Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer
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|ClinicalTrials.gov Identifier: NCT04186013|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2019
Last Update Posted : October 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: Atezolizumab Injection [Tecentriq] Radiation: External Beam Radiation Therapy (EBRT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer (Study ATEZOBLADDERPRESERVE)|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||February 2027|
|Estimated Study Completion Date :||May 2027|
Experimental: Experimental arm
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]
intravenous infusion of 1.200 mg of Atezolizumab administered intravenously every 3 weeks for a total of 6 doses
Radiation: External Beam Radiation Therapy (EBRT)
60 Gy of radiotherapy in 30 fractions overs 6 weeks at 2 Gy/day
- Pathological complete response [ Time Frame: After the end of the treatment (16 weeks) ]Response of grade 5 according to Miller and Payne criteria
- Overall survival [ Time Frame: through study completion, up to 5 years ]Time from the date of the beginning of protocol therapy to the date of death due to any cause
- Disease specific survival [ Time Frame: through study completion, up to 5 years ]Time from start of treatment to the date of having evidence of distant metastases, nodal recurrence or recurrence within the radiotherapy field that could be salvaged in a curative fashion, what happens first
- Disease free survival [ Time Frame: through study completion, up to 5 years ]Time from the date of start of protocol therapy to the date of recurrence of muscle invasive or non-invasive bladder carcinoma or metastases, what happens first
- Bladder-intact disease-free survival [ Time Frame: through study completion, up to 5 years ]Time from the date of initiation of protocol therapy until the development of MIBC recurrence, regional pelvic recurrence, distant metastases, bladder cancer-related death or cystectomy, what happens first
- Muscle invasive and non-muscle invasive local failure [ Time Frame: through study completion, up to 5 years ]defined as patients that do not achieve a pCR defined as a response of grade 5 according to Miller and Payne criteria and documented tumour recurrence after pCR
- Rate of distant metastases [ Time Frame: through study completion, up to 5 years ]Percentage of patients who develop distant metastases. Defined as lymphonodal involvement above the bifurcation of the iliac vessels or in inquinal regions and metastases resulting from hematogenous spread
- Rate of patients with bladder preserved [ Time Frame: through study completion, up to 5 years ]Rate of patients with bladder preserved at the time of the biopsy of the tumour performed between one and two months after the last dose of atezolizumab
- Rate of immediate or late salvage cystectomy [ Time Frame: through study completion, up to 5 years ]Immediate will be evaluated at the time of the biopsy of the tumour performed between one and two months after the last dose of atezolizumab and late will be evaluated during the follow-up
- The safety profile and tolerability of the combination of atezolizumab with concurrent radiotherapy [ Time Frame: through study completion, up to 5 years ]Collection of any adverse events and serious adverse events
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
- General medical or psychological conditions that would preclude appropriate informed consent or compliance with the protocol.
(1) Acceptable methods of effective contraception:
- Complete sexual abstinence for 14 days before the start of study treatment to 5 months after completion of the investigational treatment.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), or tubal ligation at least six weeks before taking study treatment.
- Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.
- Intrauterine device or system with a documented failure less than 1%.
- Double barrier method with spermicide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186013
|Althaia Xarxa Assintencial|
|Manresa, Barcelona, Spain, 08243|
|Consorci Corporació Sanitària Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital Universitario Sant Joan de Reus|
|Reus, Tarragona, Spain, 43204|
|Hospital Clínico Universitario San Cecilio|
|Granada, Spain, 18016|
|Hospital Universitario Lucus Augusti|
|Lugo, Spain, 27003|
|Hospital Universitario La Princesa|
|Madrid, Spain, 28006|
|Hospital HM Sanchinarro|
|Madrid, Spain, 28050|
|Complejo Hospitalario Universitario Ourense|
|Orense, Spain, 32005|
|Hospital Universitario Central de Asturias|
|Oviedo, Spain, 33011|
|Hospital Arnau de Vilanova|
|Valencia, Spain, 6015|
Publications of Results:
|Responsible Party:||Spanish Oncology Genito-Urinary Group|
|Other Study ID Numbers:||
|First Posted:||December 4, 2019 Key Record Dates|
|Last Update Posted:||October 26, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Urinary Bladder Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urinary Bladder Diseases
Male Urogenital Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological