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PD-L1 Inhibitor

nab-paclitaxel for Breast Cancer (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

MARIO-3 Trial Summary

This trial tests combinations of drugs to fight cancer in people with TNBC & RCC.

Eligible Conditions
  • Breast Cancer
  • Kidney Cancer

MARIO-3 Trial Timeline

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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and pfs will be assessed from screening through month 12 for cohort a (tnbc) and from screening through month 18 for cohort b (rcc). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR) rate (change in target lesion size).
Secondary outcome measures
Changes from baseline in blood pressure
Changes from baseline in electrocardiograms (ECGs)
Changes from baseline in pulse rate
+13 more

Side effects data

From 2017 Phase 4 trial • 143 Patients • NCT02151149
56%
Anaemia
53%
Nausea
53%
Fatigue
46%
Neutropenia
43%
Peripheral sensory neuropathy
41%
Alopecia
37%
Diarrhoea
37%
Decreased appetite
29%
Vomiting
29%
Constipation
27%
Thrombocytopenia
24%
Dehydration
24%
Hypokalaemia
24%
Dyspnoea
20%
Hypomagnesaemia
20%
Dizziness
19%
Weight decreased
19%
Oedema peripheral
19%
Neutrophil count decreased
19%
Muscular weakness
19%
Hypotension
17%
Cough
16%
Peripheral motor neuropathy
16%
Leukopenia
14%
Arthralgia
14%
Dysgeusia
14%
Anxiety
14%
Epistaxis
13%
Abdominal pain
11%
Stomatitis
11%
Rash maculo-papular
11%
Pain in extremity
10%
White blood cell count decreased
10%
Fall
10%
Pyrexia
10%
Back pain
10%
Headache
9%
Gastrooesophageal reflux disease
9%
Platelet count decreased
9%
Chills
9%
Urinary tract infection
7%
Non-cardiac chest pain
7%
Dysphagia
7%
Hypocalcaemia
7%
Pneumonia
7%
Hyperglycaemia
6%
Dry skin
6%
Vision blurred
6%
Dysphonia
6%
Hypertension
6%
Insomnia
6%
Blood creatinine increased
4%
Musculoskeletal chest pain
4%
Atrial fibrillation
4%
Asthenia
4%
Upper respiratory tract infection
3%
Delirium
3%
Pulmonary embolism
3%
Mental status changes
3%
Pleural effusion
3%
Syncope
3%
Chronic obstructive pulmonary disease
1%
Ileus
1%
Deep vein thrombosis
1%
Pain
1%
Spinal column stenosis
1%
Seizure
1%
Cardiac arrest
1%
Febrile neutropenia
1%
Small intestinal obstruction
1%
Acute kidney injury
1%
Cachexia
1%
Hypoxia
1%
Hyponatraemia
1%
Oropharyngeal pain
1%
Diverticulitis
1%
Chest pain
1%
Atrial thrombosis
1%
Haemoptysis
1%
Pancreatitis acute
1%
Acute respiratory failure
1%
Atrial flutter
1%
Pancreatitis
1%
Leukocytosis
1%
Pericardial effusion
1%
Myocardial infarction
1%
Rectal haemorrhage
1%
Bronchitis
1%
Bone pain
1%
Encephalopathy
1%
Respiratory failure
1%
Overdose
1%
Contusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle)
Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce)

MARIO-3 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
~1330
IPI-549 (eganelisib)
2019
Completed Phase 2
~50
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Infinity Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
1,375 Total Patients Enrolled
1 Trials studying Breast Cancer
29 Patients Enrolled for Breast Cancer
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,705 Total Patients Enrolled
28 Trials studying Breast Cancer
13,765 Patients Enrolled for Breast Cancer
Halle Zhang, PhD, RNStudy DirectorMedical Lead
2 Previous Clinical Trials
268 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma
2019. "Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03961698.
All > Renal Cell Carcinoma
~17 spots leftby Apr 2025
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