Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.

dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.

Dupilumab

Kenneth Pienta, MD

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.

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 in men with high-risk localized prostate cancer (this trial will enroll men with at least high risk prostate cancer defined by NCCN Guidelines Version 2.2017 = clinical stage ≥T3a or PSA \>20 ng/mL or Gleason score ≥8).

Patients will be recruited from the outpatient Urology clinic. Men will be treated with dupilumab 600 mg subcutaneously (SQ) on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.

Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

Men will be treated with dupilumab 600 mg s.q. on day 1, and then 300 mg s.q. on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. Fourteen days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

Subjects must have a prostate in order to be eligible for this trial.

Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Change in M2-TAM infiltration (number of macrophages / cell nuclei per high power field \[hpf\]) measured in pre- dupilumab biopsy to M2-TAM infiltration measured in post-dupilumab specimen collected at time of radical prostatectomy (up to 59 days post-intervention). Degree of TAM infiltration will be analyzed using immunohistochemical staining for CD206. It is hypothesized that a positive value will be associated with better outcome and a negative value will reflect a worse outcome.

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

mean CD4+ T-cell staining percentage and CD4+/Treg ratio in harvested tumor tissue collected from prostatectomy specimen

Mean staining percentage of Annexin V in tumor tissue, using TUNEL (Terminal deoxynucleotidyl transferase dUTP nick end labeling) staining.

Pathological response is defined as the absence of tumor identification by study pathologist on standard histological analysis of resected prostate specimens.

Proportion of participants with PSA \<0.1ng/mL by 2 months after prostatectomy

Regeneron Pharmaceuticals

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participants will be treated with dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints.

Dupilumab: dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.

Dupixent Subcutaneous (SQ) Injection

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Kenneth Pienta, M.D.

Data could not be collected for this outcome measure due to COVID-19 pandemic restrictions.

Change in M2-TAM Infiltration From Baseline

Safety as Assessed by Number of Participants Experiencing Adverse Events

Only 6/7 participants had a prostatectomy.

Feasibility as Assessed by Number of Participants Who Have an Average Blood Loss in Excess of 2500 mL During Prostatectomy

Feasibility as Assessed by Number of Participants With Average Prostatectomy Operative Time in Excess of 3.5 Hours

Only 6/7 participants had a prostatectomy

Feasibility as Assessed by Number of Participants With Average Hospital Stay in Excess of 4 Days Post-prostatectomy

CD8+ T-cell Infiltration in Post-treatment Prostate Glands

CD4+ T-cell and Treg Infiltration in Post-treatment Prostate Glands

Expression of Apoptosis Marker (Annexin V) in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage in Tumor Tissue

Expression of Cell Proliferation in Post-treatment Prostate Tumor Specimen as Measured by Mean Staining Percentage of Ki-67 in Tumor Tissue

Proportion of Participants With Pathological Complete Response

Proportion of Participants Who Achieve an Undetectable PSA at 2 Months Post-prostatectomy

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cemiplimab

Antineoplastic Agents, Immunological

Participants will receive neoadjuvant subcutaneous Dupilumab 600mg and intravenous Cemiplimab 350mg on Day 1. Participants will proceed to standard of care surgery for early-stage, resectable NSCLC (within 7 days of Day 15), and will be observed for adverse events and dose limiting toxicities.

Dupilumab will be administered at the recommended initial dosage of 600 mg (two 300 mg injections) on Day 1.

Cemiplimab will be administered at the recommended dosage of 350 mg, as an intravenous infusion, over 30 minutes on Day 1.

Thomas Marron, MD, PhD

Katherine Vandris

Thomas Marron, MD PhD

Thomas Marron, MD

This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1, participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per standard of care, outside the context of this clinical treatment, and undergo subsequent standard of care monitoring for recurrence. The study team will monitor the status of the participant through chart review, or by telephone should the patient not continue to follow with a physician at Mount Sinai, for up to 5 years.

Phase 1b of the study will consist of a safety run-in phase following a modified 3+3 design without dose escalation using the treatment administration plan in protocol patients will be enrolled and monitored for dose-limiting toxicities (DLTs), from the start of treatment up to 30 days following the administration of dupilumab. Patients will be entered in escalating cohorts of 3 patients.

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

A Phase 1/2 Study of Combined Treatment With Dupilumab (Anti-IL-4Ra) and Cemiplimab (Anti-PD-1) in Patients With Early-stage, Resectable NSCLC

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Safety of treatment, defined as the frequency of dose limiting toxicities (DLTs), from start of treatment up to 30 days post the administration of dupilumab.

Safety of treatment, defined as the percentage of dose limiting toxicities (DLTs), from start of treatment up to 30 days post the administration of dupilumab.

Major pathological response (MPR), defined as the percentage of 90 percent or greater tumor necrosis at time of resection, as defined by expert thoracic pathologists.

Time to surgery defined as the time from the initial dose of dupilumab to the time of surgery, measured in days

Feasibility of treatment, defined as the frequency of treatment-related delay of curative-intent surgery, due to treatment-related Adverse Events (AEs), greater than 8 weeks following the administration of dupilumab

Defined as the time from initial treatment of dupilumab and cemiplimab to progression of disease, recurrence of tumor following surgery, or death from any cause regardless of etiology

Time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer	NCT03886493	Prostate Cancer	Dupilumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC	NCT06088771	Non-Small Cell ...	Dupilumab Cemiplimab	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for dupilumab

Every month we try and update this database with for dupilumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dupilumab

Every month we try and update this database with for dupilumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dupilumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.