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Oleclumab for Bladder Cancer

Phase 1
Waitlist Available
Led By Guru P Sonpavde, MD
Research Sponsored by Dana-Farber Cancer Institute
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 2 years
Awards & highlights

Study Summary

A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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 Receiving at least One Dose of Study Therapy Followed by Surgery without Dose-Limiting Toxicity (DLT) up to Twelve Weeks Post-Radical Cystectomy (RC)
Secondary outcome measures
Duration of Time of RC to Time of Documented Disease Relapse or Recurrence after RC
Number of Participants Receiving at least One Cycle of Study Therapy and Undergone RC Having <pT2N0 Disease at Time of RC
Radiographic Progression by RECIST 1.1 Criteria from Time of Baseline Screening Imaging to the End of Treatment Imaging Pre-RC

Side effects data

From 2023 Phase 2 trial • 59 Patients • NCT04089553
45%
Nausea
24%
Fatigue
21%
Decreased appetite
17%
Blood creatinine increased
14%
Urinary tract infection
14%
Constipation
14%
Diarrhoea
14%
Vomiting
14%
Dizziness
10%
Blood alkaline phosphatase increased
10%
Anaemia
10%
Muscular weakness
10%
Oedema peripheral
10%
Insomnia
10%
Abdominal pain
10%
Back pain
7%
Peripheral sensory neuropathy
7%
Chills
7%
Muscle spasms
7%
Confusional state
7%
Hypoxia
7%
Pain
3%
Tooth infection
3%
Covid-19
3%
Hypertension
3%
Cachexia
3%
Aspartate aminotransferase increased
3%
Infusion site extravasation
3%
Localised oedema
3%
Skin infection
3%
Hallucination
3%
Hyperglycaemia
3%
Non-cardiac chest pain
3%
Agitation
3%
Dyspnoea
3%
Lipase increased
3%
Hip fracture
3%
Rash maculo-papular
3%
Procedural pain
3%
Skin laceration
3%
Alanine aminotransferase increased
3%
Amylase increased
3%
Hyperkalaemia
3%
Hyperuricaemia
3%
Hypocalcaemia
3%
Hypokalaemia
3%
Musculoskeletal chest pain
3%
Myalgia
3%
Pain in extremity
3%
Tendonitis
3%
Spinal cord compression
3%
Transient ischaemic attack
3%
Acute kidney injury
3%
Haematuria
3%
Acute respiratory failure
3%
Pneumonitis
3%
Chronic kidney disease
3%
Cough
3%
Dermatitis
3%
Pruritus
3%
Gastrooesophageal reflux disease
3%
Haemorrhoidal haemorrhage
3%
Haemorrhoids
3%
Blood lactate dehydrogenase increased
3%
International normalised ratio increased
3%
Weight decreased
3%
Arthralgia
3%
Sinus tachycardia
3%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Durvalumab + OleclumabExperimental Treatment2 Interventions
Durvalumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle Oleclumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle
Group II: DurvalumabExperimental Treatment1 Intervention
-Durvalumab will be administered intravenously every 2 weeks, with 14 consecutive days defined as a treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleclumab
2015
Completed Phase 2
~880
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,256 Previous Clinical Trials
288,593,624 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,860 Total Patients Enrolled
Guru P Sonpavde, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
24 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
A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)
Xiao X. Wei 2019. "A Feasibility Study of Durvalumab +/- Oleclumab as Neoadjuvant Therapy for Muscle-invasive Bladder Cancer (BLASST-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03773666.
~2 spots leftby Apr 2025
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