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New treatment option for Urothelial Carcinoma
Official title TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma
ClinicalTrials.gov ID: NCT04678362
What this study is testing
What is Talazoparib + Avelumab?
Talazoparib + Avelumab is an investigational medicine, being studied as a potential treatment for urothelial carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Patient must have completed prior to inclusion a platinum-based (cisplatin or carboplatin) polychemotherapy for at least 4 cycles of chemotherapy...
You likely can't join 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 whose disease has progressed according to RECIST v1.1 criteria after the first line platinum-based chemotherapy for urothelial carcinoma. The...
- 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...
- Patient with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML
See the full eligibility criteria
Who can 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...
- 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...
- 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:
- 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...
- 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...
- 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
What rules you out
- 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...
- Patient with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML
- 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...
- 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...
- 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 \>...
- 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 (≥...
- 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...
- 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 treatment study with a systemic anti-cancer treatment within 4 weeks prior to inclusion. Inclusion in observational or treatment studies not involving a health product is permitted. Patient with...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Besançon, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Lyon, France
- Marseille, France
- Nantes, France
- Nice, France
- Paris, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Besançon, France; Caen, France; Clermont-Ferrand, France; Dijon, France; Lyon, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.