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Urothelial CarcinomaPhase 2TALASURNCT04678362

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

A Phase 2 study testing Talazoparib + Avelumab in people with Urothelial Carcinoma, run by Centre Francois Baclesse at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Talazoparib + Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
14 sitesFrance
Study dates
1 Jun 2021to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 ≥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.
  • Patient must have completed prior to inclusion a platinum-based (cisplatin or carboplatin) polychemotherapy for at least 4 cycles of chemotherapy (until 6 cycles maximum) and have a stable disease or a partial response (PR) or a complete response (CR) from the chemotherapy according to RECIST 1.1 criteria
  • A minimum dose of 55 mg/m² of cisplatin is required in order to count for 1 cycle.
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  • 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:
  • Hemoglobin ≥ 10.0 g/dL (patient may have been transfused before inclusion)
  • 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
  • Patient must have creatinine clearance estimated using the CKD equation of ≥ 40 mL/min
  • Able to swallow and retain oral drug
  • Life expectancy > 12 weeks
  • Serum pregnancy test (for females of childbearing potential) negative at screening
  • Male patient able to father children and female patient of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after the last dose of treatments
  • Patient affiliated to a French Social Security System or a beneficiary of such a system
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
  • Optional: provision of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (or subsection thereof) from the most recent primary or metastatic tumor biopsy

Who cannot join

  • 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 whose disease has progressed according to RECIST v1.1 criteria after the first line platinum-based chemotherapy for urothelial carcinoma. The cancer must not be in the progression phase at inclusion
  • 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
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  • Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patient with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are allowed.Current treatment with an immunosuppressant medicinal product or treatment within 7 days prior to inclusion, EXCEPT:
  • 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
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to inclusion (unless if stable, asymptomatic and treated with a low molecular heparin for at least 10 days prior to starting Talazoparib + Avelumab).
  • Pregnant or lactating woman;
  • Participation in another interventional study with a systemic anti-cancer treatment within 4 weeks prior to inclusion. Inclusion in observational or interventional studies not involving a health product is permitted. Patient with telephone follow up of toxicities and simple laboratory monitoring or other questionnaires alone may be included.
  • Patient unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication;Previous organ transplant including stem cell allotransplantation or double umbilical cord blood transplantation.
  • Patient with a known hypersensitivity to Talazoparib and Avelumab or any of the excipients of the product.
  • People who are vulnerable under the law (minors, adults under legal protection, people deprived of their freedom)
  • Other persisting toxicities related to previous anticancer treatments: "Persisting toxicity related to prior therapy (NCI CTCAE Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable."

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

14 sites in 1 country

France14 sites, 12 recruiting

  • Institut de Cancérologie de l'Ouest

    Angers

    Elouen BOUGHALEM, MD, +33 2 41 35 28 92, elouen.boughalem@ico.unicancer.fr

    Elouen BOUGHALEM, MD

    Recruiting

  • CHU Jean Minjoz

    Besançon

    Thiery VUILLEMIN, MD, +33370632403, a.thieryvuillemin@mac.com

    Thiery VUILLEMIN, MD

    Recruiting

  • Centre François baclesse

    Caen, 14000

    Active, not recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Hakim MAHAMMEDI, MD, +33473278080, hakim.mahammedi@clermont.unicancer.fr

    Hakim MAHAMMEDI, MD

    Recruiting

  • Centre George-François Leclerc

    Dijon

    Sylvain LADOIRE, MD, +33380737500, sladoire@cgfl.fr

    Sylvain LADOIRE, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Aude FLECHON, MD, +33478782643, aude.flechon@lyon.unicancer.fr

    Aude FLECHON, MD

    Recruiting

  • Hospices civils de Lyon

    Lyon

    Active, not recruiting

  • Institut Paoli Calmettes

    Marseille

    Gwenaelle GRAVIS, MD, +33491223740, gravisc@ipc.unicancer.fr

    Gwenaelle GRAVIS, MD

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest

    Nantes

    Elouen BOUGHALEM, MD, +33240679900, elouen.boughalem@ico.unicancer.fr

    Elouen BOUGHALEM, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Delphine BORCHIELLINI, MD, +33492031514, delphine.borchiellini@nice.unicancer.fr

    Delphine BORCHIELLINI, MD

    Recruiting

  • Croix Saint-Simon Diaconesses

    Paris

    Camille SERRATE, MD, +33144741008, cserrate@hopital-dcss.org

    Camille SERRATE, MD

    Recruiting

  • Hopital Tenon

    Paris

    Ahmed KHALIL, MD, +33156017576, ahmed.khalil@aphp.fr

    Ahmed KHALIL, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Laurence CROUZET, MD, +332 99 25 44 11, l.crouzet@rennes.unicancer.fr

    Laurence CROUZET, MD

    Recruiting

  • IUCT

    Toulouse

    Damien POUESSEL, MD, +33531155993, pouessel.damien@iuct-oncopole.fr

    Damien POUESSEL, MD

    Recruiting

Other trials in France

About this study

Official title: TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma: A Single-arm Phase 2 Trial

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.

Read the detailed description

The first line treatment of urothelial carcinoma is a platinum-based chemotherapy. This treatment is efficient with a response rate > 50 % but the progression-free survival is short (7.7 months) and the chemotherapy is too toxic to be used in a prolonged time. Traditionally, maintenance chemotherapy refers to the utilization of regimens with less toxicity after the initial upfront treatment. This concept has already been efficient with PARP inhibitors in ovarian carcinoma and more recently with durvalumab in lung carcinoma.

The prevalence of somatic mutations in homologous recombination genes in UC as well as their association with platinum sensitivity suggests Talazoparib to be a target for a maintenance treatment of urothelial carcinoma. Moreover, there is a strong rational with both pre-clinical and clinical data to associate Avelumab and Talazoparib. This appears all the more relevant that Avelumab has already demonstrated its efficacy in urothelial carcinoma (after platinum-based chemotherapy failure).

In this context, the sponsorpropose a phase 2 study to assess the antitumor activity of the combination of Avelumab plus Talazoparib in metastatic urothelial carcinoma in maintenance therapy after platinum-based chemotherapy.

Considering the doubts about the best molecular predictive factors of Talazoparib and Avelumab, the sponsor willingly propose a non-selective study, without molecular screening. Tumors will be selected according to the platinum sensitivity which has the advantage to exclude poor prognosis tumors and will allow increasing the HRD tumor population.

Being tested
Talazoparib + Avelumab
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • Talazoparib + AvelumabDrug

    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.

Study groups in NCT04678362
Study groupRoleWhat they receive
Talazoparib+avelumabExperimental* 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.
Receives: Drug: Talazoparib + Avelumab

What is being measured

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

  1. The progression-free survival

    Measured: 7 months

Secondary outcomes (2)

  1. Overall Survival

    Measured: 18 months

  2. Duration of tumoral response

    Measured: 18 months

Timeline

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

  1. First posted21 Dec 2020
  2. Study start1 Jun 2021
  3. Primary completion28 Jul 2023
  4. Study completionDec 2025 (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
Single-arm phase 2 trial
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678362
Sponsor's protocol ID
2020-001105-24
Acronym
TALASUR
Status last verified
Aug 2025
First submitted
16 Dec 2020
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36434554

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talazoparib + Avelumab in people with Urothelial Carcinoma, run by Centre Francois Baclesse at 14 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 25 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The progression-free survival (time frame: 7 months). 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 NCT04678362, which also lists 1 linked publication.

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 22 Sep 2025.

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