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Monoclonal Antibodies
INCMGA00012 + Pelareorep for Triple Negative Breast Cancer
Phase 2
Recruiting
Led By Mridula A George
Research Sponsored by Mridula George, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Metastatic or inoperable locally advanced, histologically documented triple negative breast cancer (TNBC) (negative expression of estrogen receptor [ER], progesterone receptor [PR] and human epidermal growth factor receptor 2 [HER2] immunohistochemistry [IHC] 0 or 1+, HER2 fluorescence in situ hybridization [FISH] negative if IHC 2+, per American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines)
Patients who have received adjuvant therapy for locally advanced triple negative breast cancer may be eligible for the study if they relapse with metastatic disease within 6 months since completion of neo-adjuvant/adjuvant systemic therapy. The adjuvant/neoadjuvant therapy will be considered as 1 line of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 weeks after completion of treatment
Awards & highlights
Study Summary
This trial will test the combination of INCMGA00012 and pelareorep to treat patients with metastatic triple negative breast cancer.
Who is the study for?
This trial is for women with metastatic triple negative breast cancer who've had 1-2 prior systemic therapies. They must not be pregnant, have certain blood and organ function levels within set limits, and agree to use two forms of contraception if of childbearing potential. Exclusions include lung disease history, more than three prior treatments in the metastatic setting, known severe allergies to study drugs or components, recent serious cardiovascular events, untreated brain metastases among others.Check my eligibility
What is being tested?
The IRENE Study is testing INCMGA00012 (a monoclonal antibody targeting PD-1) combined with pelareorep (a naturally occurring virus that may destroy cancer cells) against metastatic triple negative breast cancer. The phase 2 trial aims to assess safety and effectiveness while also requiring quality-of-life assessments through questionnaires.See study design
What are the potential side effects?
Potential side effects could include immune system reactions due to INCMGA00012's action on PD-1 which might cause inflammation in various organs. Pelareorep being a virus could lead to flu-like symptoms or other infection-related issues. Specific side effects will depend on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is advanced, cannot be removed by surgery, and lacks ER, PR, and HER2.
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My triple negative breast cancer returned as metastatic within 6 months after completing initial treatment.
Select...
I had brain metastases treated over a month ago, am off steroids, and my brain scans are stable.
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I am a woman who could become pregnant and have a negative pregnancy test.
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I am not postmenopausal or surgically sterile and have a negative pregnancy test.
Select...
I agree to use two effective birth control methods during and 12 weeks after the study.
Select...
My blood thinner medication has been stable for the last 14 days.
Select...
I have been treated with anti-PD-1 or anti-PD-L1 inhibitors before.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can provide a tumor sample and am willing to have two biopsies.
Select...
I have had 1-2 treatments for advanced triple negative breast cancer.
Select...
My liver enzymes are within acceptable limits for the trial.
Select...
My cancer can be measured by scans according to specific criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 8 weeks after completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 8 weeks after completion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Objective response rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Overall survival (OS)
Progression free survival (PFS)
+1 moreOther outcome measures
Changes in PD-L1 expression
T-cell receptor (TCR) sequencing
Side effects data
From 2020 Phase 2 trial • 108 Patients • NCT0119926392%
Anemia
85%
Nausea
85%
Fatigue
81%
White Blood Cell Decreased
75%
Neutrophil Count Decreased
71%
Constipation
69%
Alopecia
63%
Chills
63%
Peripheral Sensory Neuropathy
58%
Platelet Count Decreased
58%
Dyspnea
52%
Fever
52%
Anorexia
52%
Diarrhea
48%
Hypoalbuminemia
46%
Abdominal Pain
46%
Vomiting
40%
Pain
38%
Hypertension
37%
Headache
37%
Hyperglycemia
35%
Flu Like Symptoms
35%
Cough
31%
Mucositis Oral
31%
Hypocalcemia
31%
Depression
29%
Hyponatremia
29%
Back Pain
29%
Edema Limbs
27%
Hypomagnesemia
27%
Creatinine Increased
25%
Myalgia
23%
Dizziness
23%
Insomnia
21%
Anxiety
21%
Urinary Tract Infection
19%
Bloating
19%
Arthralgia
19%
Generalized Muscle Weakness
19%
Nasal Congestion
17%
Hypokalemia
17%
Urinary Frequency
15%
Pruritus
15%
Non-Cardiac Chest Pain
15%
Aspartate Aminotransferase Increased
15%
Alkaline Phosphatase Increased
13%
Dehydration
13%
Pain In Extremity
13%
Hypotension
13%
Epistaxis
13%
Hot Flashes
12%
Rash Maculo-Papular
12%
Blurred Vision
12%
Urinary Tract Pain
12%
Alanine Aminotransferase Increased
12%
Flushing
10%
Sinus Tachycardia
10%
Neoplasms Benign, Malignant And Unspecified (Incl
10%
Atrial Fibrillation
10%
Abdominal Distension
10%
Sinusitis
10%
Hypophosphatemia
10%
Dry Skin
10%
Nail Loss
10%
Hyperkalemia
10%
Pleural Effusion
10%
Productive Cough
10%
Nail Discoloration
10%
Ascites
8%
Hoarseness
8%
Small Intestinal Obstruction
8%
Dysphagia
8%
Allergic Rhinitis
8%
Hypermagnesemia
8%
Lymphocyte Count Decreased
8%
Postnasal Drip
8%
Urinary Incontinence
8%
Weight Loss
8%
Thromboembolic Event
6%
Stomach Pain
6%
Enterocolitis Infectious
6%
Blood Bilirubin Increased
6%
Edema Face
6%
Vaginal Infection
6%
Weight Gain
6%
Sore Throat
6%
Hematuria
6%
Dysgeusia
6%
Inr Increased
6%
Activated Partial Thromboplastin Time Prolonged
6%
Hypoxia
6%
Localized Edema
4%
Lung Infection
4%
Intra-Abdominal Hemorrhage
4%
Flashing Lights
4%
Chest Pain - Cardiac
4%
Palpitations
4%
Tinnitus
4%
Gastroesophageal Reflux Disease
4%
Malaise
4%
Infusion Related Reaction
4%
Allergic Reaction
4%
Upper Respiratory Infection
4%
Skin Infection
4%
Hypoglycemia
4%
Sinus Disorder
4%
Confusion
4%
Chest Wall Pain
4%
Neck Pain
4%
Syncope
4%
Ear Pain
4%
Peripheral Motor Neuropathy
4%
Hyperhidrosis
4%
Acute Kidney Injury
2%
Infusion Site Extravasation
2%
Febrile Neutropenia
2%
Sinus Bradycardia
2%
Myocardial Infarction
2%
Purpura
2%
Gastritis
2%
Cataract
2%
Vaginal Hemorrhage
2%
Retinopathy
2%
Floaters
2%
Sepsis
2%
Intracranial Hemorrhage
2%
Ventricular Tachycardia
2%
Hip Fracture
2%
Gallbladder Pain
2%
Pharyngitis
2%
Dyspepsia
2%
Rectal Hemorrhage
2%
Oral Pain
2%
Flatulence
2%
Enterocolitis
2%
Wound Infection
2%
Anal Fistula
2%
Salivary Gland Infection
2%
Gum Infection
2%
Upper Gastrointestinal Hemorrhage
2%
Fecal Incontinence
2%
Mucosal Infection
2%
Conjunctivitis Infective
2%
Oral Hemorrhage
2%
Injection Site Reaction
2%
Gastroparesis
2%
Hepatobiliary Disorders - Other
2%
Gait Disturbance
2%
Pelvic Pain
2%
Gallbladder Obstruction
2%
Pulmonary Hypertension
2%
Nail Infection
2%
Nail Ridging
2%
Suicidal Ideation
2%
Acidosis
2%
Muscle Weakness Lower Limb
2%
Lymphedema
2%
Pain Of Skin
2%
Hypernatremia
2%
Respiratory Failure
2%
Palmar-Plantar Erythrodysesthesia Syndrome
2%
Sneezing
2%
Presyncope
2%
Paresthesia
2%
Akathisia
2%
Hypercalcemia
2%
Lethargy
2%
Arthritis
2%
Urinary Urgency
2%
Facial Muscle Weakness
2%
Ataxia
2%
Movements Involuntary
2%
Urinary Tract Obstruction
2%
Erythema Multiforme
2%
Superficial Thrombophlebitis
2%
Pneumothorax
2%
Watering Eyes
2%
Laryngitis
2%
Bladder Infection
2%
Postoperative Hemorrhage
2%
Fall
2%
Bruising
2%
Depressed Level Of Consciousness
2%
Cognitive Disturbance
2%
Pneumonitis
2%
Sleep Apnea
2%
Wheezing
2%
Adrenal Insufficiency
2%
Burn
2%
Chronic Kidney Disease
2%
Vaginal Pain
2%
Agitation
2%
Skin And Subcutaneous Tissue Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Paclitaxel and Wild-type Reovirus)
Arm I (Paclitaxel)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pelareorep, retifanlimab)Experimental Treatment4 Interventions
Patients receive pelareorep IV over 60 minutes on days 1, 2, 15, and 16. Patients also receive INCMGA00012 IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelareorep
2010
Completed Phase 2
~150
Retifanlimab
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,140 Total Patients Enrolled
9 Trials studying Breast Cancer
647 Patients Enrolled for Breast Cancer
Oncolytics BiotechIndustry Sponsor
20 Previous Clinical Trials
972 Total Patients Enrolled
1 Trials studying Breast Cancer
26 Patients Enrolled for Breast Cancer
Mridula George, MDLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
1 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had vaccines like the flu shot within the last 4 weeks.I have had cancer before, but it was either a non-dangerous skin cancer, a localized cancer that did not spread, or any cancer that I've been free of for over a year.I do not have active brain cancer that needs treatment, or I have small, symptom-free brain lesions.I have or had lung scarring or inflammation not caused by an infection.I have not needed strong medication for an autoimmune disease in the last 2 years.You have a history of mental illness or difficult living situations that might make it hard for you to follow the study rules. You also have a medical condition or are getting treatment that could affect the study results or make it difficult for you to take part in the whole study.Your lactate dehydrogenase (LDH) level is below twice the upper limit of normal.My side effects from previous treatments have mostly gone away, except for hair loss or mild anemia.Your hemoglobin level is 9.0 grams per deciliter or higher.I stopped a previous immune therapy due to severe side effects or needed long-term steroids.You have a known history of HIV or other serious weakened immune system.My triple negative breast cancer returned as metastatic within 6 months after completing initial treatment.Your bilirubin levels in your blood should not be too high, unless you have Gilbert's disease or liver metastases.I had brain metastases treated over a month ago, am off steroids, and my brain scans are stable.I am a woman who could become pregnant and have a negative pregnancy test.My breast cancer is advanced, cannot be removed by surgery, and lacks ER, PR, and HER2.I am not postmenopausal or surgically sterile and have a negative pregnancy test.I have had a stroke, heart attack, or severe heart symptoms in the last 6 months.I agree to use two effective birth control methods during and 12 weeks after the study.My blood thinner medication has been stable for the last 14 days.I have been treated with anti-PD-1 or anti-PD-L1 inhibitors before.I have been treated with pelareorep before.I have had a previous transplant of stem cells or an organ.I have undergone 4 or more treatments for my cancer after it spread.Your body has enough infection-fighting white blood cells.I can take care of myself and am up and about more than half of my waking hours.I can provide a tumor sample and am willing to have two biopsies.I have had 1-2 treatments for advanced triple negative breast cancer.Your doctor believes you are currently misusing alcohol or drugs.My liver enzymes are within acceptable limits for the trial.Your kidney function is not too low, and it's at least 40 milliliters per minute for every 1.73 square meters of body surface area.I haven't taken any experimental cancer treatments in the last 14 days.You are expected to live for at least 3 more months, as determined by the doctor.My cancer can be measured by scans according to specific criteria.I am receiving treatment for active hepatitis B or C.Your platelet count is at least 100,000 per microliter.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pelareorep, retifanlimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects have enrolled in this experiment?
"Correct. Information published on clinicaltrials.gov implies that this trial, which was first listed on July 13th 2020, is actively recruiting participants--25 at two different sites to be exact."
Answered by AI
What other investigations have been conducted utilizing Pelareorep?
"Acibadem Cityclinica Mhat Tokuda first evaluated pelareorep in 2016. Since then, 237 clinical studies have concluded with the current status of 26 active research projects; many within New Brunswick, NJ."
Answered by AI
Is this experiment an unprecedented medical investigation?
"Research into pelareorep began in 2016 with Incyte Corporation sponsoring the initial trial of 325 patients, which led to its Phase 1 drug approval. To this day there are 26 medical studies actively investigating it across 117 cities and 43 nations globally."
Answered by AI
Has the Federal Drug Administration sanctioned Pelareorep for use?
"Based on available data, the safety of pelareorep has been provisionally rated a 2. This is due to this being classified as a Phase 2 trial which suggests there are some studies advocating its safety but none that have assessed efficacy."
Answered by AI
Are there still openings available for individuals to partake in this research endeavor?
"Affirmative, the information found on clinicaltrials.gov reveals that this trial is actively seeking participants. It was initially posted in July 2020 and the details were last updated in September 2022; 25 volunteers are required from two medical sites."
Answered by AI
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