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

NCT03774901 | Unknown Phase 2 DMC

• 2 other identifiers: P/2017/3372018-001427-38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Cancer; Penile Neoplasms; Penile Squamous Cell Carcinoma

Keywords

Immunotherapy; Penile Cancer; Penile Squamous Cell Carcinoma; Avelumab; maintenance

Outcome Measures

Primary Outcomes (1)

• PFS (progression-free survival)

  To estimate progression-free survival in patients included in this study

  24 months

Secondary Outcomes (4)

• OS (overall survival)

  32 months

• MDT (median duration of treatment)

  24 months

• QOL (quality of life) assessed by EORTC QLQ-C30

  24 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  24 months

Study Arms (1)

avelumab maintenance

EXPERIMENTAL

Avelumab will be administered at a dose of 10 mg/kg every 2 weeks with appropriate supportive care

Drug: Avelumab

Interventions

Avelumab DRUG

intravenous 10 mg/kg every 2 weeks

avelumab maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (cisplatin or carboplatin) administered as 1st line systemic treatment.
• 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
• ECOG (Eastern Cooperative Group) performance status of 0 to 2
• Adequate organ function:
• 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

You may not qualify if:

• 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.
• 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
• 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
• Active infection requiring systemic treatment
• 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).
• Previous organ transplant including stem cell allotransplantation
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Pfizer: collaborator

Study Sites (1)

Antoine THIERY VUILLEMIN

Besançon, 25000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32620211 DERIVED

MeSH Terms

Conditions

Penile Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Central Study Contacts

Elise Robert

CONTACT

0033381219086; e1robert@chu-besancon.fr

Diane Berthod

CONTACT

0033370632403; dberthod@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 13, 2018
• Study Start: March 12, 2019
• Primary Completion: September 22, 2024
• Study Completion: September 22, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

FR (1)