Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05203913

Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-04

32

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one. Chemotherapy will be administered weekly during radiotherapy. Radiotherapy will be performed from Monday to Friday for five weeks. Nivolumab will be administered for one year (13 infusions). Patients will have the complete tumour assessment by computed tomography scan (CT-scan) and cystoscopy up to 5 years after radiotherapy.

CONDITIONS

Official Title

Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Histologic diagnosis of predominantly urothelial carcinoma of the bladder, excluding small cell histology
  • Stage T2-T3 N0M0 bladder cancer based on TURBT, CT or MRI imaging
  • FDG-PET within 6 weeks before treatment showing no lymph node or metastatic disease
  • Attempted complete trans urethral resection of bladder tumor within 8 weeks before chemoradiotherapy or recent cystoscopy showing no residual disease
  • Life expectancy greater than 6 months
  • ECOG performance status of 1 or better
  • Prior primary cancer allowed if treated curatively at least 3 years ago without recurrence or if clinically indolent
  • Considered able to tolerate systemic chemotherapy combined with pelvic intensity-modulated radiation therapy
  • Able and willing to provide written informed consent
  • Women of childbearing potential must use highly effective contraception during and for 5 months after treatment; men must use contraception if sexually active with such women for 6 months after last chemotherapy dose
  • Adequate bone marrow, liver, and kidney function based on laboratory tests within 7 days before treatment
  • Total bilirubin ≤1.5 × upper limit of normal (ULN)
  • Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for liver involvement)
  • INR and PTT ≤1.5 × ULN, with close monitoring if on anticoagulants
  • Platelet count ≥100,000/mm3, hemoglobin >9 g/dL, absolute neutrophil count >1,500/mm3
  • Alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for liver involvement)
  • Creatinine clearance >40 ml/min (Cockcroft-Gault formula)
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for other urothelial tumors
  • Prior pelvic radiotherapy
  • Participation in another clinical trial with therapeutic intent within 28 days or five half-lives of another investigational drug
  • Other malignancies within 3 years prior to treatment except certain low-risk prostate cancers and cancers with negligible risk of metastasis or death
  • Pre-existing medical conditions that prevent treatment (e.g., previous severe immune-related adverse reactions)
  • History of severe allergic or hypersensitivity reactions to chimeric or humanized antibodies
  • History of autoimmune diseases except stable autoimmune hypothyroidism or controlled type I diabetes
  • Active tuberculosis
  • Women of childbearing potential must use highly effective contraception during and for 5 months after treatment; men must use contraception if sexually active with such women for 6 months after last chemotherapy dose
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
  • Use of systemic corticosteroids or immunosuppressive medications within 2 weeks before treatment
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Recent live vaccine within 4 weeks before first dose except certain vaccines
  • History or evidence of active pneumonitis or related lung conditions
  • Active infection requiring IV therapy
  • Recent therapeutic antibiotics within 2 weeks before treatment
  • Significant cardiovascular disease or recent cardiac events
  • Major surgery within 28 days before treatment or planned major surgery during study
  • Prior allogeneic stem cell or solid organ transplant
  • Any condition contraindicating investigational drug use or increasing risk of complications
  • Known HIV infection
  • Active hepatitis B or C
  • Unwilling or unable to provide consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Roberto iacovelli

Roma, Italy, 00168

Actively Recruiting

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Research Team

R

Roberto Iacovelli, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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