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COMPLETEDPHASE1/PHASE2

Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

Evaluation of Safety and Durable Immunogenicity of Melanoma Vaccination, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

NCT03617328•Craig L Slingluff, Jr

View on ClinicalTrials.gov

Summary

This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence, rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration.
•2. Patients with small radiologic or clinical findings of an indeterminate nature may be eligible.
•3. Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc., Friendswood, TX) may be eligible.
•4. Participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 8 AJCC staging system.
•* Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
•* No brain metastasis is \> 2 cm in diameter at the time of registration.
•* Any neurologic symptoms attributable to brain metastases have returned to baseline.There is no evidence of new or enlarging brain metastases.
•* The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and ≤ 6 months prior to registration.
•6. ECOG performance status of 0 or 1.
•7. Ability and willingness to give informed consent.
+2 more criteria

Exclusion Criteria

•1. The following medications or treatments at any time within 4 weeks of registration:
•* Chemotherapy
•* Interferon (e.g. Intron-A®)
•* Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
•* Allergy desensitization injections
•* High doses of systemic corticosteroids
•* Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
•* Interleukins (e.g. Proleukin®)
•* Any investigational medication
•* Targeted therapies specific for mutated BRAF or for MEK
+16 more criteria

Locations (2)

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

November 13, 2018

Primary Completion Date

January 19, 2024

Completion Date

January 19, 2024

Last Updated

February 6, 2024

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

6MHP

BIOLOGICAL

Montanide ISA-51

DRUG

polyICLC

DRUG

CDX-1127

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

Inclusion Criteria

Exclusion Criteria

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