MelanomaPhase 1/2MEL60NCT02126579

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

A Phase 1/2 study testing Peptide Vaccine (LPV7) + Tetanus peptide, PolyICLC and Resiquimod in people with Melanoma and Metastatic Melanoma, run by Craig L Slingluff, Jr at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma, Metastatic Melanoma, Mucosal Melanoma
What is being tested?: Peptide Vaccine (LPV7) + Tetanus peptide, PolyICLC and Resiquimod
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 2 sitesUnited States
Study dates: 1 May 2014to 5 May 2021
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
Patients may have had melanoma from a cutaneous, mucosal or unknown primary site
Patients with small radiologic or clinical findings may be eligible
Patients with treated brain metastases may be eligible if the following are true:
Total number of brain metastases ever is less than or equal to 3
The brain metastases have been completely removed by surgery or have been treated completely with stereotactic radiotherapy

Show all 18Show fewer

There has been no evident growth of any brain metastases since treatment
No treated brain metastases is greater than 2 cm at the time of protocol entry
Patients must have at least 1 intact axillary and/or inguinal lymph node basin
ECOG performance status of 0-1
Lab parameters as follows:
HLA-A1, A2, A3, B35, or B51
ANC > 1000/mm3 and Platelets > 100,000/mm3 and Hemoglobin > 9 g/dL
AST and ALT up to 2.5 x ULN
Bilirubin up to 2.5 x ULN
Alkaline Phosphatase up to 2.5 x ULN
Creatinine up to 1.5 x ULN
HGBA1C level ≤ 7.5%

Who cannot join

Patients with melanoma from a uveal or ocular primary site
Patients currently receiving any systemic therapy within 4 weeks of study registration. Gamma knife or stereotactic radiosurgery must not be administered within 1 week prior to study registration. Patients who are currently receiving nitrosoureas within the preceding 6 weeks.
Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12 months.
Patients with known or suspected allergy to any component of the vaccine
HIV positive or active Hepatitis C virus
Patients receiving any of the following medications within 4 weeks are excluded:

Show all 22Show fewer

Agents with immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
Allergy desensitization injections
Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex)
Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
Interferon therapy
Interleukin-2 or other interleukins
Other investigational drugs or investigational therapy if currently receiving or have received within 1 month
Pregnancy or the possibility of becoming pregnant during the study. And women who are breastfeeding.
Must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. The following are not exclusionary:
Presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
Clinical evidence of vitiligo
Other forms of depigmenting illness
Mild arthritis requiring NSAID medications
Patients with a medical contradiction or potential problem with complying with the protocol, in the opinion of the investigator
Patients with Class III or IV heart disease (according to NYHA classification)
Patients with a body weight < 110 lbs.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Virginia
Charlottesville, Virginia, 22908
MDAnderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

Conditions: Melanoma, Metastatic Melanoma, Mucosal Melanoma
Being tested: Peptide Vaccine (LPV7) + Tetanus peptide, PolyICLC, Resiquimod, IFA
Keywords: melanoma, neoplasms, Poly ICLC, Freund's Adjuvant, Metastatic melanoma, resiquimod, adjuvants, peptide vaccine
Medical subject headings: Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peptide Vaccine (LPV7) + Tetanus peptideBiological
1.5 mL administered half intradermally and half subcutaneously.
PolyICLCOther
1 mL administered half intradermally and half subcutaneously
ResiquimodOther
500 mg applied to vaccine site after vaccine administration
IFAOther
2 mL administered half intradermally and half subcutaneously

Study groups in NCT02126579
Study group	Role	What they receive
Arm A (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: IFA
Arm B (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: PolyICLC
Arm C (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after the vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: Resiquimod
Arm D (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: PolyICLC; Other: Resiquimod
Arm E (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: PolyICLC; Other: IFA
Arm F (Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: Resiquimod; Other: IFA
Arm G(Part 1)	Experimental	Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: PolyICLC; Other: Resiquimod; Other: IFA
Arm E2	Experimental	Peptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78. Receives: Biological: Peptide Vaccine (LPV7) + Tetanus peptide; Other: PolyICLC; Other: IFA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-related Adverse Events Per Study Arm
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists.
Patients are evaluated by safety labs and physical exams to assess for toxicity.
Measured: 6 months
T Cell Response in Peripheral Blood Over Duration of Study Participation
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.
Measured: 6 months

Secondary outcomes (1)

T Cell Response and Function in Peripheral Blood
CD4+ T cell responses to peptides in the vaccine, and their function
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20145 May 2021

First posted30 Apr 2014 (estimated)
Study start1 May 2014
Primary completion20 Nov 2019
Study completion5 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MelanomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02126579
Sponsor's protocol ID: 15931
Other IDs: MEL60
Acronym: MEL60
Status last verified: Feb 2024
First submitted: 24 Apr 2014
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Patel SP, Petroni GR, Roszik J, Olson WC, Wages NA, Chianese-Bullock KA, Smolkin M, Varhegyi N, Gaughan E, Smith KT, Haden K, Hall EH, Gnjatic S, Hwu P, Slingluff CL. Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma. J Immunother Cancer. 2021 Aug;9(8):e003220. doi: 10.1136/jitc-2021-003220.
PubMed 34413169

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

All Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)
ClinicalTrials.gov ID: NCT02126579
Acronym / sponsor ID: MEL60 / 15931
Conditions: Melanoma, Metastatic Melanoma, Mucosal Melanoma
Keywords: melanoma, neoplasms, Poly ICLC, Freund's Adjuvant, Metastatic melanoma, resiquimod, adjuvants, peptide vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Craig L Slingluff, JrUniversity, hospital or other
Collaborators: University of Virginia
Study start: 1 May 2014 (actual)
Primary completion: 20 Nov 2019 (actual)
Study completion: 5 May 2021 (actual)
First posted: 30 Apr 2014 (estimated)
Results: Posted 3 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Arm A (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: IFAPeptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm B (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: PolyICLCPeptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm C (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: ResiquimodPeptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after the vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm D (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: PolyICLC, Other: ResiquimodPeptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm E (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: PolyICLC, Other: IFAPeptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm F (Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: Resiquimod, Other: IFAPeptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm G(Part 1)	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: PolyICLC, Other: Resiquimod, Other: IFAPeptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma. Resiquimod will be applied to the vaccine site immediately after vaccine administration. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.
Arm E2	Experimental	Biological: Peptide Vaccine (LPV7) + Tetanus peptide, Other: PolyICLC, Other: IFAPeptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines. Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Histologically or cytologically proven Stage IIB - IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
Patients with treated brain metastases may be eligible if the following are true:
Patients must have at least 1 intact axillary and/or inguinal lymph node basin
ECOG performance status of 0-1
Lab parameters as follows:

Key exclusion criteria (22 listed)

Patients with melanoma from a uveal or ocular primary site
Patients currently receiving any systemic therapy within 4 weeks of study registration. Gamma knife or stereotactic radiosurgery must not be administered within 1 week prior to study registration. Patients who are currently receiving nitrosoureas within the preceding 6 weeks.
Patients who have received CTLA-4, PD-1, PD-L1, CD137, or CD27 within the prior 12 months.
Patients with known or suspected allergy to any component of the vaccine
HIV positive or active Hepatitis C virus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peptide Vaccine (LPV7) + Tetanus peptide1.5 mL administered half intradermally and half subcutaneously.	Biological	Arm A (Part 1), Arm B (Part 1), Arm C (Part 1), Arm D (Part 1), Arm E (Part 1), Arm E2, Arm F (Part 1), Arm G(Part 1)
PolyICLC1 mL administered half intradermally and half subcutaneously	Other	Arm B (Part 1), Arm D (Part 1), Arm E (Part 1), Arm E2, Arm G(Part 1)
Resiquimod500 mg applied to vaccine site after vaccine administration	Other	Arm C (Part 1), Arm D (Part 1), Arm F (Part 1), Arm G(Part 1)
IFA2 mL administered half intradermally and half subcutaneously	Other	Arm A (Part 1), Arm E (Part 1), Arm E2, Arm F (Part 1), Arm G(Part 1)

Primary outcome

Number of Participants With Treatment-related Adverse Events Per Study Arm
Time frame: 6 months
Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists. Patients are evaluated by safety labs and physical exams to assess for toxicity.
T Cell Response in Peripheral Blood Over Duration of Study Participation
Time frame: 6 months
Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.

1 secondary outcome

T Cell Response and Function in Peripheral Blood
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A (Part 1)	5	5
Arm B (Part 1)	7	7
Arm C (Part 1)	4	4
Arm D (Part 1)	6	5
Arm E (Part 1 + Part 2)	16	16
Arm F (Part 1)	6	6
Arm G(Part 1)	6	5

Primary outcome: Number of Participants With Treatment-related Adverse Events Per Study Arm

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Arm A (Part 1) n = 5	Arm B (Part 1) n = 7	Arm C (Part 1) n = 4	Arm D (Part 1) n = 6	Arm E (Part 1 + Part 2) n = 16	Arm F (Part 1) n = 6	Arm G(Part 1) n = 6
BLOOD/LYMPHATIC - Other	0	0	0	0	1	0	0
EAR/LABYRINTH - Tinnitus	1	0	0	0	0	0	0
GASTROINTESTINAL - Constipation	0	0	0	0	1	1	0
GASTROINTESTINAL - Diarrhea	1	1	0	0	0	2	1
GASTROINTESTINAL - Mucositis oral	0	0	0	0	1	0	0
GASTROINTESTINAL - Nausea	1	0	1	2	5	2	2
GASTROINTESTINAL - Other	0	0	0	0	0	0	1
GASTROINTESTINAL - Vomiting	0	0	0	0	1	1	0

Population analysed: All participants enrolled and treated.

Primary outcome: T Cell Response in Peripheral Blood Over Duration of Study Participation

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Arm A (Part 1) n = 5	Arm B (Part 1) n = 7	Arm C (Part 1) n = 4	Arm D (Part 1) n = 6	Arm E (Part 1) n = 16	Arm F (Part 1) n = 6	Arm G(Part 1) n = 6
Value	2	1	0	0	4	1	1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A (Part 1)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Arm B (Part 1)	0 of 7 (0%)	7 of 7 (100%)	1 of 7
Arm C (Part 1)	0 of 4 (0%)	4 of 4 (100%)	1 of 4
Arm D (Part 1)	0 of 6 (0%)	6 of 6 (100%)	2 of 6
Arm E (Part 1 + 2)	0 of 16 (0%)	16 of 16 (100%)	1 of 16
Arm F (Part 1)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Arm G(Part 1)	0 of 6 (0%)	6 of 6 (100%)	2 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34413169Patel SP, Petroni GR, Roszik J, Olson WC, Wages NA, Chianese-Bullock KA, Smolkin M, Varhegyi N, Gaughan E, Smith KT, Haden K, Hall EH, Gnjatic S, Hwu P, Slingluff CL. Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma. J Immunother Cancer. 2021 Aug;9(8):e003220. doi: 10.1136/jitc-2021-003220.
NCI websiteLink provided by the sponsor.

Related trials for Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig L Slingluff, Jr., M.D. principal investigator

University of Virginia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Peptide Vaccine (LPV7) + Tetanus peptide, PolyICLC and Resiquimod in people with Melanoma and Metastatic Melanoma, run by Craig L Slingluff, Jr at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-related Adverse Events Per Study Arm (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02126579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.