NCT03886493

Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Terminated Phase 2 Results posted Last updated 15 October 2021

What this trial tests

Phase 2 trial testing Dupilumab in Prostate Cancer in 7 participants. Terminated before completion.

Timeline

28 August 2019

Primary endpoint
6 October 2020

6 October 2020

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	28 August 2019
Primary completion	6 October 2020
Estimated completion	6 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Dupilumab (DUPILUMAB) — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, male only, with Prostate 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.

Safety as Assessed by Number of Participants Experiencing Adverse Events Secondary · up to 59 days post-intervention

Adverse events defined by NCI Common Toxicity Criteria version 4.0 (NCI CTCAE v4.0)

Group	Value	95% CI
Dupixent Subcutaneous (SQ) Injection	7

Feasibility as Assessed by Number of Participants Who Have an Average Blood Loss in Excess of 2500 mL During Prostatectomy Secondary · up to 59 days post-intervention

Group	Value	95% CI
Dupixent Subcutaneous (SQ) Injection	0

Feasibility as Assessed by Number of Participants With Average Prostatectomy Operative Time in Excess of 3.5 Hours Secondary · up to 59 days post-intervention

Group	Value	95% CI
Dupixent Subcutaneous (SQ) Injection	2

Feasibility as Assessed by Number of Participants With Average Hospital Stay in Excess of 4 Days Post-prostatectomy Secondary · up to 59 days post-intervention

Group	Value	95% CI
Dupixent Subcutaneous (SQ) Injection	0

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dupixent Subcutaneous (SQ) Injection

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (24 terms — click to expand)

Reaction	System	Dupixent Subcutaneous (SQ)…
Urinary incontinence	Renal and urinary disorders	—
Headache, intermittent	General disorders	—
Fatigue	General disorders	—
hyperkalemia	Metabolism and nutrition disorders	—
maculo papular rash on abdomen	Skin and subcutaneous tissue disorders	—
Bloating	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
edema in right calf and ankle	Blood and lymphatic system disorders	—
elevated hemoglobin	Blood and lymphatic system disorders	—
eye pain	Eye disorders	—
Vivid dreams	General disorders	—
hypocalcemia	Metabolism and nutrition disorders	—
hypoglycemia	Metabolism and nutrition disorders	—
Increased creatinine	Renal and urinary disorders	—
induration at injection site on abdomen	Skin and subcutaneous tissue disorders	—
laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	—
loss of appetite	Metabolism and nutrition disorders	—
nausea	Gastrointestinal disorders	—
pruritis at site of injection on abdomen	Skin and subcutaneous tissue disorders	—
reproductive system disorder, other blood in ejaculate	Reproductive system and breast disorders	—
Right AC bruising related to blood draw	Skin and subcutaneous tissue disorders	—
Skin ulceration upper lip	Skin and subcutaneous tissue disorders	—
toothache	Gastrointestinal disorders	—
urinary retention	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT03886493 adverse events section.

Sponsor's own description

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.