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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 prior treatment with anti-PD-1 or anti-PD-L1 inhibitors are eligible for the study
Must not have
Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis
Subjects previously treated with pelareorep
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 weeks after completion of treatment
Awards & highlights
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.
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.
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.
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 have had 1-2 treatments for advanced triple negative breast cancer.
Select...
My cancer can be measured by scans according to specific criteria.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had lung scarring or inflammation not caused by an infection.
Select...
I have been treated with pelareorep before.
Select...
I have had a previous transplant of stem cells or an organ.
Select...
I have undergone 4 or more treatments for my cancer after it spread.
Select...
I am receiving treatment for active hepatitis B or C.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Objective response rate (ORR)
Secondary study objectives
Duration of Response (DOR)
Overall survival (OS)
Progression free survival (PFS)
Other study objectives
Changes in PD-L1 expression
T-cell receptor (TCR) sequencing
Side effects data
From 2020 Phase 2 trial • 108 Patients • NCT0119926390%
Anemia
83%
Fatigue
73%
Nausea
73%
White Blood Cell Decreased
73%
Alopecia
63%
Peripheral Sensory Neuropathy
58%
Constipation
52%
Neutrophil Count Decreased
50%
Dyspnea
48%
Abdominal Pain
46%
Anorexia
44%
Hypoalbuminemia
42%
Diarrhea
42%
Vomiting
38%
Edema Limbs
38%
Depression
35%
Hyperglycemia
33%
Hypocalcemia
31%
Hyponatremia
31%
Hypertension
27%
Urinary Tract Infection
27%
Creatinine Increased
25%
Arthralgia
25%
Cough
23%
Platelet Count Decreased
23%
Aspartate Aminotransferase Increased
23%
Hypomagnesemia
23%
Headache
23%
Insomnia
21%
Bloating
21%
Mucositis Oral
21%
Hypokalemia
21%
Anxiety
21%
Rash Maculo-Papular
21%
Hot Flashes
19%
Pain
19%
Alkaline Phosphatase Increased
19%
Dehydration
19%
Generalized Muscle Weakness
19%
Dizziness
17%
Urinary Frequency
17%
Bone Pain
17%
Back Pain
15%
Blurred Vision
15%
Abdominal Distension
15%
Fever
15%
Alanine Aminotransferase Increased
15%
Nasal Congestion
13%
Small Intestinal Obstruction
13%
Tinnitus
13%
Dyspepsia
13%
Non-Cardiac Chest Pain
13%
Lymphocyte Count Decreased
13%
Pain In Extremity
13%
Pruritus
13%
Hypotension
10%
Ascites
10%
Localized Edema
10%
Urinary Urgency
10%
Urinary Tract Pain
10%
Sore Throat
10%
Postnasal Drip
10%
Allergic Rhinitis
10%
Nail Discoloration
8%
Urinary Incontinence
8%
Ear Pain
8%
Chills
8%
Weight Loss
8%
Weight Gain
8%
Activated Partial Thromboplastin Time Prolonged
8%
Hypernatremia
8%
Chest Wall Pain
8%
Dysgeusia
8%
Nail Loss
8%
Thromboembolic Event
8%
Flushing
6%
Palpitations
6%
Hearing Impaired
6%
Fall
6%
Blood Bilirubin Increased
6%
Hypophosphatemia
6%
Hypoglycemia
6%
Hyperkalemia
6%
Myalgia
6%
Proteinuria
4%
Eye Pain
4%
Chest Pain - Cardiac
4%
Cognitive Disturbance
4%
Sinus Tachycardia
4%
Cataract
4%
Dry Mouth
4%
Rectal Hemorrhage
4%
Gastroesophageal Reflux Disease
4%
Toothache
4%
Esophagitis
4%
Gastritis
4%
Esophageal Pain
4%
Flu Like Symptoms
4%
Allergic Reaction
4%
Upper Respiratory Infection
4%
Skin Infection
4%
Sinusitis
4%
Sepsis
4%
Bruising
4%
Inr Increased
4%
Hypermagnesemia
4%
Hypertriglyceridemia
4%
Tremor
4%
Flank Pain
4%
Arthritis
4%
Peripheral Motor Neuropathy
4%
Memory Impairment
4%
Dysphasia
4%
Restlessness
4%
Confusion
4%
Urinary Retention
4%
Hematuria
4%
Vaginal Hemorrhage
4%
Pleural Effusion
4%
Dry Skin
4%
Rash Acneiform
2%
Akathisia
2%
Extraocular Muscle Paresis
2%
Floaters
2%
Vaginal Discharge
2%
Colonic Perforation
2%
Stoma Site Infection
2%
Lung Infection
2%
Neoplasms Benign, Malignant And Unspecified (Incl
2%
Acute Kidney Injury
2%
Leukocytosis
2%
Acute Coronary Syndrome
2%
Flashing Lights
2%
Dysphagia
2%
Conjunctivitis
2%
Colitis
2%
Ileus
2%
Rectal Mucositis
2%
Gastric Hemorrhage
2%
Oral Pain
2%
Rectal Pain
2%
Esophageal Hemorrhage
2%
Malaise
2%
Edema Trunk
2%
Facial Pain
2%
Edema Face
2%
Infusion Related Reaction
2%
Soft Tissue Infection
2%
Peritoneal Infection
2%
Otitis Media
2%
Papulopustular Rash
2%
Esophageal Infection
2%
Bronchial Infection
2%
Fracture
2%
Cholesterol High
2%
Urine Output Decreased
2%
Hyperuricemia
2%
Hypercalcemia
2%
Acidosis
2%
Neck Pain
2%
Muscle Weakness Lower Limb
2%
Sinus Pain
2%
Agitation
2%
Urinary Tract Obstruction
2%
Pelvic Pain
2%
Vaginal Dryness
2%
Breast Pain
2%
Epistaxis
2%
Nail Ridging
2%
Palmar-Plantar Erythrodysesthesia Syndrome
2%
Bullous Dermatitis
2%
Lymphedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Paclitaxel)
Arm II (Paclitaxel and Wild-type Reovirus)
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
~160
Retifanlimab
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
57,027 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.
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