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Urothelial CarcinomaPhase 2iNDUCTNCT04617756

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

A Phase 2 study testing Patients receiving neoadjuvant therapy before radical nephrectomy in people with Urothelial Carcinoma and Cancer, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma, Cancer
What is being tested?
Patients receiving neoadjuvant therapy before radical nephrectomy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesFrance
Study dates
29 Sep 2021to 1 Oct 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Or in the absence of histological evidence, the opinion of the multidisciplinary consultation meeting (RCP) will prevail for the analysis of the imaging and the potential inclusion of the patient in the study
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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 or concomitant history of 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.

Trial locations and contacts

9 sites in 1 country.

Nadine HOUEDE, Pr. contact

+33 4 66 68 33 01

nadine.HOUEDE@chu-nimes.fr

Annissa MEZGARI contact

+33 4 66 68 30 52

drc@chu-nimes.fr

9 sites in 1 country

France9 sites, 9 recruiting

  • Institut Paoli Calmette

    Marseille, 13009

    Gwénaëlle Gravis, gravisg@ipc.unicancer.fr

    Recruiting

  • Hôpital Bichat-Claude Bernard

    Paris, Paris Cx 20, 75018

    Evanguelos XYLINAS, evanguelosxylinas@aphp.fr

    Recruiting

  • Hôpital Saint Louis

    Paris, 75010

    Alexandra Masson-Lecomte, alexandra.massonlecomte@aphp.fr

    Recruiting

  • Hôpital Pitié Salpétrière

    Paris, 75013 Paris

    Morgan ROUPRET, PUPH, 01 42 17 72 97, mroupret@gmail.com

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris, 75015

    François Audenet, francois.audenet@gmail.com

    Recruiting

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69310

    Sophie TARTAS, Sophie.tartas@chu-lyon.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Brigitte LAGUERRE, 0299253182, b.laguerre@rennes.unicancer.fr

    Recruiting

  • Hôpital Foch

    Suresnes, 92151

    Yann Neuzillet, y.neuzillet@hopital-foch.org

    Recruiting

  • Iuct Oncopole

    Toulouse, 31059

    Damien POUESSEL, pouessel.damien@iuct-oncopole.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Patients receiving neoadjuvant therapy before radical nephrectomy
Keywords
Durvalumab, Gemcitabine, Cisplatin, Chemotherapy
Medical subject headings
Carcinoma, Transitional Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients receiving neoadjuvant therapy before radical nephrectomyDrug

    Chemotherapy using either a combination of Gemcitabine/Cisplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736) or Chemotherapy with either Gemcitibine/Carboplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736)

Study groups in NCT04617756
Study groupRoleWhat they receive
Durvalumab+Gemcitabine/Cisplatin or with Gemcitabine/CarboplatinExperimentalThis 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..
Receives: Drug: Patients receiving neoadjuvant therapy before radical nephrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response in Cohort 1

    For Cohort 1 (patients on treatment combining Durvalumab and Gemcitabine associated with Cisplatin) the rate of patients with pathological complete response will be calculated and presented with associated 95% confidence interval on the subpopulation of patients with ureteroscopic biopsy at diagnosis.Pathological complete response is defined as no residual signs of viable tumor cells in tissue samples removed during surgery after treatment. To find out if there is a pathologic complete response, a pathologist will perform an evaluation of the tissue samples under a microscope to see if there are still cancer cells left after the treatment.

    Measured: Week 14 - 18

  2. Pathological complete response in Cohort 2

    For Cohort 2 (patients on treatment combining Durvalumab and Gemcitabine associated with Carboplatin) the rate of patients with pathological complete response will be calculated and presented with associated 95% confidence interval on the subpopulation of patients with ureteroscopic biopsy at diagnosis.Pathological complete response is defined as no residual signs of viable tumor cells in tissue samples removed during surgery after treatment. To find out if there is a pathologic complete response, a pathologist will perform an evaluation of the tissue samples under a microscope to see if there are still cancer cells left after the treatment.

    Measured: Week 14 - 18

Secondary outcomes (90)

  1. Partial pathological response in Cohort 1

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 3

  2. Partial pathological response in Cohort 2

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 3

  3. Partial pathological response in Cohort 1

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 6

  4. Partial pathological response in Cohort 2

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 6

  5. Partial pathological response in Cohort 1

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 9

  6. Partial pathological response in Cohort 2

    Pathological partial response is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease).The rate of patients with partial pathological response will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.

    Measured: Week 9

  7. Safety and tolerability of treatment - Cohort 1

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 3

  8. Safety and tolerability of treatment - Cohort 2

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 3

  9. Safety and tolerability of treatment - Cohort 1

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 6

  10. Safety and tolerability of treatment - Cohort 2

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 6

  11. Safety and tolerability of treatment - Cohort 1

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 9

  12. Safety and tolerability of treatment - Cohort 2

    The safety and tolerability of treatment will be assessed by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).

    Measured: Week 9

  13. Treatment success - Overall Survival in Cohort 1

    The overall Survival rate of Cohort 1 patients will be collected.

    Measured: 2 years after surgery.

  14. Treatment success - bladder recurrence and dissemination in Cohort 1

    Bladder recurrence and dissemination in Cohort 1 patients will be collected.

    Measured: 2 years after surgery.

  15. Treatment success - Overall Survival in Cohort 2

    The overall Survival rate of Cohort 2 patients will be collected.

    Measured: 2 years after surgery.

  16. Treatment success - bladder recurrence and dissemination in Cohort 2

    Bladder recurrence and dissemination will be collected.

    Measured: 2 years after surgery.

  17. Intercycle report : Blood cells & Platelets in Cohort 1

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 3

  18. Intercycle report : Blood cells & Platelets in Cohort 2

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 3

  19. Intercycle report : Electrolytes in Cohort 1

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 3

  20. Intercycle report : Electrolytes in Cohort 2

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 3

  21. Intercycle report : Liver in Cohort 1 - AST

    • Hepatic workup: Aspartate Aminotransferase (AST) concentration will be measured in IU/L.

    Measured: Week 3

  22. Intercycle report : Liver in Cohort 1 - ALT

    • Hepatic workup: Alanine Aminotransferase (ALT) concentration will be measured in IU/L.

    Measured: Week 3

  23. Intercycle report : Liver in Cohort 1 -GGT

    • Hepatic workup: Gamma-Glutamyl Transferase (GGT) concentration will be measured in IU/L.

    Measured: Week 3

  24. Intercycle report : Liver in Cohort 1 - LDH

    • Hepatic workup: Lactate Dehydrogenase (LDH) concentration will be measured in IU/L.

    Measured: Week 3

  25. Intercycle report : Liver in Cohort 1 - ALP

    • Hepatic workup: Alkaline Phosphatase (ALP) concentration will be measured in IU/L.

    Measured: Week 3

  26. Intercycle report : Liver in Cohort 1 - bilirubin

    • Hepatic workup: Bilirubin (free/conjugated) concentration will be measured il micromoles/L

    Measured: Week 3

  27. Intercycle report : Liver in Cohort 2 - AST

    • Hepatic workup: Aspartate Aminotransferase (AST) concentration will be measured in IU/L.

    Measured: Week 3

  28. Intercycle report : Liver in Cohort 2 - ALT

    • Hepatic workup: Alanine Aminotransferase (ALT) concentration will be measured in IU/L.

    Measured: Week 3

  29. Intercycle report : Liver in Cohort 2 - GGT

    • Hepatic workup: Gamma-Glutamyl Transferase (GGT) concentration will be measured in IU/L.

    Measured: Week 3

  30. Intercycle report : Liver in Cohort 2 - LDH

    • Hepatic workup: Lactate Dehydrogenase (LDH) concentration will be measured in IU/L.

    Measured: Week 3

  31. Intercycle report : Liver in Cohort 2 - ALP

    • Hepatic workup: Alkaline Phosphatase (ALP) concentration will be measured in IU/L.

    Measured: Week 3

  32. Intercycle report : Liver in Cohort 2 - bilirubin

    • Hepatic workup: bilirubin (free/conjugated) concentration will be measured in micromoles/L.

    Measured: Week 3

  33. Intercycle report : Creatinine Phosphokinase in Cohort 1

    Creatine Phosphokinase will be measured in IU/L. usually between 60 and 400 IU/L

    Measured: Week 3

  34. Intercycle report : Creatinine Phosphokinase in Cohort 2

    Creatine Phosphokinase will be measured in IU/L. usually between 60 and 400 IU/L

    Measured: Week 3

  35. Intercycle report : Thyroid in Cohort 1

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 3

  36. Intercycle report : Thyroid in Cohort 2

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 3

  37. Intercycle report : Cortisol in Cohort 1

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 3

  38. Intercycle report : Cortisol in Cohort 2

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 3

  39. Intercycle report : C-reactive protein in Cohort 1

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 3

  40. Intercycle report : C-reactive protein in Cohort 2

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 3

  41. Intercycle report : Urine in Cohort 1

    Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows:

    (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 3

  42. Intercycle report : Urine in Cohort 2

    Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows:

    (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 3

  43. Intercycle report: N-BNP, troponin in Cohort 1

    Serum N-BNP and troponin concentrations will be measured. These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 3

  44. Intercycle report: N-BNP, troponin in Cohort 2

    Serum N-BNP and troponin concentrations will be measured.These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 3

  45. Intercycle report: Blood cells & platelets in Cohort 1

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 6

  46. Intercycle report: Blood cells & Platelets in Cohort 2

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 6

  47. Intercycle report: Electrolytes in Cohort 1

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 6

  48. Intercycle report : Electrolytes in Cohort 2

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 6

  49. Intercycle report : Liver in Cohort 1 - AST

    Hepatic workup: Aspartate Aminotransferase (AST) concentration will be measured in IU/L..

    Measured: Week 6

  50. Intercycle report : Liver in Cohort 1 - ALT

    Hepatic workup: Aminotransferase (ALT) concentration will be measured in IU/L.

    Measured: Week 6

  51. Intercycle report : Liver in Cohort 1 - GGT

    Hepatic workup: Gamma-Glutamyl Transferase (GGT) concentrations will be measured in IU/L.

    Measured: Week 6

  52. Intercycle report : Liver in Cohort 1 - LDH

    Hepatic workup: Lactate Dehydrogenase (LDH) concentration will be measured in IU/L.

    Measured: Week 6

  53. Intercycle report : Liver in Cohort 1 - ALP

    Hepatic workup: Alkaline Phosphatase (ALP) concentration will be measured in IU/L.

    Measured: Week 6

  54. Intercycle report : Liver in Cohort 1 - bilirubin

    Hepatic workup: Bilirubin (free/conjugated) concentration will be measured in micromoles/L

    Measured: Week 6

  55. Intercycle report : Liver in Cohort 2 - AST

    • Hepatic workup: Aspartate Aminotransferase (AST) concentration will be measured.

    Measured: Week 6

  56. Intercycle report : Liver in Cohort 2 - ALT

    • Hepatic workup: Alanine Aminotransferase (ALT) concentration will be measured in IU/L.

    Measured: Week 6

  57. Intercycle report : Liver in Cohort 2 - GGT

    • Hepatic workup: Gamma-Glutamyl Transferase (GGT) concentration will be measured in IU/L.

    Measured: Week 6

  58. Intercycle report : Liver in Cohort 2 - LDH

    • Hepatic workup: Lactate Dehydrogenase (LDH) concentration will be measured in IU/L.

    Measured: Week 6

  59. Intercycle report : Liver in Cohort 2 - ALP

    • Hepatic workup: Alkaline Phosphatase (ALP) concentration will be measured in IU/L.

    Measured: Week 6

  60. Intercycle report : Liver in Cohort 2 - bilirubin

    • Hepatic workup: Bilirubin (free/conjugated) concentration will be measured in micromoles/L.

    Measured: Week 6

  61. Intercycle report : Creatine Phosphokinase in Cohort 1

    • Creatine Phosphokinase will be measured in IU/L. Normal values are usually between 60 and 400 IU/L

    Measured: Week 6

  62. Intercycle report : Creatine Phosphokinase in Cohort 2

    • Creatine Phosphokinase will be measured in IU/L. usually between 60 and 400 IU/L

    Measured: Week 6

  63. Intercycle report : Thyroid in Cohort 1

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 6

  64. Intercycle report : Thyroid in Cohort 2

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 6

  65. Intercycle report : Cortisol in Cohort 1

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 6

  66. Intercycle report : Cortisol in Cohort 2

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 6

  67. Intercycle report : C-reactive protein in Cohort 1

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 6

  68. Intercycle report : C-reactive protein in Cohort 2

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 6

  69. Intercycle report : Urine in Cohort 1

    Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows:

    (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 6

  70. Intercycle report : Urine in Cohort 2

    • Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows: (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 6

  71. Intercycle report : N-BNP, troponin in Cohort 1

    Serum N-BNP and troponin concentrations will be measured.These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 6

  72. Intercycle report : N-BNP, troponin in Cohort 2

    Serum N-BNP and troponin concentrations will be measured.These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 6

  73. Intercycle report: Blood cells & Platelets in Cohort 1

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 9

  74. Intercycle report: Blood cells & Platelets in Cohort 2

    The numbers of each type of blood cell and platelets will be measured per McL

    Measured: Week 9

  75. Intercycle report: Electrolytes in Cohort 1

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 9

  76. Intercycle report: Electrolytes in Cohort 2

    A basic metabolic panel will be run to measure Na, K, Cl and Protein levels.

    Measured: Week 9

  77. Intercycle report: Liver in Cohort 1

    • Hepatic workup: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP) and bilirubin (free/conjugated) concentrations will all be measured.

    Measured: Week 9

  78. Intercycle report: Liver in Cohort 2

    • Hepatic workup: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP) and bilirubin (free/conjugated) concentrations will all be measured.

    Measured: Week 9

  79. Intercycle report: Creatine Phosphokinase in Cohort 1

    Creatine Phosphokinase Creatine Phosphokinase will be measured in IU/L. usually between 60 and 400 IU/L

    Measured: Week 9

  80. Intercycle report: Creatine Phosphokinase in Cohort 2

    Creatine Phosphokinase will be measured in IU/L. usually between 60 and 400 IU/L

    Measured: Week 9

  81. Intercycle report: Thyroid in Cohort 1

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 9

  82. Intercycle report: Thyroid in Cohort 2

    A thyroid stimulating test (total T4 test) will be made to measure the thyroxine concentration in the patient's blood.

    Measured: Week 9

  83. Intercycle report: Cortisol in Cohort 1

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 9

  84. Intercycle report: Cortisol in Cohort 2

    Cortisol (serum) levels will be measured at 8 a.m. only (i.e. one cycle out of two) to check whether the adrenal glands are functioning correctly. Normal levels for adults in the morning are :

    5-25 mcg/dL (138-690 nmol/L) or 5-23 mcg/dL (138-635 nmol/L) for elderly patients.

    Measured: Week 9

  85. Intercycle report: C-reactive protein in Cohort 1

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 9

  86. Intercycle report: C-reactive protein in Cohort 2

    C-reactive protein will be measured in mg/L. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L).

    Measured: Week 9

  87. Intercycle report : Urine in Cohort 1

    Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows:

    (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 9

  88. Intercycle report: Urine in Cohort 2

    Urinary balance: via a cytobacteriological examination, the protein/creatinine ratio will be calculated as follows:

    (Urine protein(g/L) X 1000)/Urine creatinine(mmol/L)

    Measured: Week 9

  89. Intercycle report: N-BNP, troponin in Cohort 1

    Serum N-BNP and troponin concentrations will be measured. These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 9

  90. Intercycle report: N-BNP, troponin in Cohort 2

    Serum N-BNP and troponin concentrations will be measured. These are biomarkers of heart failure. N-BNP is measured in pg/mL and troponin is measured in ng/mL.

    Measured: Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start29 Sep 2021
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients with an estimated glomerular filtration rate equal to or over 60 ml/min./1.73² (cohort 1) will receive treatment combining Durvalumab and gemcitabine with Cisplatin. Patients with an estimated glomerular filtration rate of under 60 ml/min./1.73² and over 40 ml/min./1.73² (cohort 2) will receive treatment combining Durvalumab and gemcitabine with Carboplatin.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04617756
Sponsor's protocol ID
CIVI/2018/NH-1
Acronym
iNDUCT
Status last verified
May 2023
First submitted
28 Oct 2020
Last updated
30 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Houede N, Chevallier T, Audenet F, Thibault C, Neuzillet Y, Abraham C, Masson-Lecomte A, Gauthier H, Gravis G, Pignot G, Tartas S, Ruffion A, Pouessel D, Roumiguie M, Laguerre B, Bensalah K, Xylinas E, Jaffrelot L, Droupy S, Luquiens G, Roupret M. Safety and Efficacy of Neoadjuvant Durvalumab Plus Gemcitabine/Cisplatin or Carboplatin in Patients With Operable High-Risk Upper Tract Urothelial Carcinoma: The iNDUCT-GETUG V08 Trial. J Clin Oncol. 2025 May;43(13):1578-1586. doi: 10.1200/JCO-25-00179. Epub 2025 Feb 14.

    PubMed 39951246

  • Calleris G, Roupret M, Seisen T, Bendjeddou L, Chevallier T, Masson-Lecomte A, Thibault C, Neuzillet Y, Audenet F, Xylinas E, Houede N. Design and rationale of a single-arm phase II study of neoadjuvant Durvalumab and Gemcitabine associated with Cisplatin or Carboplatin for upper urinary tract urothelial cancer: the iNDUCT trial (NCT04617756). World J Urol. 2023 Dec;41(12):3413-3420. doi: 10.1007/s00345-023-04596-5. Epub 2023 Sep 12.

    PubMed 37698632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patients receiving neoadjuvant therapy before radical nephrectomy in people with Urothelial Carcinoma and Cancer, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nadine HOUEDE, Pr. (+33 4 66 68 33 01, nadine.HOUEDE@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response in Cohort 1 (time frame: Week 14 - 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04617756, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.

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