TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma

NCT04678362 | Recruiting Phase 2

• 1 other identifier: 2020-001105-24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 14

Brief Summary

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

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• The progression-free survival

  7 months

Secondary Outcomes (2)

• Overall Survival

  18 months

• Duration of tumoral response

  18 months

Study Arms (1)

Talazoparib+avelumab

EXPERIMENTAL

* Talazoparib will be administered at the daily dose of 1 mg given orally in a 28-day cycle, except for patients with mild renal impairment (Creatinine clearance 30-59 mL/min) who will receive 0.75 mg per day. * Avelumab will be administered by intravenous (I.V.) route over 60 minutes at the dose of 800 mg on D1 and D15, in a 28-day cycle.

Drug: Talazoparib + Avelumab

Interventions

Talazoparib + Avelumab DRUG

Patients will receive the combined treatment until the investigator considers that the patient no longer obtains benefit from it. The treatment will be continued until disease progression, unacceptable toxicity or discontinuation for any cause.

Talazoparib+avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥18 years at the day of consenting to the study
• Provision of informed consent prior to any study specific procedures
• Histologically confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter (upper urinary tract), bladder or urethra. Both transitional cell and mixed transitional/non-transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
• Documented Stage IV disease (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1) not candidate to a curative treatment with surgery or radiotherapy at the start of first-line platinum-based chemotherapy.
• A minimum dose of 55 mg/m² of cisplatin is required in order to count for 1 cycle.
• A minimum dose of carboplatin AUC 4.5 is required in order to count for 1 cycle
• Eligibility based on this criterion will be established locally by the investigator by examining pre and post-chemotherapy radiological assessments (CT/MRI)
• Neoadjuvant or adjuvant chemotherapy is allowed (with a delay of at least 12 months between the last dose of neoadjuvant or adjuvant chemotherapy and the relapse)
• Patient must be enrolled within 8 weeks after the last dose of chemotherapy and should start study treatment at least 3 weeks after the last dose of chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelet count ≥100 G/l
• Total bilirubin ≤1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x ULN unless liver metastases are present in which case they must be ≤5x ULN

You may not qualify if:

• Patient who has never received chemotherapy with a platinum salt (cisplatin or carboplatin) for advanced/metastatic urothelial carcinoma
• Patient who has previously received more than one line of chemotherapy for advanced/metastatic urothelial carcinoma
• Patient with known CNS metastases and/or carcinomatous meningitis
• Other malignancy within the last 3 years except: adequately treated non-melanoma, skin cancer curatively treated, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), localized prostate carcinoma without PSA relapse
• Patient with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML
• Intra-nasal, inhaled or local steroids or local steroid injections (such as intra-articular injections)
• Systemic corticosteroids at physiological doses of ≤ 10 mg/day of prednisone or equivalent
• Steroids as premedication for hypersensitivity reactions (such as CT scan premedication)
• Major surgery within 4 weeks or major radiotherapy within to starting experimental treatment. Previous palliative radiotherapy (≤ 10 fractions) for metastatic lesions is permitted provided that this has been completed at least one week prior to starting Talazoparib and Avelumab
• Active viral infection (HIV, Hepatitis B/C) or known history of positive test for HIV
• Any previous treatment with PARP inhibitor or any immunotherapy (e.g. anti-CTLA-4 or anti-PDL1/ PD1)
• Concomitant treatment with any drug on the prohibited medication list such as live vaccines, concomitant use of strong P-gp inhibitors (cf section "Prohibited concomitant treatments") or systemic corticoids at dose \> 10 mg/day prednisone or equivalent. Live vaccines administered more than 30 days before study entry are permitted
• Clinically significant (e.g. active) cardiovascular disease cerebral vascular accident/stroke in the 3 months prior to enrollment: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (≥ New York Heart Association Classification Class II), serious cardiac arrhythmia requiring medication, uncontrolled high blood pressure, cerebrovascular accident, transient ischaemic attack
• Patient considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibits obtaining informed consent
• Pregnant or lactating woman;

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• Pfizer: collaborator

Study Sites (14)

Institut de Cancérologie de l'Ouest

Angers, France

RECRUITING

CHU Jean Minjoz

Besançon, France

RECRUITING

Centre François baclesse

Caen, 14000, France

ACTIVE NOT RECRUITING

Centre Jean Perrin

Clermont-Ferrand, France

RECRUITING

Centre George-François Leclerc

Dijon, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hospices civils de Lyon

Lyon, France

ACTIVE NOT RECRUITING

Institut Paoli Calmettes

Marseille, France

NOT YET RECRUITING

Institut de Cancérologie de l'Ouest

Nantes, France

RECRUITING

Centre Antoine Lacassagne

Nice, France

RECRUITING

Croix Saint-Simon Diaconesses

Paris, France

RECRUITING

Hopital Tenon

Paris, France

RECRUITING

Centre Eugène Marquis

Rennes, France

RECRUITING

IUCT

Toulouse, France

RECRUITING

Related Publications (1)

• Coquan E, Clarisse B, Lequesne J, Brachet PE, Neviere Z, Meriaux E, Bonnet I, Castera M, Goardon N, Boutrois J, Travers R, Joly F, Grellard JM, Thiery-Vuillemin A. TALASUR trial: a single arm phase II trial assessing efficacy and safety of TALazoparib and Avelumab as maintenance therapy in platinum-Sensitive metastatic or locally advanced URothelial carcinoma. BMC Cancer. 2022 Nov 24;22(1):1213. doi: 10.1186/s12885-022-10216-z.

  PMID: 36434554 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

talazoparib; avelumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None (open label=)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm phase 2 trial

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: June 1, 2021
• Primary Completion: July 28, 2023
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)