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PULSE : Activity and tolerability of maintenance avelumab immunotherapy after first line polychemotherapy including a platinum salt in patients suffering from locally advanced or metastatic squamous cell penile carcinoma (SPC)
EU CTIS ID: 2024-514997-27-00
What this study is testing
To assess the benefit of maintenance treatment with avelumab measured by disease-free survival (DFS) in patients suffering from unresectable locally advanced or metastatic SPC whose disease has not progressed after completion of first line chemotherapy including cisplatin.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Men, 18 years old and older
- Histologically confirmed unresectable locally advanced or metastatic squamous cell penile carcinoma
- Patients who have received a minimum of 3 and a maximum of 6 cycles of polychemotherapy including a platinum salt (cisplatin or carboplatin) administered as 1st line systemic treatment. In case of weekly or bi-monthly chemotherapy injection, the duration of one cycle can be of 3 weeks or 4 weeks depending on the drugs and doses prescribed. 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.
- Patients without disease-progression according to the RECIST v1.1 criteria (i.e. in complete or partial response or stable disease at inclusion) after 3 to 6 cycles of 1st line chemotherapy. Eligibility based on this criterion will be established locally by the investigator by examining pre and post-chemotherapy radiological assessments (CT/MRI)
- Estimated life expectancy of at least 3 months
- ECOG (Eastern Cooperative Group) performance status of 0 to 1
You likely can't join if
- Patients who have never received chemotherapy with a platinum salt (cisplatin or carboplatin)
- Active auto-immune 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.
- Any of the following events in the 3 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary/periphery artery bypass, symptomatic congestive heart 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).
- Active infection requiring systemic treatment
See the full eligibility criteria
Who can join
- Men, 18 years old and older
- Histologically confirmed unresectable locally advanced or metastatic squamous cell penile carcinoma
- Patients who have received a minimum of 3 and a maximum of 6 cycles of polychemotherapy including a platinum salt (cisplatin or carboplatin) administered as 1st line systemic treatment. In case of weekly or bi-monthly chemotherapy injection, the duration of one cycle can be of 3 weeks or 4 weeks depending on the drugs and doses prescribed. 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.
- Patients without disease-progression according to the RECIST v1.1 criteria (i.e. in complete or partial response or stable disease at inclusion) after 3 to 6 cycles of 1st line chemotherapy. Eligibility based on this criterion will be established locally by the investigator by examining pre and post-chemotherapy radiological assessments (CT/MRI)
- Estimated life expectancy of at least 3 months
- ECOG (Eastern Cooperative Group) performance status of 0 to 1
- Adequate bone marrow function: a – absolute neutrophil (NP) count ≥ 1500/mm3 or ≥ 1.5x109/L b – platelets ≥ 100 000/mm3 or ≥ 100.109/L c – haemoglobin ≥ 9 g/dL (the patient may have been transfused)
- Adequate renal function defined by a creatinine clearance of ≥ 30 m/min (according to the MDRD equation)
- Adequate liver function: a – total serum bilirubin ≤ 1.5 times ULN (upper limit of normal), except in cases of Gilbert’s disease when the authorised limit is ≤ 2 ULN b - AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤ 2.5 times ULN; the accepted limit in patients with liver metastases is ≤ 5 times ULN
What rules you out
- Patients who have never received chemotherapy with a platinum salt (cisplatin or carboplatin)
- Active auto-immune 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.
- Any of the following events in the 3 months prior to inclusion: myocardial infarction, severe/unstable angina, coronary/periphery artery bypass, symptomatic congestive heart 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).
- Active infection requiring systemic treatment
- Known serious hypersensitivity reaction to monoclonal antibodies (grade ≤ 3), past history of anaphylaxis or uncontrolled asthma (i.e. three or more asthma symptom control factors according to the Global Initiative for Asthma, 2015).
- Known prior severe hypersensitivity to investigational product (avelumab) or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
- Current treatment with an immunosuppressant medicinal product or treatment within 7 days prior to inclusion, EXCEPT: 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 ≥ 300/mm3
- Previous organ transplant including stem cell allotransplantation.
- Patients who have received more than one previous line of systemic treatment for penile cancer with the exception in case of a delay of more than 12 months between the end of a prior treatment and the start of the platinum based polychemotherapy
- Any screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating active infection.
- Vaccination within 4 weeks prior to the first administration of avelumab and throughout the period of the study, except with inactivated vaccines (such as, inactivated influenza vaccines).
- Men of child-bearing 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.
- People who are vulnerable under the law (minors, adults under legal protection, people deprived of their freedom)
- 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
- Persistent toxicity (excluding alopecia) due to previous treatment, NCI CTCAE v4.0 Grade> 1. Grade ≤2 sensory neuropathy, however is acceptable. If other residual grade ≤2 toxicities persist but do not carry a risk of decompensation on avelumab according to the investigator potential inclusion may be discussed with the sponsor.
- 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).
- Participation in another interventional study with a systemic anti-cancer treatment within 4 weeks prior to inclusion. Inclusion in observational or interventional studies not involving a health product is permitted. Patients with telephone follow up of toxicities and simple laboratory monitoring or other questionnaires alone may be included
The study team makes the final eligibility decision.
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 male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.