Actively Recruiting
TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma
Led by Centre Francois Baclesse · Updated on 2025-09-22
50
Participants Needed
14
Research Sites
234 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.
CONDITIONS
Official Title
TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older at the time of consenting
- Signed informed consent provided before any study procedures
- Histologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, with transitional cell carcinoma as the predominant histology if mixed
- Documented Stage IV disease not eligible for curative surgery or radiotherapy at start of first-line platinum-based chemotherapy
- Completed 4 to 6 cycles of cisplatin or carboplatin-based chemotherapy with stable disease, partial response, or complete response according to RECIST 1.1
- Minimum cisplatin dose of 55 mg/m2 or carboplatin AUC 4.5 per cycle
- Neoadjuvant or adjuvant chemotherapy allowed if relapse occurs at least 12 months after last dose
- Enrolled within 8 weeks after last chemotherapy dose and starting study treatment at least 3 weeks after last chemotherapy
- ECOG performance status 0 to 2
- Normal organ and bone marrow function within 28 days prior to study treatment
- Hemoglobin ≥ 10.0 g/dL
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 G/l
- Total bilirubin ≤ 1.5 times institutional upper limit of normal
- AST/ALT ≤ 2.5 times upper limit of normal or ≤ 5 times if liver metastases present
- Creatinine clearance ≥ 40 mL/min
- Able to swallow and retain oral medication
- Life expectancy greater than 12 weeks
- Negative pregnancy test for females of childbearing potential
- Use of two highly effective contraception methods during the study and for at least 60 days after last treatment dose for males able to father children and females at risk of pregnancy
- Affiliated with French Social Security or beneficiary
- Willing and able to comply with study protocol and visits
- Optional provision of recent tumor tissue block
You will not qualify if you...
- No prior chemotherapy with a platinum salt for advanced/metastatic urothelial carcinoma
- More than one prior line of chemotherapy for advanced/metastatic urothelial carcinoma
- Disease progression after first-line platinum-based chemotherapy according to RECIST v1.1
- Known central nervous system metastases or carcinomatous meningitis
- Other malignancy within last 3 years except certain treated skin, cervical, or prostate cancers
- History or features suggestive of myelodysplastic syndrome or acute myeloid leukemia
- Active autoimmune disease likely to worsen with immunostimulatory agents except some controlled conditions
- Use of immunosuppressants within 7 days before inclusion except specific allowed steroids
- Major surgery within 4 weeks or major radiotherapy before starting treatment, except limited palliative radiotherapy
- Active viral infections or positive HIV history
- Prior treatment with PARP inhibitors or immunotherapy
- Use of prohibited medications including live vaccines or strong P-gp inhibitors
- Significant cardiovascular disease or recent stroke
- Serious uncontrolled medical disorders or infections
- Recent pulmonary embolism or deep vein thrombosis unless stable and treated
- Pregnant or breastfeeding women
- Participation in other systemic anti-cancer interventional studies within 4 weeks
- Unable to swallow oral medication or gastrointestinal disorders affecting absorption
- Previous organ transplant including stem cell or umbilical cord transplantation
- Known allergy to Talazoparib, Avelumab, or excipients
- Vulnerable populations under law
- Persisting toxicities from previous anticancer treatments above specified grades except some manageable conditions
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Institut de Cancérologie de l'Ouest
Angers, France
Actively Recruiting
2
CHU Jean Minjoz
Besançon, France
Actively Recruiting
3
Centre François baclesse
Caen, France, 14000
Active, Not Recruiting
4
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
5
Centre George-François Leclerc
Dijon, France
Actively Recruiting
6
Centre Léon Bérard
Lyon, France
Actively Recruiting
7
Hospices civils de Lyon
Lyon, France
Active, Not Recruiting
8
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
9
Institut de Cancérologie de l'Ouest
Nantes, France
Actively Recruiting
10
Centre Antoine Lacassagne
Nice, France
Actively Recruiting
11
Croix Saint-Simon Diaconesses
Paris, France
Actively Recruiting
12
Hopital Tenon
Paris, France
Actively Recruiting
13
Centre Eugène Marquis
Rennes, France
Actively Recruiting
14
IUCT
Toulouse, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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