Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

NCT02837042 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: F160426013 (UAB 15107)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Penile Squamous Cell Carcinoma

Keywords

penile cancer; Pembrolizumab; penile squamous cell carcinoma; squamous cell cancer

Outcome Measures

Primary Outcomes (1)

• Objective Tumor Response Rate

  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.

  Baseline up to two years

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  Baseline up to two years

• Overall Survival

  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

• Number of Patients With Adverse Events

  Baseline up to two years

Study Arms (1)

Pembrolizumab 200 mg

EXPERIMENTAL

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

Interventions

Pembrolizumab DRUG

Pembrolizumab will be administered intravenously every 3 weeks.

Also known as: Keytruda

Pembrolizumab 200 mg

Eligibility Criteria

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

You may qualify if:

• Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) PSCC
• Radiologic evidence for progressive disease after ≥1 prior chemotherapy regimen
• Be at least 18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1.
• Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Demonstrate adequate organ function with all screening labs being performed within 14 days of treatment initiation.
• Absolute neutrophil count (ANC) ≥1,500 /microLiters (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
• Aspartate Transaminase (AST), also known as Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Alanine Aminotransferase (ALT), also known as Serum Glutamic-Pyruvic Transaminase (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

You may not qualify if:

• 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.
• 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.
• Has a known history of active Bacillus Tuberculosis (TB)
• Hypersensitivity to Pembrolizumab or any of its excipients.
• 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.
• 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.
• 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.
• 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.
• 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.
• Has known history of, or any evidence of active, non-infectious pneumonitis.
• Has an active infection requiring systemic therapy.
• 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.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Penile Neoplasms; Neoplasms, Squamous Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Gurudatta Naik, Scientist 3
• Organization: UAB

alkanand@uab.edu

205-996-5530

Study Officials

• Lisle Nabell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)