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PD-L1 Inhibitor

nab-paclitaxel for Kidney 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

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).

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

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 more

Side effects data

From 2017 Phase 4 trial • 143 Patients • NCT02151149

68%

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

Upper respiratory tract infection

Pain

Overdose

Dry skin

Gastrooesophageal reflux disease

Pyrexia

White blood cell count decreased

Musculoskeletal chest pain

Muscular weakness

Haemoptysis

Fall

Arthralgia

Oral candidiasis

Contusion

Dysphagia

Hypocalcaemia

Oropharyngeal pain

Pneumonia

Hypotension

Non-cardiac chest pain

Vision blurred

Syncope

Anxiety

Febrile neutropenia

Pulmonary embolism

Generalised oedema

Hyperbilirubinaemia

Serratia infection

Gallbladder obstruction

Diarrhoea infectious

Sepsis

Deep vein thrombosis

Renal failure

Chills

Dysphonia

Hypertension

Sinus tachycardia

Odynophagia

Atrial tachycardia

Gastrointestinal haemorrhage

Acute myocardial infarction

Atrial fibrillation

Femur fracture

Clostridium difficile colitis

Aspartate aminotransferase increased

Femoral neck fracture

Oesophageal candidiasis

Alanine aminotransferase increased

Hypoglycaemia

Blood alkaline phosphatase increased

Pneumonitis

Orthostatic hypotension

Blood creatinine increased

100%

80%

60%

40%

20%

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