Informations générales (source: ClinicalTrials.gov)
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer (TROPHY U-01)
Interventional
Phase 2
Gilead Sciences (Voir sur ClinicalTrials)
août 2018
juin 2030
16 avril 2025
The objective of this study is to evaluate the efficacy and safety of sacituzumab
govitecan-hziy monotherapy and with novel combinations in participants with metastatic
urothelial cancer (mUC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 10/04/2024 12:54:49 | Contacter | ||
| HOPITAL FOCH | PHILIPPE BEUZEBOC | 05/05/2025 07:12:00 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35042 - Rennes Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Departmental (CHD) Vendee - 85925 - La Roche sur Yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Prive Saint-Gregoire - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz - 25000 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional Universitaire Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau - 30029 - Nîmes cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont Ferrand Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69373 - Lyon Cedex 08 - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Andre (CHU de Bordeaux) - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hospitaux Universitaires de Strasbourg - Hopital Civil - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de Lorraine - 54519 - Vandoeuvre les Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13273 - Marseille CEDEX 9 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
Inclusion Criteria for All Cohorts:
- Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
- Adequate renal and hepatic function.
- Adequate hematologic parameters without transfusional support.
- Individuals must have a 3-month life expectancy.
Additional Inclusion Criteria for Cohorts 1 to 6:
- Cohort 1: Have had progression or recurrence of urothelial cancer following receipt
of platinum-containing regimen (cisplatin or carboplatin):
1. Received a first-line platinum-containing regimen in the metastatic setting or
for inoperable locally advanced disease;
2. Or received neo/adjuvant platinum-containing therapy for localized
muscle-invasive urothelial cancer, with recurrence/progression ≤12 months
following completion of therapy.
- Cohort 1: In addition to above criterion, have had progression or recurrence of
urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1
(anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy.
- Cohort 2: Were ineligible for platinum-based therapy for first line metastatic
disease and have had progression or recurrence of urothelial cancer after a
first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual
may not have received any platinum for treatment of recurrent, metastatic or
advanced disease.
- Cohort 3: Progression or recurrence of UC following a platinum containing regimen in
the metastatic setting, or progression or recurrence of UC within 12 months of
completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
- Cohort 4: Individual has not received any platinum-based chemotherapy in the
metastatic or unresectable locally advanced setting. Creatinine clearance of at
least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For
individuals receiving cisplatin at 70 mg/m^2 on Day 1 of every 21-day cycle, a
creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or
another validated tool is required. Individuals with creatinine clearance between 50
to 59 mL/min are to receive a split dose of cisplatin (35 mg/m^2 Day 1 and Day 8 of
every 21-day cycle).
- Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic
urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
- Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM +
cisplatin. No other chemotherapy regimens are allowed in this cohort, with the
exception of prior adjuvant or neoadjuvant systemic therapy with curative intent
after > 12 months from completion of therapy.
- No evidence of progressive disease following completion of first-line chemotherapy
(ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).
- Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
- Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for
unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or >12
months from completion of adjuvant therapy are permitted.
- Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria.
Tumor lesions situated in a previously irradiated area are considered measurable if
progression has been demonstrated in such lesions.
- Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the
Cockcroft-Gault formula unless otherwise specified
Additional Inclusion Criteria for Cohort 7:
- No prior systemic therapy for locally advanced or metastatic UC. Therapy in the
curative setting is allowed provided recurrence is > 12 months since the last dose
of systemic therapy.
- Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma,
or a biopsy of metastatic urothelial carcinoma.
- Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions
situated in a previously irradiated area are considered measurable if progression
has been demonstrated in such lesions.
Key
Inclusion Criteria for All Cohorts:
- Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
- Adequate renal and hepatic function.
- Adequate hematologic parameters without transfusional support.
- Individuals must have a 3-month life expectancy.
Additional Inclusion Criteria for Cohorts 1 to 6:
- Cohort 1: Have had progression or recurrence of urothelial cancer following receipt
of platinum-containing regimen (cisplatin or carboplatin):
1. Received a first-line platinum-containing regimen in the metastatic setting or
for inoperable locally advanced disease;
2. Or received neo/adjuvant platinum-containing therapy for localized
muscle-invasive urothelial cancer, with recurrence/progression ≤12 months
following completion of therapy.
- Cohort 1: In addition to above criterion, have had progression or recurrence of
urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1
(anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy.
- Cohort 2: Were ineligible for platinum-based therapy for first line metastatic
disease and have had progression or recurrence of urothelial cancer after a
first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual
may not have received any platinum for treatment of recurrent, metastatic or
advanced disease.
- Cohort 3: Progression or recurrence of UC following a platinum containing regimen in
the metastatic setting, or progression or recurrence of UC within 12 months of
completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
- Cohort 4: Individual has not received any platinum-based chemotherapy in the
metastatic or unresectable locally advanced setting. Creatinine clearance of at
least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For
individuals receiving cisplatin at 70 mg/m^2 on Day 1 of every 21-day cycle, a
creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or
another validated tool is required. Individuals with creatinine clearance between 50
to 59 mL/min are to receive a split dose of cisplatin (35 mg/m^2 Day 1 and Day 8 of
every 21-day cycle).
- Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic
urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma.
- Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM +
cisplatin. No other chemotherapy regimens are allowed in this cohort, with the
exception of prior adjuvant or neoadjuvant systemic therapy with curative intent
after > 12 months from completion of therapy.
- No evidence of progressive disease following completion of first-line chemotherapy
(ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator).
- Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
- Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for
unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or >12
months from completion of adjuvant therapy are permitted.
- Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria.
Tumor lesions situated in a previously irradiated area are considered measurable if
progression has been demonstrated in such lesions.
- Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the
Cockcroft-Gault formula unless otherwise specified
Additional Inclusion Criteria for Cohort 7:
- No prior systemic therapy for locally advanced or metastatic UC. Therapy in the
curative setting is allowed provided recurrence is > 12 months since the last dose
of systemic therapy.
- Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma,
or a biopsy of metastatic urothelial carcinoma.
- Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions
situated in a previously irradiated area are considered measurable if progression
has been demonstrated in such lesions.
Key
Exclusion Criteria for All cohorts:
- Females who are pregnant or lactating.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events
due to agents administered more than 4 weeks earlier.
- Has an active second malignancy.
- Has known active Hepatitis B or Hepatitis C.
- Has other concurrent medical or psychiatric conditions.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has an active second malignancy.
Additional Exclusion Criteria for Cohorts 1 to 6:
- For Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade <<
2 adverse events not constituting a safety risk based on the investigator's judgment
are acceptable.
- Cohort 3: Has received anti-PD-1/PD-L1 therapy previously.
- Cohorts 3 to 6: Has an active autoimmune disease that required systemic treatment in
past 2 years (ie, with use of disease-modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment.
- Cohorts 3 to 6: Has received a live vaccine within 30 days prior to the first dose
of study drug(s), has history or evidence of interstitial lung disease (ILD) or
non-infectious pneumonitis.
- Cohort 4: Refractory to platinum (i.e., relapsed ≤ 12 months after completion of
chemotherapy) in the neoadjuvant/adjuvant setting.
- Cohorts 4, 5, and 6: For individuals who received prior CPI, a treatment-free
interval >12 months between the last treatment administration and the date of
recurrence is required.
Additional Exclusion Criteria for Cohort 7:
- Have had a prior anticancer therapy within 12 months prior to C1D1 or prior
radiation therapy within 2 weeks prior to C1D1. Individuals participating in
observational studies are eligible. Use of other investigational drugs (drugs not
marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of
first dose of investigational product.
- Have a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan.
- Have a Child-Pugh score of B or C.
- Individuals with uncontrolled diabetes.
- Have active keratitis or corneal ulcerations.
- Participants with ongoing sensory or motor neuropathy Grade ≥ 2.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.