Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract

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Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy The Cxbladder Monitoring Study Avelumab in Combination With AVB-S6-500 in Patients With Advanced Urothelial Carcinoma A Study of the Safety of Atezolizumab in Patients With Advanced or Metastatic Urothelial Carcinoma in Argentina A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Locally Advanced and Metastatic Urothelial Carcinoma Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy An Expanded Access Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium Application of UCAD for Diagnosing Urothelial Carcinoma. A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma Diagnostic Values of Urothelial Carcinomas: Single-bolus Versus Split-bolus Computed Tomography Urography Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma BIBF1120 in Patients With Advanced FGFR3 Mutated,Overexpressed,or Wild Type Urothelial Carcinoma Gemcitabine and Cisplatin as Neoadjuvant Chemotherapy in Patients With High-Grade Upper Tract Urothelial Carcinoma CLE Characteristics of Upper Urinary Tract Urothelial Carcinoma EGCG Modulate the Cytotoxic Effects of Chemotherapeutic Agents in Human Urothelial Carcinoma Cells A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC) Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma Trial of Atezolizumab Plus Chemotherapy After Progression on PD-1 or PD-L1 in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma First-Line Treatment of Advanced Bladder Cancer Randomized vs. Gemcitabine ± Vinflunine in Patients Ineligible to Receive Cisplatin-Based Therapy Gemcitabine and Ifosfamide As a Second-Line Systemic Chemotherapy for Cisplatin -Failed Advanced TCC Weekly TP-HDFL in the Treatment of Advanced TCC Detecting Transitional Cell Carcinoma From Haematuria Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy Phase I/Ib Study of Pembrolizumab With Vorinostat for Patients With Advanced Renal or Urothelial Cell Carcinoma Aristolochic Acid-DNA Adduct in Urothelial Carcinoma in Taiwan Tailored ImmunoTherapy Approach With Nivolumab in Subjects With Metastatic or Advanced Transitional Cell Carcinoma Cabazitaxel vs. Vinflunine in Metastatic or Locally Advanced Transitional Cell Carcinoma of the Urothelium (TCCU) Trial of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma Trebananib (AMG 386) in Combination With Docetaxel for Advanced Urothelial Carcinoma Vasculogenic Mimicry in Urothelial Carcinoma Treatment of Locally Advanced or Metastatic Transitional Cell Carcinoma With Cabazitaxel Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma DNA Methylation and Urothelial Carcinoma JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin DNA Methylation and Arsenic-associated Urothelial Carcinoma Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.

Brief Title

Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract

Official Title

Safety & Efficacy of Neoadjuvant Immunotherapy With Durvalumab (MEDI 4736) Combined With Neoadjuvant Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) in Patients With Operable, High-risk, Localized Urothelial Carcinoma of the Upper Urinary Tract

Brief Summary

      Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients
      face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year
      recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.

      The primary objective of this study is to assess the pathological complete response rate to
      combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin)
      before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of
      the upper tract.
    

Detailed Description

      Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients
      face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year
      recurrence-free and cancer specific survival probabilities of 69% and 73% respectively.
      Additional systemic therapy therefore seems justified for prolonged cancer control. However,
      there have been very few studies on neoadjuvant/adjuvant therapies in UTUC. Recently, the
      UK's multicentric POUT trial reported the benefits of adjuvant chemotherapy in UTUC patients.
      Level 1 evidence has been provided for neoadjuvant therapy for urothelial carcinoma of the
      bladder via meta-analysis in 2005 but there are also several arguments for systemic therapy
      in this context especially as most patients lose the function of one kidney and cannot
      receive nephrotoxic cisplatin-based chemotherapy. Urothelial carcinoma of the upper tract
      have a different genetic background from carcinomas of the lower tract. The investigators
      hypothesized that there would be a greater occurrence of lower pathological stages among
      study group patients who receive neoadjuvant combined Durvalumab/Gemcitabine/Cisplatin or
      Carboplatin prior to RNU compared to the current literature (Gregg et al. 2018, Almassi et
      al. 2018). The primary objective is to assess the pathological complete response rate (ypT0)
      in each cohort and independently of a combination therapy with neoadjuvant durvalumab and
      chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized,
      non-metastatic urothelial carcinomas of the upper tract.Secondary objectives include:
      assessing partial response rate to treatment, assessing the safety and tolerability of the
      treatment and evaluating the overall survival, bladder recurrence and dissemination at two
      years of follow-up.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Pathological complete response in Cohort 1

Secondary Outcome

 Partial pathological response in Cohort 1

Condition

Urothelial Carcinoma

Intervention

Patients receiving neoadjuvant therapy before radical nephrectomy

Study Arms / Comparison Groups

 Durvalumab+Gemcitabine/Cisplatin or with Gemcitabine/Carboplatin
Description:  This is a single arm including 2 different cohorts : Cohort 1 includes patients on 40mg/ML Gemcitabine/50mg Cisplatin used in combination with 50 mg/mL of intravenous Durvalumab (laboratory code MEDI 4736) every 3 weeks for a total of 4 cycles and Cohort 2 includes patients on 40mg/ML Gemcitabine/450mg Carboplatin used in combination with 50 mg/mL of intravenous Durvalumab (laboratory code MEDI 4736) every 3 weeks for a total of 4 cycles..

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

99

Start Date

September 29, 2021

Completion Date

October 1, 2025

Primary Completion Date

January 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Patient has been correctly informed and has given signed consent.

          -  Patient is covered by a health insurance scheme.

          -  Patients aged over 70 must have a G8 score (Soubeyran et al. 2014) of at least 14.

          -  Patient's body weight must be over 30kg

          -  Patient has high-grade urothelial carcinoma of the renal pelvis or ureter confirmed
             histologically (uteroscopic biopsy) or cytologically (urine cytology).

          -  Presence of divergent histologies (i.e. squamous cell tumour, adenocarcinoma, small
             cell carcinoma, micropapillary variant) may also give rise to inclusion if there is a
             high prevalence (over 90%) of a urothelial component.

          -  Presence of EITHER high-grade disease on the uteroscopic tumor biopsy

          -  OR Presence of high-grade disease on urine cytology AND infiltrative aspect of renal
             pelvis/ ureteral wall on the CT scan (presence of hydronephrosis will be considered
             invasive by definition) with negative cystoscopy.

          -  No prior systemic therapies.

          -  ECOG performance status 0 to 1.

          -  M0 No or N1 disease on CT scan.

               -  Required initial laboratory values :

          -  Absolute neutrophil count of over 1500 cells/mm²

          -  Platelet count of over 100,000 cells/mm3

          -  Hemoglobin over 9.0 g/dL

          -  Bilirubin below 1.5 times the Upper Limit of Normal for the institution

          -  Aspartase transaminase (ASAT) and Alanine transaminase (ALAT) below 2.5 x the Upper
             Limit of Normal for the institution.

          -  Alkaline phosphatase below 2.5 times the Upper Limit of Normal for the institution

          -  INR and aPTT below 1.5 times the Upper Limit of Normal for the institution.

          -  For Cohort 1 : An estimated glomerular filtration rate of over 60ml/min/1.73m² using
             the CKD-EPI and/or MDRD equation.

          -  For Cohort 2 : An estimated glomerular filtration rate of 40ml to 60ml/min/1.73m²
             using the CKD-EPI and/or MDRD equation.

          -  Patients with reproductive potential must use an effective method to avoid pregnancy
             for the duration of the trial.

          -  Patients must have a life expectancy of at least 12 weeks.

        Exclusion Criteria:

          -  The patient is participating in another interventional trial;

          -  or is in an exclusion period determined by a previous study;

          -  or is under judicial protection, or is an adult under guardianship

          -  or refuses to sign the consent;

          -  or it is impossible to correctly inform the patient.

          -  The patient is pregnant or breastfeeding.

          -  Concomitant diagnosis of muscle invasive or in situ or high grade non muscle invasive
             urothelial carcinoma of the bladder.

          -  Evidence of NYHA functional class III or IV heart disease.

          -  Serious intercurrent medical or psychiatric illness, including serious active
             infection.

          -  Concomitant use of any other investigational drugs.

          -  Diagnosis of immunodeficiency or received systemic steroid therapy or any other form
             of immunosuppressive therapy within 7 days prior to study registration.

          -  Additional malignancy within last 5 years. Exceptions include basal cell carcinoma of
             the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has
             undergone potentially curative therapy, stable (as defined by PSA change, checked
             within 30 days) and untreated very low-risk or low-risk prostate cancer defined by
             current NCCN guidelines. Previous history of a unique non-muscle invasive bladder
             cancer is acceptable.

          -  Active autoimmune disease requiring systemic treatment within the past 3 months or a
             documented history of clinically severe autoimmune disease, or a syndrome that
             requires systemic steroids or immunosuppressive agents. NOTE: Subjects with vitiligo
             or resolved childhood asthma/atopy would be an exception. Subjects that require
             systemic corticosteroids at physiologic doses not exceed 10mg/day of prednisone or its
             equivalent would not be excluded from the study. Subjects that require intermittent
             use of bronchodilators or local steroid injections would not be excluded from the
             study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's
             syndrome will not be excluded from the study.

          -  History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

          -  Active infection including tuberculosis (clinical evaluation that includes clinical
             history, physical examination and radiographic findings, and TB testing in line with
             local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),
             hepatitis C.

          -  Live vaccine received within 30 days prior to the first dose of trial treatment.

          -  Major surgical procedure (as defined by the Investigator) within 28 days prior to the
             first dose of treatment. Note: Local surgery of isolated lesions for palliative intent
             is acceptable.

          -  History of allogenic organ transplantation.

          -  Uncontrolled intercurrent illness, including but not limited to, on-going or active
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
             angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
             gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social
             situations that would limit compliance with study requirement, substantially increase
             risk of incurring AEs or compromise the ability of the patient to give written
             informed consent

          -  Female patients who are pregnant or breastfeeding or male or female patients of
             reproductive potential who are not willing to employ effective birth control from
             screening to 90 days after the last dose of durvalumab monotherapy.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +33 4 66 68 33 01, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04617756

Organization ID

CIVI/2018/NH-1


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Universitaire de Nīmes

Collaborators

 Pitié-Salpêtrière Hospital

Study Sponsor

, , 


Verification Date

December 2021