Maintenance Avelumab Immunotherapy in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma (PULSE)

  • STATUS
    Recruiting
  • End date
    Sep 22, 2024
  • participants needed
    32
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 17 March 2022

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.

Details
Condition Penile Cancer, Penile Neoplasms, Penile Squamous Cell Carcinoma
Treatment Avelumab
Clinical Study IdentifierNCT03774901
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on17 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

myocardial infarction
severe/unstable angina, coronary/periphery artery bypass, symptomatic congestive heart
Active infection requiring systemic treatment
failure, cerebrovascular accident, transient ischaemic attack
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 the avelumab)
Current treatment with an immunosuppressant medicinal product or treatment within 7
days prior to inclusion, EXCEPT
Previous organ transplant including stem cell allotransplantation
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)
Diagnosis of human immunodeficiency virus (HIV) infection or disease related to the
acquired immunodeficiency syndrome (AIDS). In patients who are seropositive for HIV
but have a disease deemed to be controlled on anti-viral therapy from the opinion of
the patient's HIV contact doctor: inclusion is still possible if the CD4 count is ≥
mm3
Any screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating
active infection
Vaccination within 4 weeks prior to first administration of avelumab and throughout
the period of the study, except with inactivated vaccines (such as, inactivated
influenza vaccines)
Men of childbearing age who do not wish or cannot use 2 methods of highly effective
contraception (oral contraceptives, contraceptive injections, intra-uterine devices
dual barrier method or contraceptive patches) as described in the protocol throughout
the study and for at least 60 days after the last dose of avelumab
Other severe acute or chronic medical conditions including immune colitis
inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric
conditions including recent (within the past year) or active suicidal ideation or
behavior; or laboratory abnormalities that may increase the risk associated with study
participation or study treatment administration or may interfere with the
interpretation of study results and, in the judgment of the investigator, would make
the patient inappropriate for entry into this study

Exclusion Criteria

Patients who have never received chemotherapy with a platinum (cisplatin or
carboplatin)
Patients who have received more than one previous line of systemic treatment for
penile cancer unless in case of more than 12 months delay between the end of prior
treatment and the start of platinum containing polychemotherapy required
Patients whose disease has progressed according to RECIST v1.1 criteria after 1st line
chemotherapy for penile cancer. The cancer must not be in the progression phase at
inclusion
Past history of immunotherapy treatment with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1
anti-PD-L2, anti-CD137, or an anti- CTLA-4 antibody (including ipilimumab) or any
other antibody or medicinal products specifically targeting anti-cancer immunotherapy
Major surgery within 4 weeks or major radiotherapy within 2 weeks prior to starting
avelumab. Previous palliative radiotherapy (≤ 10 fractions) for metastatic lesions is
permitted, provided that this has been completed at least 48 hours prior to starting
avelumab
Patients with a past history of known central nervous system metastases, meningeal
carcinomatosis or spinal compression
Existence of a past history of cancer within 3 years prior to inclusion into the study
(excluding cured localised cancer such as non-melanomatous skin cancers, superficial
bladder cancers and localised prostate cancer with undetectable PSA)
Active autoimmune disease, which may deteriorate following administration of an
immunostimulatory agent. Patients suffering from type I diabetes, vitiligo, psoriasis
or hypo- or hyperthyroidism not requiring immunosuppressant treatment are eligible
Patients with uncontrolled adrenal failure
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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