Penile Cancer

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Activity and Tolerability of Maintenance Avelumab Immunotherapy After First Line Polychemotherapy Including Platinum in Patients With Locally Advanced or Metastatic Squamous Cell Penile Carcinoma


Condition: Penile Cancer, Penile Neoplasms, Penile Squamous Cell Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03774901

Sponsor: Centre Hospitalier Universitaire de Besancon

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Eligibility Criteria:

  • Inclusion:
  • 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
  • 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.
  • 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 Exclusion:
  • 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
  • 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
  • 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
  • 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

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A Phase 2, Multi-centre, Open-label Study of Avelumab (MSB0010718C) in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based Chemotherapy or Progressed On or After Platinum-based Chemotherapy


Condition: Penile Cancer, Advanced Cancer, Metastatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03391479

Sponsor: University Health Network, Toronto

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma of the penis
  • Measurable disease per Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST)
  • Unresectable/metastatic disease that is unfit for platinum-based chemotherapy OR disease that has progressed on or after treatment with platinum-based chemotherapy
  • ≥18 years of age
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Exclusion Criteria:

  • Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • Major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment
  • Known symptomatic central nervous system (CNS) metastases requiring steroids
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy

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International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)


Condition: Squamous Cell Carcinoma of the Penis, Usual Type

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02305654

Sponsor: Institute of Cancer Research, United Kingdom

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Written informed consent 2. Measurable disease as determined by RECIST (version 1.1) criteria; 3. Histologically-proven squamous cell carcinoma of the penis, 4. Stage:
  • any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
  • any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
  • any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 5. Performance Status ECOG 0, 1 or 2.

Exclusion Criteria:

  1. Pure verrucous carcinoma of the penis,
  2. Nonsquamous malignancy of the penis,
  3. Squamous carcinoma of the urethra,
  4. Stage M1,
  5. Previous chemotherapy or chemoradiotherapy,
  6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.

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HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers


Condition: Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma, Human Papillomavirus Positive Penile Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02379520

Sponsor: Baylor College of Medicine

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • PROCUREMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Karnofsky score ≥ 50% 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent TREATMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Life expectancy ≥ 6 weeks. 4. Age ≥ 18 years. 5. Karnofsky score ≥ 50% 6. Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL 7. Pulse oximetry of > 90% on room air. 8. GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent 9. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent 10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.

Exclusion Criteria:

  1. PROCUREMENT
  2. Known HIV positivity. TREATMENT
  3. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
  4. Severe intercurrent infection.
  5. Pregnancy or lactation.

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