Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist
Activation of pDCs at the Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist
2 other identifiers
interventional
47
1 country
1
Brief Summary
The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune system against melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Start
First participant enrolled
May 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedResults Posted
Study results publicly available
August 13, 2021
CompletedAugust 13, 2021
July 1, 2021
10.2 years
August 17, 2009
July 20, 2021
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Immune Responses of Vaccine+R848 to Vaccine Alone
T-cell response to gp100(g209-2M) +/- MAGE3 measured at 8 weeks using a tetramer/multimer assay measured by flow cytometry. Based on the number of gp100(g209-2M) +/- MAGE3 T-cells measured, categorized as either immune responders or immune non-responders. T-cell response to the gp100(g209-2M) + /- MAGE3 peptide in each participant defined as ≥0.1% gp100(g209-2M) tetramer+ cells in the CD8+ T-cell population or ≥0.1% MAGE3 multimer cells in the CD4+ T-cell population.
8 weeks
Secondary Outcomes (1)
Composite of Immune Cell Infiltration for pDCs, mDCs, and NK Cells in Tumor Biopsy Samples
8 weeks
Study Arms (3)
Group 1: gp100 and MAGE-3 + R848
ACTIVE COMPARATOR1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week. After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.
Group 2: gp100 and MAGE-3
ACTIVE COMPARATOR1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week. After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.
Group 3-Metastatic Melanoma: gp100 + MAGE-3 + R848
ACTIVE COMPARATOR1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week. After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.
Interventions
1 ml of gp100 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.
Applied to the gp100 vaccine injection site immediately following the injection, allowed to air dry for 30 minutes then covered with gauze dressing.
1 ml of MAGE-3 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.
Eligibility Criteria
You may qualify if:
- HLA-A\*0201 positive (to enable immunization with the HLA class I restricted gp100(g209-2M) peptide). Stage IIB or IIC patients will be enrolled after review and approval by the PI. (a tool to determine the projected survival at 5 years, like, but not limited to, the nomogram at www.melanomaprognosis.org. If the projected survival is less than 50% at 5 years, then the patient is considered for enrollment. This is with the recognition that the adjuvant, if effective offers a significant impact in that group of stage II patients.)
- Patients \>/= 18 years old with histologically documented metastatic melanoma with a. (Metastatic disease cohort) Measurable disease, stage IIIB, IIIC (in transit lesions with or without nodal metastases) that includes lesions accessible for biopsies or IV M1B b. (Adjuvant cohort) subjects who are NED and stage III or IV. This includes patients with stage IV disease resected to NED. Stage IIB or IIC patients will be enrolled after review and approval by the PI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- At least 2 biopsiable easily accessible cutaneous and subcutaneous lesions in patients in the metastatic disease cohort
- White Blood Count (WBC) \>/= 3000/mm\^3 (part 1 \& 2)
- Platelet count \>/= 90,000/mm\^3 (part 1 \& 2)
- Serum alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) \</= 3 X upper limit of normal (ULN) (part 1 \& 2)
- Total bilirubin \</= 2 X ULN, except for patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl Total bilirubin \</= 2 X ULN, except for patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (part 1 \& 2)
- Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Negative pregnancy test for women of childbearing potential (WOCBP) A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses at any time in the preceding 12 consecutive months)
- Patients of both gender must practice a barrier method of birth control while participating in this trial.
You may not qualify if:
- Active autoimmune disease requiring active therapy with any form of steroid or immunosuppressive therapy or a documented history of any of the following: inflammatory bowel disease; regional enteritis; systemic lupus erythematosis; Sjogren's syndrome; inflammatory neurologic disorder such as multiple sclerosis; or any immune mediated disease that can cause life-threatening symptoms or severe organ/tissue damage in the opinion of the principle investigator.
- Concurrent systemic or inhaled steroid therapy
- Any form of active primary or secondary immunodeficiency
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years
- History of immunization with gp100(g209-2M)
- Active systemic infections requiring intravenous antibiotics
- Women who are breastfeeding
- Prior systemic therapy, radiation therapy or intracavitary surgery (intra-thoracic, intra-abdominal or intracranial) within 28 days of starting study treatment.
- Patients on chronic anticoagulation such as Aspirin, Plavix, or Coumadin who cannot have anticoagulation held for procedures are not eligible due to the need for leukapheresis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Davis, PHD., Chair, Melanoma Medical Oncology
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael A. Davies, PHD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2009
First Posted
August 18, 2009
Study Start
May 20, 2010
Primary Completion
July 20, 2020
Study Completion
July 20, 2020
Last Updated
August 13, 2021
Results First Posted
August 13, 2021
Record last verified: 2021-07