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PD-L1 Inhibitor
Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3 Trial)
Phase 2
Waitlist Available
Research Sponsored by Infinity Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dor will be assessed from screening through month 12 for cohort a (tnbc) and from screening through month 18 for cohort b (rcc).
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new pill called IPI-549 combined with other drugs to treat advanced breast and kidney cancers. It aims to block cells that help tumors grow, boosting the body's immune response to fight the cancer.
Eligible Conditions
- Breast Cancer
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pfs will be assessed from screening through month 12 for cohort a (tnbc) and from screening through month 18 for cohort b (rcc).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pfs will be assessed from screening through month 12 for cohort a (tnbc) and from screening through month 18 for cohort b (rcc).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR) rate (change in target lesion size).
Secondary study objectives
Changes from baseline in blood pressure
Changes from baseline in electrocardiograms (ECGs)
Changes from baseline in pulse rate
+13 moreSide effects data
From 2017 Phase 4 trial • 143 Patients • NCT0215114968%
Fatigue
66%
Anaemia
59%
Peripheral sensory neuropathy
51%
Neutropenia
47%
Nausea
44%
Thrombocytopenia
43%
Diarrhoea
40%
Alopecia
37%
Constipation
32%
Decreased appetite
24%
Cough
24%
Dyspnoea
24%
Epistaxis
24%
Dehydration
21%
Leukopenia
21%
Stomatitis
21%
Neutrophil count decreased
21%
Dizziness
19%
Vomiting
18%
Oedema peripheral
16%
Hyponatraemia
15%
Hypokalaemia
13%
Abdominal pain
13%
Platelet count decreased
13%
Weight decreased
12%
Hypomagnesaemia
12%
Back pain
12%
Insomnia
12%
Rash maculo-papular
10%
Urinary tract infection
10%
Hyperglycaemia
10%
Pain in extremity
10%
Headache
10%
Asthenia
10%
Dysgeusia
10%
Peripheral motor neuropathy
9%
Upper respiratory tract infection
9%
Pain
9%
Overdose
9%
Dry skin
7%
Gastrooesophageal reflux disease
7%
Pyrexia
7%
White blood cell count decreased
7%
Musculoskeletal chest pain
7%
Muscular weakness
7%
Haemoptysis
7%
Fall
7%
Arthralgia
6%
Contusion
6%
Oral candidiasis
6%
Dysphagia
6%
Hypocalcaemia
6%
Oropharyngeal pain
6%
Pneumonia
6%
Hypotension
4%
Non-cardiac chest pain
4%
Vision blurred
3%
Syncope
3%
Anxiety
3%
Febrile neutropenia
3%
Pulmonary embolism
1%
Generalised oedema
1%
Hyperbilirubinaemia
1%
Serratia infection
1%
Gallbladder obstruction
1%
Diarrhoea infectious
1%
Sepsis
1%
Deep vein thrombosis
1%
Renal failure
1%
Chills
1%
Dysphonia
1%
Hypertension
1%
Sinus tachycardia
1%
Odynophagia
1%
Atrial tachycardia
1%
Gastrointestinal haemorrhage
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Femur fracture
1%
Clostridium difficile colitis
1%
Aspartate aminotransferase increased
1%
Femoral neck fracture
1%
Oesophageal candidiasis
1%
Alanine aminotransferase increased
1%
Hypoglycaemia
1%
Blood alkaline phosphatase increased
1%
Pneumonitis
1%
Orthostatic hypotension
1%
Blood creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)
Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B (RCC)Experimental Treatment3 Interventions
IPI-549 in combination with front-line treatment. Cohort B will include two sub-cohorts: Cohorts B1 and B2.
Cohort B1: Approximately 15 patients with locally advanced and/or metastatic RCC, with PDL1 positive disease based on IHC defined as IC1/2/3.
Cohort B2: Approximately 15 patients with locally advanced and/or metastatic RCC, with PDL1 negative disease based on IHC defined as IC0.
Group II: Cohort A (TNBC)Experimental Treatment3 Interventions
IPI-549 in combination with front-line treatment. Cohort A will include two sub-cohorts: Cohorts A1 and A2.
Cohort A1: Approximately 30 patients with locally advanced and/or metastatic TNBC with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) defined as IC1/2/3.
Cohort A2: Approximately 30 patients with locally advanced and/or metastatic TNBC with PDL1 negative disease based on IHC defined as IC0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-paclitaxel
2008
Completed Phase 4
~1420
IPI-549 (eganelisib)
2019
Completed Phase 2
~50
Atezolizumab
2016
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
Infinity Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
1,375 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
411 Previous Clinical Trials
411,419 Total Patients Enrolled
Halle Zhang, PhD, RNStudy DirectorMedical Lead
2 Previous Clinical Trials
268 Total Patients Enrolled
Feng Chi, PhD, RNStudy DirectorMedical Lead