Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma
NCT03774901
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Descriptive Information | |||||||||
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Brief Title ICMJE | Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma | ||||||||
Official Title ICMJE | Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma | ||||||||
Brief Summary | Patients with unresectable locally advanced or metastatic squamous cell penile carcinoma (SPC) who are in response or with stable disease after first line platinum containing polychemotherapy who meet the inclusion/exclusion criteria will be offered to take part in the study. The patients may be pre-screened at the time of the 1st line chemotherapy. In order for patients to be enrolled, the investigator must have carried out a radiological assessment of the disease during first line systemic treatment (a maximum of between 3 and 6 cycles): the cancer must be controlled. Patients with disease progression cannot be included in the PULSE study as this is a maintenance study. After inclusion, Avelumab will be administered at a dose of 10 mg/kg, at a frequency of once every 2 weeks with appropriate supportive care. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||
Condition ICMJE |
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Intervention ICMJE | Drug: Avelumab
intravenous 10 mg/kg every 2 weeks | ||||||||
Study Arms ICMJE | Experimental: avelumab maintenance
Avelumab will be administered at a dose of 10 mg/kg every 2 weeks with appropriate supportive care Intervention: Drug: Avelumab | ||||||||
Publications * | Gassian N, Frontczak A, Mouillet G, Vernerey D, Manseur O, Goujon M, Meurisse A, Berthod D, Robert E, Calcagno F, Thiery-Vuillemin A. Activity and tolerability of maintenance avelumab immunotherapy after first line polychemotherapy including platinum in patients with locally advanced or metastatic squamous cell penile carcinoma: PULSE. Bull Cancer. 2020 Jun;107(5S):eS16-eS21. doi: 10.1016/S0007-4551(20)30282-4. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 32 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 1, 2022 | ||||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Key Eligibility Criteria Inclusion:
In the event of pretreatment with cisplatin: a cumulative minimum dose of 210 mg/m2 is required in order to be eligible. In the event of pretreatment with carboplatin: a minimum cumulative dose equivalent to 3 cycles of carboplatin AUC5 is required to be eligible
Absolute neutrophil (N) count ? 1500/mm3 ou ? 1,5.10^9/L Platelets ? 100 000 / mm3 Haemoglobin ? 9 g/dL Creatinine clearance ? 30 mL/min (by the MDRD formula) Total bilirubin ? 1.5 x ULN (upper limit of the normal range) AST ? 2.5 x ULN and ALT ? 2.5 x ULN OR AST and ALT ? 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase Exclusion:
a - Intra-nasal, inhaled or local steroids or local steroid injections (such as intra-articular injections) b - Systemic corticosteroids at physiological doses of ? 10 mg/day of prednisone or equivalent c - Steroids as premedication for hypersensitivity reactions (such as CT scan premedication).
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03774901 | ||||||||
Other Study ID Numbers ICMJE | P/2017/337 2018-001427-38 ( EudraCT Number ) | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Besancon | ||||||||
Collaborators ICMJE | Pfizer | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Centre Hospitalier Universitaire de Besancon | ||||||||
Verification Date | January 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |