Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer

NCT04186013 | Active Not Recruiting Phase 2

• 1 other identifier: SOGUG-2017-A-IEC(VEJ)-4
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 10

Brief Summary

Open, multicentre, phase II trial of atezolizumab with concurrent normofractionated radiotherapy in patients with localized muscle-invasive bladder cancer treated with a selective multimodality bladder conservative approach.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

  Response of grade 5 according to Miller and Payne criteria

  After the end of the treatment (16 weeks)

Secondary Outcomes (9)

• Overall survival

  through study completion, up to 5 years

• Disease specific survival

  through study completion, up to 5 years

• Disease free survival

  through study completion, up to 5 years

• Bladder-intact disease-free survival

  through study completion, up to 5 years

• Muscle invasive and non-muscle invasive local failure

  through study completion, up to 5 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Atezolizumab 1200 mg intravenous infusion every 3 weeks for a total of 6 doses combined with External Beam Radiation Therapy (EBRT) (dosage: 60 Gy in 30 fractions overs 6 weeks at 2Gy/day)

Drug: Atezolizumab Injection [Tecentriq]; Radiation: External Beam Radiation Therapy (EBRT)

Interventions

Atezolizumab Injection [Tecentriq] DRUG

intravenous infusion of 1.200 mg of Atezolizumab administered intravenously every 3 weeks for a total of 6 doses

Experimental arm

External Beam Radiation Therapy (EBRT) RADIATION

60 Gy of radiotherapy in 30 fractions overs 6 weeks at 2 Gy/day

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18 years of age or older.
• Patients have histologically-confirmed diagnosis of muscle-invasive urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0, who are not candidates for radical cystectomy by medical reasons, refusal or patient's choice.
• Patients who refuse treatment with cisplatin-based chemotherapy or in whom treatment with cisplatin-based therapy is not appropriate.
• Patients must have ECOG performance status 0 to 2.
• Patients must have adequate bone marrow function as defined by absolute neutrophil count \>1.500/mm3; platelets \>100.000/mm3 and HB ≥ 9g/dl.
• Patients must have adequate renal and liver function as defined by calculated creatinine clearance \>15ml/min.
• Total bilirubin, SGOT (AST) and/or SGPT (ALT) \< 2,5 times the upper limit of normal.
• International Normalized Ration (INR) or Prothrombin Time (PT): ≤1.5 X ULN unless participant is receiving anticoagulant therapy (as long as PT or PTT is within therapeutic range of intended use of anticoagulants).
• Activated Partial Thromboplastin Time (aPTT): ≤1.5 X ULN unless participant is receiving anticoagulant therapy (as long as PT or PTT is within therapeutic range of intended use of anticoagulants).
• Female participant of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registering the patient. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy (1).
• A paraffin-embedded tumour sample must be available for the associate molecular study.

You may not qualify if:

• Previous treatment with radiotherapy to the bladder, systemic chemotherapy or immune checkpoint inhibitors. Prior intravesical BCG treatment for non-muscle invasive bladder cancer is allowed.
• Presence of regional lymph node or metastatic extension of the disease.
• Concurrent treatment with other experimental drugs (within 30 days prior to study entry) or other anti-cancer therapy.
• History of prior malignancies within the preceding 5 years other than previously treated basal cell carcinoma of the skin, non-muscle invasive bladder cancer, incidental prostate carcinoma Stage T1a well differentiated prostatic carcinoma in men (Gleason = 3+3, PSA \<5) and carcinoma in situ of the cervix.
• Evidence of tumour-related moderate/severe hydronephrosis unless stented or with nephrostomy to preserve renal function.
• Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative chemoradiotherapy.
• Bulky T3/T4a tumours unsuitable for curative treatment (i.e. \> 5 cm in any dimension). Tumours measures must be done post-TUR via CT scan.
• Patients with serious uncontrolled infection.
• Has a known history of active BT (Bacillus Tuberculosis).
• Has known history of, or any evidence of active, non-infectious pneumonitis.
• Autoimmune diseases other than vitiligo, type I diabetes mellitus, residual hypothyroidism requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
• Positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid antibody (HCV-Ab) indicating acute or chronic infection.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Subjects with a condition requiring systemic treatment with either corticosteroids (equivalent to \> 10 mg/day prednisone) or other immune-suppressive medications within 14 days of study drug administration.
• Women of child-bearing potential unwilling to be abstinent or use effective methods of birth control.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Roche Farma, S.A: collaborator
• Dynamic Science S.L.: collaborator

Study Sites (10)

Althaia Xarxa Assintencial

Manresa, Barcelona, 08243, Spain

Location

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, 43204, Spain

Location

Hospital Clínico Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital HM Sanchinarro

Madrid, 28050, Spain

Location

Complejo Hospitalario Universitario Ourense

Ourense, 32005, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Arnau de Vilanova

Valencia, 6015, Spain

Location

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Related Links

• Clinical Trial Facilitation Group. Recommendations related to contraception and pregnancy testing in clinical trials. Clinical Trial Facilitation Group. Recommendations related to contraception and pregnancy testing in clinical trials. 2014
• Web page of the sponsor of the study

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 4, 2019
• Study Start: September 18, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)