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PI3K Inhibitor

Nivolumab for Bladder Cancer

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 first dosing to date to confirmed disease progression or death, assessed up to 48 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, IPI-549, to see if it is more effective than the current standard of care drug, nivolumab, in treating patients with advanced urothelial cancer.

Eligible Conditions
  • Bladder Cancer
  • Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dosing to date to confirmed disease progression or death, assessed up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dosing to date to confirmed disease progression or death, assessed up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) per RECISTv1.1
Secondary outcome measures
Changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance
Changes from baseline in blood pressure
Changes from baseline in electrocardiograms (ECGs)
+9 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IPI-549 + NivolumabExperimental Treatment2 Interventions
Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
Group II: Placebo + NivolumabActive Control2 Interventions
Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPI-549 (eganelisib)
2019
Completed Phase 2
~50
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,983 Total Patients Enrolled
Infinity Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
1,417 Total Patients Enrolled
Halle Zhang, PhD, RNStudy DirectorInfinity Pharmaceuticals, Inc.
2 Previous Clinical Trials
310 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
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
2019. "Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03980041.
~9 spots leftby Apr 2025
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