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PD-1 Inhibitor

Nivolumab/Lirilumab for Bladder Cancer (PrE0807 Trial)

Phase 1
Waitlist Available
Research Sponsored by PrECOG, LLC.
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 24 months
Awards & highlights

PrE0807 Trial Summary

This trial will test whether a combination of two drugs, nivolumab and lirilumab, can help treat patients with muscle-invasive bladder cancer who cannot receive cisplatin or who refuse cisplatin therapy.

Eligible Conditions
  • Bladder Cancer

PrE0807 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE V5.0
Secondary outcome measures
Complete Response Rate
Two Year Recurrence-free Survival

Side effects data

From 2022 Phase 1 trial • 43 Patients • NCT03532451
23%
NAUSEA
23%
FATIGUE
15%
URINARY INCONTINENCE
15%
ANOREXIA
15%
ARTHRALGIA
8%
URINARY TRACT INFECTION
8%
CONSTIPATION
8%
DRY MOUTH
8%
FLANK PAIN - RIGHT SIDE
8%
LOCALIZED EDEMA - R GROIN
8%
LYMPHOCELE
8%
MYALGIA
8%
PUFFINESS IN LOWER ABDOMEN
8%
RASH MACULO-POPULAR - ARMS AND LEGS
8%
RASH MACULO-POPULAR - BACK, CHEST, ABDOMEN, R ARM
8%
SWOLLEN TESTIS
8%
THRUSH
8%
VAGINAL INFECTION - FUNGAL
8%
HAIR THINNING
8%
HICCUPS
8%
PAIN - STOMA SITE
8%
URINARY RETENTION
8%
URINE OUTPUT DECREASED - INTERMITTENT
8%
DECREASE RBC
8%
HYPOTENSION - INTERMITTENT
8%
INFUSION REACTION
8%
RASH
8%
WEIGHT LOSS
8%
HEMATOCHEZIA
8%
ADULT RESPIRATORY SYNDROME
8%
ABDOMINAL PAIN
8%
ACUTE KIDNEY INJURY
8%
ANAL PAIN
8%
ASCITES
8%
BACK PAIN
8%
BILATERAL KNEE SWELLING
8%
DIARRHEA
8%
INTERMITTENT HEADACHES
8%
PAIN IN EXTREMITY - R ARM
8%
PELVIC PAIN
8%
PRESSURE ULCER ON COCCYX
8%
PRURITUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Nivolumab
Cohort 2: Nivolumab/Lirilumab

PrE0807 Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Nivolumab/LirilumabExperimental Treatment1 Intervention
Nivolumab 480 mg IV and Lirilumab 240 mg on week 0 and week 4
Group II: Cohort 1: NivolumabExperimental Treatment1 Intervention
Nivolumab 480 mg IV on week 0 and week 4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Nivolumab/Lirilumab
2019
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

PrECOG, LLC.Lead Sponsor
17 Previous Clinical Trials
7,415 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,421 Total Patients Enrolled
Petros Grivas, MD, PhDStudy ChairUniversity of Washington

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
Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
2019. "Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532451.
~7 spots leftby Apr 2025
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