Efficacy and Safety of the Combination of Cisplatin Plus Nab-paclitaxel and Nivolumab With Radiotherapy After Maximal Tumor Resection in Non-metastatic Muscle Invasive Bladder Cancer.

Who is this study for? Patients with non-metastatic muscle invasive bladder cancer
What treatments are being studied? Nivolumab+Nab paclitaxel+Cisplatin+Radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years old or older

• Histologic diagnosis of predominantly urothelial carcinoma of the bladder. Focal differentiation allowed other than small cell histology.

• Stage T2-T3 N0M0 (AJCC-TNM version 6) based on trans-urethral resection of bladder tumor (TURBT), CT or MRI imaging, +/- bimanual examination under anaesthesia.

• FDG-PET within 6 weeks from the start of treatments, showing no evidence of lymph nodes or metastatic disease.

• Attempt of complete trans urethral resection of bladder tumour (TURBT) within 56 days (8 weeks) prior to the start of chemoradiotherapy. If TURBT was performed \> 8 weeks prior but a recent cystoscopy shows no residual disease, then a repeat TURBT is not necessary.

• Life expectancy greater than 6 months

• Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better

• Another primary cancer is allowed only if treated with curative intent at least 3 years prior to enrolment without evidence of recurrence or if the untreated cancer is clinically indolent (e.g., lower risk prostate cancer).

• Patients must be considered able to tolerate systemic chemotherapy combined with pelvic intensity-modulated radiation therapy (IMRT) by the joint agreement of the participating radiation oncologist and medical oncologist.

⁃ Able and willing to give written informed consent.

⁃ For women of childbearing potential (WOCBP), study participants must use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) for at least 5 months after the last dose of study intervention. Men receiving any study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of chemotherapy with cisplatin or nab-paclitaxel.

⁃ The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care. Acceptable methods are oral contraceptives, hormonal implants, hormonal patches, IDU, Diaphragm with spermicides, cervical cape with spermicide, and condom with spermicide.

⁃ Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:

⁃ Total bilirubin ≤1∙5 × the upper limit of normal (ULN).

⁃ Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer).

⁃ International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring with at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.

⁃ Platelet count ≥100 000/mm3, haemoglobin \>9 g/dl, absolute neutrophil count \>1,500/mm3.

⁃ Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).

⁃ Creatinine clearance greater than 40 ml/min as evaluated by Cockcroft-Gault formula.

Locations
Other Locations
Italy
Roberto iacovelli
RECRUITING
Roma
Contact Information
Primary
Roberto Iacovelli, MD, PhD
roberto.iacovelli@policlinicogemelli.it
+390630157373
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 32
Treatments
Experimental: Experimental arm
This arm consists in treatment with cisplatin + nab-paclitaxel + nivolumab during radiotherapy on bladder followed by nivolumab alone after the end of radiotherapy
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov

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