Penile Cancer

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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

Intervention:

  • Genetic: HPV Specific T Cells
  • Drug: Cytoxan
  • Drug: Fludarabine
  • Biological: Nivolumab

Purpose: Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02379520

Sponsor: Baylor College of Medicine

Primary Outcome Measures:

  • Measure: Number of patients with dose limiting toxicity (DLT)
  • Time Frame: 6 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall response rate
  • Time Frame: 6 weeks
  • Safety Issue:

Estimated Enrollment: 32

Study Start Date: September 2015

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.

Contact:

  • Carlos Ramos, MD
  • 832-824-4817

Location:

  • Houston Methodist Hospital
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors


Condition: Various Advanced Cancer

Intervention:

  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Drug: Relatlimab
  • Drug: Daratumumab

Purpose: The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: - Anal canal cancer-No longer enrolling this tumor type - Cervical cancer - Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type - HPV positive and negative squamous cell cancer of the head and neck (SCCHN) - Merkel Cell Cancer - Nasopharyngeal cancer (NPC) - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02488759

Sponsor: Bristol-Myers Squibb

Primary Outcome Measures:

  • Measure: The safety and tolerability will be measured by the incidence of drug-related adverse events (AEs) and serious adverse events (SAEs)
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:
  • Measure: Objective response rate
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:
  • Measure: Rate of surgery delay
  • Time Frame: 6 months after the last patient receives their first dose
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Progression-free survival
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Approximately 3 years
  • Safety Issue:
  • Measure: Duration of response
  • Time Frame: Approximately 3 years
  • Safety Issue:

Estimated Enrollment: 600

Study Start Date: October 8, 2015

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types): 1. Merkel Cell Carcinoma 2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type) 3. Nasopharyngeal Carcinoma 4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penis 7. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort
  • Measurable disease by CT or MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen)
  • Men and women of age 18 or older

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Patients with hepatitis
  • Patients with HIV
  • Pregnant or breastfeeding women

Contact:

  • Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

Locations:

  • H. Lee Moffitt Cancer Center
  • Tampa Florida 33612-9497 United States
  • Winship Cancer Institute
  • Atlanta Georgia 30322 United States
  • Local Institution
  • New Orleans Louisiana 70121 United States
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Lutherville Maryland 21093 United States
  • Dana-Farber Cancer Institute
  • Boston Massachusetts 02114 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Beth Israel Desc. Med Ctr
  • Boston Massachusetts 02215 United States
  • University Of Michigan Comprehensive Cancer Center
  • Ann Arbor Michigan 48109 United States
  • Memorial Sloan-Kettering Cancer Center-Breast Center
  • New York New York 10017 United States
  • Levine Cancer Institute
  • Charlotte North Carolina 28204 United States
  • Stephenson Cancer Center
  • Oklahoma City Oklahoma 73104 United States
  • Providence Portland Medical Center
  • Portland Oregon 97213 United States
  • UPMC Eye and Ear Institute
  • Pittsburgh Pennsylvania 15213 United States
  • Sanford Clinic Clinical Research
  • Sioux Falls South Dakota 57104-4707 United States
  • Seattle Cancer Care Alliance
  • Seattle Washington 98109 United States
  • Local Institution
  • Capital Federal Buenos Aires 1426 Argentina
  • Local Institution
  • Brussels 1000 Belgium
  • Local Institution
  • Brussels 1090 Belgium
  • Local Institution
  • Bruxelles 1200 Belgium
  • Local Institution
  • Marseille Cedex 9 13273 France
  • Local Institution
  • Paris 75475 France
  • Centre Claudius Regaud
  • Toulouse Cedex 9 31059 France
  • Institut Gustave Roussy
  • Vlllejuif 94800 France
  • Local Institution
  • Essen 45147 Germany
  • Local Institution
  • Heidelberg 69120 Germany
  • Local Institution
  • Heilbronn 74078 Germany
  • Local Institution
  • Wuerzburg 97080 Germany
  • Local Institution
  • Kashiwa-shi Chiba 2778577 Japan
  • Local Institution
  • Chuo-ku Tokyo 1040045 Japan
  • Local Institution
  • Koto-ku Tokyo 135-8550 Japan
  • Local Institution
  • Ciudad de Mexico Distrito Federal 04700 Mexico
  • Local Institution
  • Oaxaca de Juarez Oaxaca 68040 Mexico
  • Local Institution
  • Merida Yucatan 97138 Mexico
  • Local Institution
  • Amsterdam 1066 CX Netherlands
  • Local Institution
  • Utrecht 3584 CX Netherlands
  • Local Institution
  • Craiova 200347 Romania
  • H. Univ. Vall dHebron
  • Barcelona 08035 Spain
  • Hospital Madrid Norte Sanchinarro
  • Madrid 28050 Spain
  • Clinica Universitaria De Navarra
  • Navarra 31008 Spain
  • Local Institution
  • Tainan 70403 Taiwan
  • Local Institution
  • Taipei 10002 Taiwan
  • Local Institution
  • Birmingham WEST Midlands B15 2TH United Kingdom
  • Local Institution
  • Glasgow G12 0YN United Kingdom
  • Local Institution
  • London W1T 7HA United Kingdom

View trial on ClinicalTrials.gov


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