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Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

NCT03260023
Conditions
HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma
Interventions
TG4001, Avelumab
Biological · Drug
Lead sponsor
Transgene
Industry
Eligibility
18 Years and older
Enrollment
143 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2026
U.S. locations
2
States / cities
Jacksonville, Florida • Rochester, Minnesota
Conditions
Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Non-melanomatous Skin Cancer, Penile Cancer
Interventions
recombinant interferon alfa, isotretinoin
Biological · Drug
Lead sponsor
Hoag Memorial Hospital Presbyterian
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
1992 – 1999
U.S. locations
6
States / cities
Newport Beach, California • Bloomington, Indiana • Indianapolis, Indiana + 3 more
Conditions
Penile Carcinoma, Squamous Cell Carcinoma of the Penis
Interventions
Data Capture, Questionnaire Administration
Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
Male only
Enrollment
499 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2025
U.S. locations
1
States / cities
Houston, Texas
Conditions
Head and Neck Cancer, Cervical Cancer, Non-small Cell Carcinoma, Melanoma, Ovarian Cancer, Anogenital Cancers, HPV - Anogenital Human Papilloma Virus Infection, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Malignancy, HPV-Related Adenocarcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Associated Vaginal Adenocarcinoma, HPV-Related Endocervical Adenocarcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Verrucous Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV Positive Rectal Squamous Cell Carcinoma
Interventions
TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-204-A0201 + TSC-204-C0702, TSC-204-A0201 + TSC-200-A0201, TSC-204-C0702 + TSC-200-A0201, TSC-204-A0201 + TSC-203-A0201, TSC-204-C0702 + TSC-203-A0201, TSC-200-A0201 + TSC-203-A0201, TSC-203-A0201, TSC-204-A0101, TSC-201-B0702, TSC-204-A0201 + TSC-204-A0101, TSC-204-A0201 + TSC-201-B0702, TSC-204-C0702 + TSC-204-A0101, TSC-204-C0702 + TSC-201-B0702, TSC-200-A0201 + TSC-204-A0101, TSC-200-A0201 + TSC-201-B0702, TSC-203-A0201 + TSC-204-A0101, TSC-203-A0201 + TSC-201-B0702, TSC-202-A0201, TSC-204-A0201 + TSC-202-A0201, TSC-204-C0702 + TSC-202-A0201, TSC-200-A0201 + TSC-202-A0201, TSC-203-A0201 + TSC-202-A0201, TSC-204-A0101 + TSC-202-A0201, TSC-201-B0702 + TSC-202-A0201
Biological
Lead sponsor
TScan Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
840 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
21
States / cities
Scottsdale, Arizona • San Diego, California • New Haven, Connecticut + 17 more
Conditions
Bladder Cancer, Squamous Cell Carcinoma of the Lung, Esophageal Squamous Cell Carcinoma, Tongue Squamous Cell Carcinoma, Cutaneous Squamous Cell Cancer, Penile Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, Vulvar Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Vaginal Squamous Cell Carcinoma, Urethral Squamous Cell Carcinoma
Interventions
EVOLVE104
Drug
Lead sponsor
EvolveImmune United, Inc
Industry
Eligibility
18 Years and older
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
12
States / cities
Duarte, California • Los Angeles, California • New Haven, Connecticut + 7 more
Conditions
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Malignancy, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenocarcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV-Related Endocervical Adenocarcinoma, Cervical Cancer, Oropharynx Cancer, Anal Cancer, Vulvar Cancer, Penile Cancer, Vaginal Cancer
Interventions
E7 TCR-T cells, Aldesleukin
Biological · Drug
Lead sponsor
Christian Hinrichs
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
2
States / cities
New Brunswick, New Jersey
Conditions
Penile Squamous Cell Carcinoma
Interventions
Pembrolizumab
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older · Male only
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
3
States / cities
Birmingham, Alabama • Los Angeles, California • Atlanta, Georgia
Conditions
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma, Bladder Mixed Adenocarcinoma, Bladder Neuroendocrine Carcinoma, Bladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Collecting Duct Carcinoma, Invasive Bladder Giant Cell Urothelial Carcinoma, Invasive Bladder Lymphoepithelioma-Like Carcinoma, Invasive Bladder Nested Urothelial Carcinoma, Invasive Bladder Plasmacytoid Urothelial Carcinoma, Invasive Bladder Sarcomatoid Urothelial Carcinoma, Invasive Bladder Urothelial Carcinoma, Kidney Medullary Carcinoma, Large Cell Neuroendocrine Carcinoma, Malignant Testicular Leydig Cell Tumor, Malignant Testicular Sertoli Cell Tumor, Metastatic Bladder Carcinoma, Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma, Metastatic Bladder Giant Cell Urothelial Carcinoma, Metastatic Bladder Large Cell Neuroendocrine Carcinoma, Metastatic Bladder Lipid-Rich Urothelial Carcinoma, Metastatic Bladder Micropapillary Urothelial Carcinoma, Metastatic Bladder Plasmacytoid Urothelial Carcinoma, Metastatic Bladder Sarcomatoid Urothelial Carcinoma, Metastatic Bladder Small Cell Neuroendocrine Carcinoma, Metastatic Bladder Squamous Cell Carcinoma, Metastatic Chromophobe Renal Cell Carcinoma, Metastatic Kidney Medullary Carcinoma, Metastatic Malignant Genitourinary System Neoplasm, Metastatic Papillary Renal Cell Carcinoma, Metastatic Penile Carcinoma, Metastatic Prostate Small Cell Neuroendocrine Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma, Metastatic Urethral Carcinoma, Papillary Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage IV Bladder Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Urachal Adenocarcinoma, Urethral Clear Cell Adenocarcinoma
Interventions
Biospecimen Collection, Bone Scan, Cabozantinib S-malate, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography
Procedure · Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
314 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
581
States / cities
Birmingham, Alabama • Anchorage, Alaska • Kingman, Arizona + 377 more
Conditions
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma, Advanced Bladder Carcinoma, Advanced Breast Carcinoma, Advanced Carcinoid Tumor, Advanced Cervical Carcinoma, Advanced Colorectal Carcinoma, Advanced Gastric Carcinoma, Advanced Glioblastoma, Advanced Head and Neck Carcinoma, Advanced HER2 Positive Breast Carcinoma, Advanced Lung Carcinoma, Advanced Lung Small Cell Carcinoma, Advanced Malignant Germ Cell Tumor, Advanced Malignant Solid Neoplasm, Advanced Neuroendocrine Carcinoma, Advanced Ovarian Carcinoma, Advanced Pancreatic Carcinoma, Advanced Prostate Small Cell Neuroendocrine Carcinoma, Advanced Prostate Carcinoma, Hematopoietic and Lymphoid System Neoplasm, Multiple Myeloma, Myelodysplastic Syndrome, Advanced Basal Cell Carcinoma, Advanced Cholangiocarcinoma, Advanced Endometrial Carcinoma, Advanced Esophageal Carcinoma, Advanced Fallopian Tube Carcinoma, Advanced Hepatocellular Carcinoma, Advanced Liver Carcinoma, Advanced Lymphoma, Advanced Malignant Testicular Neoplasm, Advanced Melanoma, Advanced Merkel Cell Carcinoma, Advanced Penile Carcinoma, Advanced Primary Malignant Central Nervous System Neoplasm, Advanced Renal Cell Carcinoma, Advanced Sarcoma, Advanced Skin Squamous Cell Carcinoma, Advanced Urethral Carcinoma, Advanced Vaginal Carcinoma, Advanced Vulvar Carcinoma, Advanced Appendix Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma
Interventions
Clinical Encounter, Home Health Encounter, Quality-of-Life Assessment, Questionnaire Administration
Procedure · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
220 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
2
States / cities
Jacksonville, Florida • Grand Forks, North Dakota
Conditions
Metastatic Penile Squamous Cell Carcinoma, Stage III Penile Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Unresectable Penile Squamous Cell Carcinoma
Interventions
Enfortumab Vedotin, Computed Tomography, Magnetic Resonance Imaging
Drug · Procedure
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older · Male only
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2028
U.S. locations
3
States / cities
Phoenix, Arizona • Jacksonville, Florida • Rochester, Minnesota
Conditions
Cancer
Interventions
Fentanyl sublingual spray, Placebo
Drug
Lead sponsor
INSYS Therapeutics Inc
Industry
Eligibility
18 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Chandler, Arizona
Conditions
Small Cell Carcinoma of the Bladder, Small Cell Carcinoma of the Urinary Tract, Squamous Cell Carcinoma of the Bladder, Squamous Cell Carcinoma of the Urinary Tract, Primary Adenocarcinoma of the Bladder, Primary Adenocarcinoma of the Urinary Tract, Renal Medullary Carcinoma, Squamous Cell Carcinoma of the Penis
Interventions
Sacituzumab govitecan, Atezolizumab
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Squamous Cell Carcinoma of the Penis, Usual Type
Interventions
ILND - Inguinal Lymph Node Dissection, Paclitaxel, Ifosfamide, Cisplatin, Intensity modulated radiation treatment (IMRT), Prophylactic PLND - pelvic lymph node dissection
Procedure · Drug · Radiation
Lead sponsor
Institute of Cancer Research, United Kingdom
Other
Eligibility
18 Years and older · Male only
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2027
U.S. locations
11
States / cities
Los Angeles, California • Tampa, Florida • Atlanta, Georgia + 6 more
Conditions
Melanoma, Merkel Cell Carcinoma, Squamous Cell Carcinoma, Penile Carcinoma, Urethral Carcinoma, Extramammary Paget's Disease, Scrotal Carcinoma, Anal Cancer, Vulvar Cancer, Skin Cancer, Lymphadenopathy
Interventions
Videoscopic procedure, Open, traditional approach
Procedure
Lead sponsor
Emory University
Other
Eligibility
18 Years to 80 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Atlanta, Georgia
Conditions
Penile Cancer
Interventions
docetaxel
Drug
Lead sponsor
SWOG Cancer Research Network
Network
Eligibility
18 Years and older · Male only
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
49
States / cities
Denver, Colorado • Montrose, Colorado • Westminster, Colorado + 31 more
Conditions
Cancer
Interventions
entinostat
Drug
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
18 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2008
U.S. locations
3
States / cities
Bethesda, Maryland
Conditions
Penile Cancer
Interventions
Ifosfamide, Paclitaxel (Taxol), Cisplatin
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
14 Years and older · Male only
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2010
U.S. locations
1
States / cities
Houston, Texas
Conditions
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma, Adrenal Cortical Carcinoma, Adrenal Gland Pheochromocytoma, Anal Canal Neuroendocrine Carcinoma, Anal Canal Undifferentiated Carcinoma, Angiosarcoma, Apocrine Neoplasm, Appendix Mucinous Adenocarcinoma, Bartholin Gland Transitional Cell Carcinoma, Basal Cell Carcinoma, Bladder Adenocarcinoma, Breast Metaplastic Carcinoma, Cervical Adenocarcinoma, Cholangiocarcinoma, Chordoma, Colorectal Squamous Cell Carcinoma, Desmoid Fibromatosis, Endometrial Transitional Cell Carcinoma, Endometrioid Adenocarcinoma, Esophageal Neuroendocrine Carcinoma, Esophageal Undifferentiated Carcinoma, Extrahepatic Bile Duct Carcinoma, Extramammary Paget Disease, Fallopian Tube Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fibromyxoid Tumor, Gallbladder Carcinoma, Gastric Neuroendocrine Carcinoma, Gastric Squamous Cell Carcinoma, Gastric Undifferentiated Carcinoma, Gastrointestinal Stromal Tumor, Gestational Trophoblastic Tumor, Giant Cell Carcinoma, Human Papillomavirus-Independent Cervical Adenocarcinoma, Clear Cell-Type, Intestinal Neuroendocrine Carcinoma, Intrahepatic Cholangiocarcinoma, Lung Neuroendocrine Tumor, Lung Sarcomatoid Carcinoma, Major Salivary Gland Carcinoma, Malignant Neoplasm of Unknown Primary, Malignant Odontogenic Neoplasm, Malignant Peripheral Nerve Sheath Tumor, Malignant Solid Neoplasm, Malignant Testicular Sex Cord-Stromal Tumor, Metastatic Pituitary Neuroendocrine Tumor, Minimally Invasive Lung Adenocarcinoma, Mixed Mesodermal (Mullerian) Tumor, Mucinous Adenocarcinoma, Mucinous Cystadenocarcinoma, Nasal Cavity Adenocarcinoma, Nasal Cavity Carcinoma, Nasopharyngeal Carcinoma, Nasopharyngeal Low Grade Papillary Adenocarcinoma, Nasopharyngeal Undifferentiated Carcinoma, Oral Cavity Carcinoma, Oropharyngeal Undifferentiated Carcinoma, Ovarian Adenocarcinoma, Ovarian Germ Cell Tumor, Ovarian Mucinous Adenocarcinoma, Ovarian Squamous Cell Carcinoma, Ovarian Transitional Cell Carcinoma, Pancreatic Acinar Cell Carcinoma, Pancreatic Neuroendocrine Carcinoma, Paraganglioma, Paranasal Sinus Adenocarcinoma, Paranasal Sinus Carcinoma, Parathyroid Gland Carcinoma, PEComa, Penile Squamous Cell Carcinoma, Peritoneal Mesothelial Neoplasm, Placental Choriocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Pseudomyxoma Peritonei, Rare Disorder, Scrotal Squamous Cell Carcinoma, Seminal Vesicle Adenocarcinoma, Seminoma, Serous Cystadenocarcinoma, Small Intestinal Adenocarcinoma, Small Intestinal Squamous Cell Carcinoma, Spindle Cell Neoplasm, Teratoma With Somatic-Type Malignancy, Testicular Non-Seminomatous Germ Cell Tumor, Thyroid Gland Carcinoma, Tracheal Carcinoma, Transitional Cell Carcinoma, Ureter Adenocarcinoma, Ureter Squamous Cell Carcinoma, Urethral Adenocarcinoma, Urethral Squamous Cell Carcinoma, Vaginal Adenocarcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, Vulvar Carcinoma
Interventions
Biospecimen Collection, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
Procedure · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
798 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2027
U.S. locations
1006
States / cities
Birmingham, Alabama • Mobile, Alabama • Anchorage, Alaska + 620 more
Conditions
Penile Squamous Cell Carcinoma (PSCC)
Interventions
Gilotrif
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older · Male only
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
3
States / cities
Birmingham, Alabama • Los Angeles, California • Houston, Texas
Conditions
Anal Cancer, Cervical Cancer, Esophageal Cancer, Head and Neck Cancer, Penile Cancer, Vulvar Cancer
Interventions
human papillomavirus 16 E7 peptide, synthetic human papillomavirus 16 E6 peptide
Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 1995
U.S. locations
6
States / cities
Bethesda, Maryland • Boston, Massachusetts • Morristown, New Jersey + 1 more
Conditions
Bladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Bladder Urothelial Carcinoma, Clear Cell Renal Cell Carcinoma, Invasive Bladder Plasmacytoid Urothelial Carcinoma, Invasive Bladder Sarcomatoid Urothelial Carcinoma, Invasive Sarcomatoid Urothelial Carcinoma, Kidney Medullary Carcinoma, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm, Penile Carcinoma, Penile Squamous Cell Carcinoma, Renal Cell Carcinoma, Renal Pelvis Urothelial Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage III Bladder Cancer AJCC v8, Stage III Penile Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Stage III Renal Pelvis and Ureter Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8, Stage III Ureter Cancer AJCC v8, Stage III Urethral Cancer AJCC v8, Stage IV Bladder Cancer AJCC v8, Stage IV Penile Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8, Stage IV Renal Pelvis and Ureter Cancer AJCC v8, Stage IV Ureter Cancer AJCC v8, Stage IV Urethral Cancer AJCC v8, Ureter Urothelial Carcinoma, Urethral Urothelial Carcinoma
Interventions
Biopsy Procedure, Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
Procedure · Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
152 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2026
U.S. locations
8
States / cities
Duarte, California • Los Angeles, California • Sacramento, California + 3 more
Conditions
Appendix Adenocarcinoma, Human Papillomavirus-Related Anal Squamous Cell Carcinoma, Human Papillomavirus-Related Cervical Squamous Cell Carcinoma, Human Papillomavirus-Related Squamous Cell Carcinoma of the Penis, Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma, Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Tumor, Recurrent Merkel Cell Carcinoma, Recurrent Nasopharynx Carcinoma, Recurrent Peritoneal Malignant Mesothelioma, Recurrent Pleural Malignant Mesothelioma, Stage III Merkel Cell Carcinoma AJCC v7, Stage III Nasopharyngeal Carcinoma AJCC v7, Stage III Pleural Malignant Mesothelioma AJCC v7, Stage IV Merkel Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Carcinoma AJCC v7, Stage IV Pleural Malignant Mesothelioma AJCC v7, Stage IVA Nasopharyngeal Carcinoma AJCC v7, Stage IVB Nasopharyngeal Carcinoma AJCC v7, Stage IVC Nasopharyngeal Carcinoma AJCC v7, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
Interventions
Atezolizumab, Bevacizumab, Laboratory Biomarker Analysis, Pharmacological Study
Drug · Biological · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
133 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2027
U.S. locations
1
States / cities
Houston, Texas
Conditions
Advanced Malignant Solid Neoplasm, Carcinoma of Unknown Primary, Metastatic Adrenal Gland Pheochromocytoma, Metastatic Kidney Medullary Carcinoma, Metastatic Malignant Germ Cell Tumor, Metastatic Malignant Solid Neoplasm, Metastatic Paraganglioma, Metastatic Penile Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Small Cell Carcinoma, Stage III Adrenal Cortex Carcinoma AJCC v7, Stage IV Adrenal Cortex Carcinoma AJCC v7, Stage IV Penile Cancer AJCC v7, Stage IV Renal Cell Cancer AJCC v7, Unresectable Adrenal Gland Pheochromocytoma, Unresectable Paraganglioma, Unresectable Skin Squamous Cell Carcinoma, Unresectable Solid Neoplasm, Vascular Neoplasm
Interventions
Laboratory Biomarker Analysis, Pembrolizumab, Questionnaire Administration
Other · Biological
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
157 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2028
U.S. locations
1
States / cities
Houston, Texas
Conditions
Cervical Cancer, Throat Cancer, Oropharynx Cancer, Anal Cancer, Vulva Cancer, Vaginal Cancer, Penile Cancer, Metastatic Cancer, HPV-Related Malignancy, HPV-Related Carcinoma, HPV-Related Cervical Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Adenocarcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Associated Vaginal Adenocarcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Related Endocervical Adenocarcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV Positive Rectal Squamous Cell Carcinoma
Interventions
E7 TCR-T cells, Aldesleukin
Biological · Drug
Lead sponsor
Christian Hinrichs
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
3
States / cities
Bethesda, Maryland • New Brunswick, New Jersey