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Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02837042
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Lisle Nabell, University of Alabama at Birmingham

Brief Summary:
Penile squamous cell carcinoma (PSCC) is relatively rare but exhibits higher incidences in less developed countries. PSCC is a highly aggressive malignancy characterized by early spread. Pembrolizumab has recently been FDA-approved for the treatment of melanoma but will serve as the investigational agent for this penile cancer study.

Condition or disease Intervention/treatment Phase
Penile Squamous Cell Carcinoma Drug: Pembrolizumab Phase 2

Detailed Description:
This is a multicenter trial to evaluate Pembrolizumab for patients with advanced penile squamous cell carcinoma following prior chemotherapy. Participating institutions are the University of Alabama at Birmingham (coordinating center), M.D. Anderson Cancer Center, University of Michigan, University of Minnesota, and Emory University. Patients will receive intravenous Pembrolizumab every 3 weeks and undergo a clinical exam. Radiographic scans will be done at baseline and every 9 weeks. Therapy will continue until disease progression or there are intolerable toxicities.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma Following Previous Chemotherapy
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab 200 mg
Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks.
Drug: Pembrolizumab
Pembrolizumab will be administered intravenously every 3 weeks.
Other Name: Keytruda




Primary Outcome Measures :
  1. Objective tumor response rate [ Time Frame: Baseline up to two years ]
    The response rate will be evaluated every 3 weeks using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in addition to immune related criteria based on patterns of response.


Secondary Outcome Measures :
  1. Duration of response and stable disease [ Time Frame: From the first treatment up to two years ]
    Objective tumor response rates will be accumulated until disease progression by immune related criteria, death, or intolerable toxicities.

  2. Progression-free survival [ Time Frame: Baseline up to two years ]
    The duration of time from the start of treatment to the first documentation of tumor progression.

  3. Overall survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]
    Length of subject survival after starting study treatment

  4. Number of adverse events [ Time Frame: Baseline up to two years ]
    Adverse events reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) PSCC
  2. Radiologic evidence for progressive disease after ≥1 prior chemotherapy regimen
  3. Be at least 18 years of age on day of signing informed consent.
  4. Have measurable disease based on RECIST 1.1.
  5. Have a performance status of 0-2 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale.
  6. Demonstrate adequate organ function with all screening labs being performed within 14 days of treatment initiation.

    • Absolute neutrophil count (ANC) ≥1,500 /mcL
    • Platelets ≥100,000/mcL
    • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin dependency (within 7 days of assessment)
    • Serum creatinine ≤1.5 X upper limit of normal (ULN); alternately measured or calculated creatinine clearance ≥30 mL/min with creatinine levels >1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
    • Serum total bilirubin ≤1.5 X ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels >1.5 ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN or ≤ 5 X ULN for subjects with liver metastases
    • Albumin >2.5 mg/dL
    • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  7. Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
  8. Formalin-fixed paraffin embedded (FFPE) tumor tissue from previous biopsy is requested, but not mandatory.
  9. Be willing and able to provide written informed consent/assent for the trial.

Exclusion Criteria:

  1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  3. Has a known history of active TB (Bacillus Tuberculosis)
  4. Hypersensitivity to Pembrolizumab or any of its excipients.
  5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

    • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  10. Has known history of, or any evidence of active, non-infectious pneumonitis.
  11. Has an active infection requiring systemic therapy.
  12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  13. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  14. Is pregnant expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  16. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  17. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
  18. Has known active Tuberculosis infection.
  19. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Information from the National Library of Medicine

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): NCT02837042


Contacts
Contact: Lisle Nabell, MD 205-934-3061 lisle@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Pam Dixon, RN, OCN, CCRP    205-975-5387    pamdixon@uab.edu   
Principal Investigator: Lisle Nabell, MD         
Sub-Investigator: Amitkumar Mehta, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Arlet Minassian    323-865-0802    arlet.minassian@med.usc.edu   
United States, Georgia
Winship Cancer Institute at Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Marsha Williams    404-778-4063    marsha.williams@emory.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Lisle Nabell, MD University of Alabama at Birmingham

Responsible Party: Lisle Nabell, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02837042     History of Changes
Other Study ID Numbers: F160426013 (UAB 15107)
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lisle Nabell, University of Alabama at Birmingham:
penile cancer
Pembrolizumab
penile squamous cell carcinoma
squamous cell cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pembrolizumab
Antineoplastic Agents