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.
Condition or disease | Intervention/treatment | Phase |
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Penile Cancer Penile Neoplasms Penile Squamous Cell Carcinoma | Drug: Avelumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma |
Actual Study Start Date : | March 12, 2019 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | February 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: avelumab maintenance
Avelumab will be administered at a dose of 10 mg/kg every 2 weeks with appropriate supportive care
|
Drug: Avelumab
intravenous 10 mg/kg every 2 weeks
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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).
Contact: Elise Robert | 0033381219086 | e1robert@chu-besancon.fr | |
Contact: Diane Berthod | 0033370632403 | dberthod@chu-besancon.fr |
France | |
Antoine THIERY VUILLEMIN | Recruiting |
Besançon, France, 25000 | |
Contact: Antoine THIERY-VUILLEMIN, MD |
Tracking Information | |||||||||
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First Submitted Date ICMJE | November 29, 2018 | ||||||||
First Posted Date ICMJE | December 13, 2018 | ||||||||
Last Update Posted Date | February 1, 2021 | ||||||||
Actual Study Start Date ICMJE | March 12, 2019 | ||||||||
Estimated Primary Completion Date | February 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
PFS (progression-free survival) [ Time Frame: 24 months ] To estimate progression-free survival in patients included in this study
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
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. |
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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 |
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Condition ICMJE |
|
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Intervention ICMJE | Drug: Avelumab
intravenous 10 mg/kg every 2 weeks
|
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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
|
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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. |
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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 ) |
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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 |