Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma (PULSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03774901|
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 24, 2019
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|
|Penile Cancer Penile Neoplasms Penile Squamous Cell Carcinoma||Drug: Avelumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: avelumab maintenance
Avelumab will be administered at a dose of 10 mg/kg every 2 weeks with appropriate supportive care
intravenous 10 mg/kg every 2 weeks
- PFS (progression-free survival) [ Time Frame: 24 months ]To estimate progression-free survival in patients included in this study
- OS (overall survival) [ Time Frame: 32 months ]To estimate overall survival in patients included in this study
- MDT (median duration of treatment) [ Time Frame: 24 months ]To estimate the median duration of avelumab treatment calculated from avelumab initiation in patients included in this study
- QOL (quality of life) assessed by EORTC QLQ-C30 [ Time Frame: 24 months ]To assess health-related quality of life since avelumab is started in patients included in this study
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]To assess safety profile after avelumab initiation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774901
|Contact: Elise Robertfirstname.lastname@example.org|
|Contact: Diane Berthodemail@example.com|
|Antoine THIERY VUILLEMIN||Recruiting|
|Besançon, France, 25000|
|Contact: Antoine THIERY-VUILLEMIN, MD|