Neoplasms

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Immune Checkpoint Inhibitors

Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.

• Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.

Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.

IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.

IRX 2

This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).

This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).

A commonly used standard neoadjuvant regimen for TNBC is a weekly taxane (e.g., paclitaxel 80mg/m2) for 12 weeks followed by an anthracycline (e.g., doxorubicin 60 mg/m2 plus cyclophosphamide at 600 mg/m2 \[AC\]) every 3 weeks (Q3W) for 4 cycles.

The chemotherapy regimen included in this study is built upon the aforementioned regimen. Pembrolizumab in combination with this regimen will be studied as part of a multi-arm study that randomizes subjects to receive:

* Control Arm: (Pembro + ACT): Pembrolizumab induction (single-dose 200mg IV), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
* Arm A: (Pembro + IRX-2 + ACT): Pembrolizumab (single-dose 200mg IV) + cyclophosphamide (single-dose 300 mg/m2 IV) + IRX-2 induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab Q3W + paclitaxel (T) weekly x 4 cycles, followed by IRX-2 re-induction (1mL SQ x 2 daily, x 10 days), followed by pembrolizumab + doxorubicin + cyclophosphamide (AC) Q3W x 4 cycles as neoadjuvant therapy prior to surgery.
* Subsequent induction therapy arms are to be included in protocol amendments. Note: 1 cycle = 21 days

Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer

Induction Immunotherapy to Promote Immunologic Priming and Enhanced Response to Neoadjuvant Pembrolizumab + Chemotherapy in Triple Negative Breast Cancer (TNBC)

pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.

Tumor infiltrating lymphocytes will be assessed by the San Antonio stromal TIL criteria. (Salgado 2015). Scores will be reported as an average of two blinded pathologist reads.

Merck Sharp & Dohme LLC

Brooklyn ImmunoTherapeutics, LLC

Providence Health & Services

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Nivolumab

IRX-2 Regimen (4 ml) combined with Nivolumab (240 mg)

IRX-2 Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. This 21 day regimen will be given every 12 weeks.

Nivolumab 240 mg will be given via IV infusion once every 2 weeks.

Rohit Jain, MD, MPH

This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.

The first phase of this trial is to establish the safety of IRX-2 Regimen combined with Nivolumab. The IRX-2 Regimen is a 21-day regimen of cyclophosophamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. If no dose limiting toxicities (DLTs) are observed during the first 4 weeks of treatment, the enrollment will continue in a dose expansion phase. If there is a study treatment related DLT in 1 of 6 patients, the same dose will be investigated at the dose expansion cohorts. If study treatment related DLT is observed in 2 of 6 patients, accrual will be stopped and new dose levels or treatment sequences will be considered.

IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors

The IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity

A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.

Objective response determined using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.

Progression free survival defined as the time from Day 1 of treatment to evidence of progression. Progression will be defined by RECIST Version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer	NCT04373031	Breast Cancer Breast Neoplasm...	Pembrolizumab IRX 2	18 Years -	Providence Health & Services
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors	NCT03758781	Metastatic Canc... Recurrent Cance... Solid Tumor Renal Cell Carc... Urothelial Carc... NSCLC Squamous Cell C... Non-Small Cell ... Squamous Cell C...	IRX 2 Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors	NCT03758781	Metastatic Canc... Recurrent Cance... Solid Tumor Renal Cell Carc... Urothelial Carc... NSCLC Squamous Cell C... Non-Small Cell ... Squamous Cell C...	IRX 2 Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors	NCT03758781	Metastatic Canc... Recurrent Cance... Solid Tumor Renal Cell Carc... Urothelial Carc... NSCLC Squamous Cell C... Non-Small Cell ... Squamous Cell C...	IRX 2 Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for irx 2

Every month we try and update this database with for irx 2 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 irx 2

Every month we try and update this database with for irx 2 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 irx 2 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.