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Completed Phase 2 Interventional Results available

Phase IIB TL + YCWP + DC in Melanoma

NCT02301611
Conditions
Melanoma
Interventions
TLPLDC, Placebo
Drug
Lead sponsor
Elios Therapeutics, LLC
Industry
Eligibility
18 Years to 99 Years
Enrollment
187 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
18
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 15 more
Conditions
Melanoma, Melanoma Stage III, Melanoma Stage IV, Melanoma (Skin)
Interventions
Bempegaldesleukin, Nivolumab
Biological
Lead sponsor
Nektar Therapeutics
Industry
Eligibility
12 Years and older
Enrollment
765 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
62
States / cities
Scottsdale, Arizona • Little Rock, Arkansas • Anaheim, California + 44 more
Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma, Unresectable Melanoma
Interventions
Biospecimen Collection, Computed Tomography, Dabrafenib Mesylate, Echocardiography Test, Ipilimumab, Multigated Acquisition Scan, Nivolumab, Quality-of-Life Assessment, Trametinib Dimethyl Sulfoxide
Procedure · Drug · Biological + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
267 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2026
U.S. locations
838
States / cities
Birmingham, Alabama • Anchorage, Alaska • Fairbanks, Alaska + 528 more
Conditions
Recurrent Melanoma, Stage IV Melanoma
Interventions
bortezomib, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2001
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Intraocular Melanoma, Melanoma (Skin), Metastatic Cancer
Interventions
melphalan, regional chemotherapy, systemic chemotherapy, hepatic artery embolization
Drug · Procedure
Lead sponsor
Delcath Systems Inc.
Industry
Eligibility
18 Years to 120 Years
Enrollment
93 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
12
States / cities
Santa Monica, California • Englewood, Colorado • Tampa, Florida + 9 more
Conditions
Male Breast Cancer, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Gastric Cancer, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Melanoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Ovarian Epithelial Cancer, Recurrent Prostate Cancer, Recurrent Renal Cell Cancer, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage III Adenoid Cystic Carcinoma of the Oral Cavity, Stage III Basal Cell Carcinoma of the Lip, Stage III Colon Cancer, Stage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage III Gastric Cancer, Stage III Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage III Lymphoepithelioma of the Nasopharynx, Stage III Lymphoepithelioma of the Oropharynx, Stage III Melanoma, Stage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage III Mucoepidermoid Carcinoma of the Oral Cavity, Stage III Ovarian Epithelial Cancer, Stage III Renal Cell Cancer, Stage III Salivary Gland Cancer, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Basal Cell Carcinoma of the Lip, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage IV Gastric Cancer, Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Lymphoepithelioma of the Oropharynx, Stage IV Melanoma, Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Ovarian Epithelial Cancer, Stage IV Prostate Cancer, Stage IV Renal Cell Cancer, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Unspecified Adult Solid Tumor, Protocol Specific, Untreated Metastatic Squamous Neck Cancer With Occult Primary
Interventions
alvespimycin hydrochloride, laboratory biomarker analysis, pharmacological study
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2004
U.S. locations
1
States / cities
New York, New York
Conditions
Melanoma (Skin), Metastatic Cancer
Interventions
temozolomide, radiation therapy
Drug · Radiation
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2010
U.S. locations
45
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Beech Grove, Indiana + 24 more
Conditions
Stage IV Melanoma, Recurrent Melanoma
Interventions
recombinant interferon beta
Biological
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2007
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Melanoma
Interventions
TLN-232
Drug
Lead sponsor
Thallion Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Conditions
Phase 1, Recurrent Melanoma, Refractory Melanoma
Interventions
Cyclophosphamide, Fludarabine
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
1
States / cities
Houston, Texas
Conditions
Melanoma (Skin)
Interventions
aldesleukin, gp100 antigen, incomplete Freund's adjuvant, tyrosinase peptide
Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
16 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2000 – 2007
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Melanoma (Skin)
Interventions
carboplatin, paclitaxel, temozolomide
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 120 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2012
U.S. locations
1
States / cities
Rochester, Minnesota
Conditions
Colorectal Cancer, Triple Negative Breast Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer, Head and Neck Cancer, Ovarian Cancer, Lymphoma, Sarcoma, Bladder Cancer, Melanoma, IDH1 Mutated Solid Tumors, IDH1 Mutated or MGMT Methylated Recurrent HGG (Not Recruiting)
Interventions
Toca 511, Toca FC
Biological · Drug
Lead sponsor
Tocagen Inc.
Industry
Eligibility
18 Years to 75 Years
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
3
States / cities
Denver, Colorado • Miami, Florida • Houston, Texas
Conditions
Melanoma (Skin), Metastatic Cancer
Interventions
sargramostim
Biological
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2012
U.S. locations
87
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Aurora, Illinois + 54 more
Conditions
Cancer
Interventions
recombinant interferon alfa-2b, sodium stibogluconate, SSG & interferon
Biological · Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years to 120 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2012
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Melanoma (Skin)
Interventions
aldesleukin, filgrastim, therapeutic autologous lymphocytes, cyclophosphamide, fludarabine phosphate
Biological · Drug
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
2
States / cities
Bethesda, Maryland
Conditions
Recurrent Melanoma, Stage IV Melanoma, Tumors Metastatic to Brain
Interventions
temozolomide, thalidomide
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2003
U.S. locations
1
States / cities
Chicago, Illinois
Conditions
Melanoma
Interventions
Pembrolizumab and high dose interferon alfa-2b (HDI)
Drug
Lead sponsor
Yana Najjar
Other
Eligibility
18 Years and older
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
2
States / cities
Buffalo, New York • Pittsburgh, Pennsylvania
Conditions
Brain Metastases, Glioma of Brain, Brain Tumor, Metastatic Melanoma
Interventions
Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Bevacizumab Injection
Other
Lead sponsor
University of Southern California
Other
Eligibility
21 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Los Angeles, California
Conditions
Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer
Interventions
Autologous Tumor Infiltrating Lymphocytes, High-Dose Interleukin 2
Biological
Lead sponsor
Gregory Daniels
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
La Jolla, California
Conditions
Melanoma (Skin)
Interventions
MART-1 antigen, aldesleukin, gp100 antigen, incomplete Freund's adjuvant
Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
16 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2003
U.S. locations
1
States / cities
Bethesda, Maryland
Conditions
Melanoma (Skin)
Interventions
aldesleukin, gp100 antigen, incomplete Freund's adjuvant
Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
16 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
2
States / cities
Bethesda, Maryland
Conditions
Intraocular Melanoma, Malignant Conjunctival Neoplasm, Melanoma (Skin)
Interventions
incomplete Freund's adjuvant, multi-epitope melanoma peptide vaccine, tetanus toxoid helper peptide, biopsy
Biological · Procedure
Lead sponsor
Craig L Slingluff, Jr
Other
Eligibility
18 Years to 120 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2008
U.S. locations
1
States / cities
Charlottesville, Virginia
Conditions
Melanoma (Skin)
Interventions
MAGE-10.A2, MART-1 antigen, NY-ESO-1 peptide vaccine, sargramostim, tyrosinase peptide
Biological
Lead sponsor
Herbert Irving Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2001
U.S. locations
1
States / cities
New York, New York