Proportion of patients who underwent surgical resection after receiving neoadjuvant therapy

GroupValue95% CI
Arm A2
Arm B1
Overall Survival Secondary · 1 year

Overall survival 1 year after the initiation of study therapy

GroupValue95% CI
Arm A2
Arm B1
Proportion of Margin Negative Surgical Resections Secondary · 3 months

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

GroupValue95% CI
Arm A1
Arm B1

Adverse events — posted to ClinicalTrials.gov

Time frame: 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A
Serious: 1/2 (50%)
Deaths: 0/2
Arm B
Serious: 1/1 (100%)
Deaths: 0/1

Serious adverse events (4 terms)

ReactionSystemArm AArm B
Hematoma Grade 3Blood and lymphatic system disorders
Nausea Grade 3Gastrointestinal disorders
Abdominal pain Grade 3Gastrointestinal disorders
Anorexia Grade 3Metabolism and nutrition disorders
Other adverse events (25 terms — click to expand)

ReactionSystemArm AArm B
NeutropeniaBlood and lymphatic system disorders
LeukopeniaBlood and lymphatic system disorders
AnemiaBlood and lymphatic system disorders
NeuropathyNervous system disorders
LymphopeniaBlood and lymphatic system disorders
ThrombocytopeniaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
DiarrheaGastrointestinal disorders
Rash maculopapularSkin and subcutaneous tissue disorders
Skin infectionSkin and subcutaneous tissue disorders
ThrushSkin and subcutaneous tissue disorders
SyncopeNervous system disorders
DysgeusiaMetabolism and nutrition disorders
FatigueNervous system disorders
HypocalcemiaMetabolism and nutrition disorders
HypophosphatemiaMetabolism and nutrition disorders
HypoalbuminemiaBlood and lymphatic system disorders
HypokalemiaMetabolism and nutrition disorders
Cellulitis left armInfections and infestations
PruritisSkin and subcutaneous tissue disorders
FolliculitisSkin and subcutaneous tissue disorders
Bartholin's gland cystReproductive system and breast disorders
FeverGeneral disorders
HyponatremiaMetabolism and nutrition disorders
HypertriglyceridemiaMetabolism and nutrition disorders

Most-reported serious reactions: Hematoma Grade 3, Nausea Grade 3, Abdominal pain Grade 3, Anorexia Grade 3.

Data from ClinicalTrials.gov NCT03519308 adverse events section.

Sponsor's own description

The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Challenges and Opportunities for Pancreatic Cancer Immunotherapy.
    Bear AS, Vonderheide RH, O'Hara MH. · · 2020 · cited 500× · PMID 32946773 · DOI 10.1016/j.ccell.2020.08.004
  2. Tumor microenvironment participates in metastasis of pancreatic cancer.
    Ren B, Cui M, Yang G, Wang H, et al · · 2018 · cited 442× · PMID 30060755 · DOI 10.1186/s12943-018-0858-1
  3. The Extracellular Matrix and Pancreatic Cancer: A Complex Relationship.
    Weniger M, Honselmann KC, Liss AS. · · 2018 · cited 208× · PMID 30200666 · DOI 10.3390/cancers10090316
  4. Cancer-associated fibroblasts in pancreatic ductal adenocarcinoma.
    Zhang T, Ren Y, Yang P, Wang J, et al · · 2022 · cited 142× · PMID 36284087 · DOI 10.1038/s41419-022-05351-1
  5. The PDAC Extracellular Matrix: A Review of the ECM Protein Composition, Tumor Cell Interaction, and Therapeutic Strategies.
    Perez VM, Kearney JF, Yeh JJ. · · 2021 · cited 103× · PMID 34692532 · DOI 10.3389/fonc.2021.751311
  6. Cancer-Associated Fibroblasts: Versatile Players in the Tumor Microenvironment.
    Ganguly D, Chandra R, Karalis J, Teke M, et al · · 2020 · cited 99× · PMID 32957515 · DOI 10.3390/cancers12092652
  7. Recent insights into the biology of pancreatic cancer.
    Yao W, Maitra A, Ying H. · · 2020 · cited 97× · PMID 32139179 · DOI 10.1016/j.ebiom.2020.102655
  8. The Extracellular Matrix in Pancreatic Cancer: Description of a Complex Network and Promising Therapeutic Options.
    Ferrara B, Pignatelli C, Cossutta M, Citro A, et al · · 2021 · cited 94× · PMID 34503252 · DOI 10.3390/cancers13174442

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for Pancreatic Cancer

Currently open trials in the same condition.

Other Abramson Cancer Center at Penn Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03519308.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing