Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Ivermectin

Antiparasitic Agents

Patients receive ivermectin PO QD on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Ivermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week).

Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.

Balstilmab

Clinical Trial Navigator

Clinical Trial Recruitment Navigator

Yuan Yuan, MD, PhD

Monica Mita, MD

Stephen Shiao, MD, PhD

Yuan Yuan, MD

This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab may increase the effect of balstilimab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).

Patients receive ivermectin orally (PO) once daily (QD) on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 90 days and then periodically thereafter.

Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer

A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Balstilimab in Patients With Metastatic Triple Negative Breast Cancer With Expansion Cohort in PD-L1 Negative TNBC

Evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Proportion of participants that are programmed cell death ligand 1 (PD-L1) negative with confirmed complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Proportion of participants with confirmed complete response (CR) or partial response (PR) as measured by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1.

From start of therapy until first documentation of disease progression per RECIST 1.1 or death due to any cause.

From start of study treatment to date of death due to any cause. Patient's last known to be alive are censored at date of last contact.

Measured from the date of first objective response recorded (CR or PR) until progression per RECIST 1.1, death or last contact (censored). Patient's last known to be alive are censored at date of last contact.

Defined as progression-free for at least 6 months or CR or PR per RECIST 1.1.

Evaluated by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 per standardized EORTC scoring guidelines.

Agenus Inc.

Gateway for Cancer Research

Yuan Yuan

Medical Director, Breast Oncology DRG

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

COVID-19

Communicable Diseases

Coronavirus Infections

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasoconstrictor Agents

Losartan

Angiotensin II

Giapreza

Angiotensinogen

Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists

Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.

Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days

Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients

Placebo

Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients

Pedro Exman, MD

Maria del Pilar Diz, MD, PhD

Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19

This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.

The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.

We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.

Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection

Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19

no plan to share individual participant data

Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death

Severe Acute Respiratory Syndrome defined as oxygen saturation less than 93%

Severe Acute Respiratory Syndrome defined as respiratory rate higher than 24 incursion per minute

Incidence of hepatic toxicity (elevation of ALT, AST above the upper limit of normal, measured by U/L)

Incidence of hepatic toxicity (elevation of bilirubin above the upper limit of normal, measured by mg/dL)

Incidence of renal toxicity (elevation of serum creatinine levels above the upper limit of normal, measured by mg/dL)

Incidence of symptomatic postural hypotension, diagnosed by clinical assessment of reduction of \> 20 mmHG of arterial systolic pressure after measurement in prone position and orthostatic position.

Death of any cause since protocol enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ivermectin and Balstilimab for the Treatment of Metastatic Triple Negative Breast Cancer	NCT05318469	Anatomic Stage ... Metastatic Trip...	Ivermectin Balstilmab	18 Years -	Cedars-Sinai Medical Center
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection	NCT04447235	Cancer COVID Coronavirus Inf...	Placebo Ivermectin Losartan	18 Years -	Instituto do Cancer do Estado de São Paulo
Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection	NCT04447235	Cancer COVID Coronavirus Inf...	Placebo Ivermectin Losartan	18 Years -	Instituto do Cancer do Estado de São Paulo

Spots Global Cancer Trial Database for ivermectin

Every month we try and update this database with for ivermectin 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 ivermectin

Every month we try and update this database with for ivermectin 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 ivermectin 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.