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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Main

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. 5. Participants who have had brain metastases will be eligible if all of the following are true:
  • - 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. 8. Adequate organ function. 9. Age 18 years or older at registration. Main

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.
2. Nitrosoureas within 6 weeks of registration. 3. Checkpoint molecule blockade therapy within 12 weeks of registration. 4. Known or suspected allergies to any component of the vaccine. 5. Previous vaccination with 6MHP. 6. Prior treatment with CDX-1127 or other CD27 agonistic antibody. 7. Pregnancy. 8. HIV positivity or evidence of active Hepatitis C virus. 9. Female participants must not be breastfeeding. 10. A medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator. 11. New York Heart Association classification as having Class III or IV heart disease. 12. Uncontrolled diabetes, defined as having an HgbA1c > 8.5%. 13. Prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. 14. Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use. 15. Participants who have received a live vaccine within 30 days of registration. 16. Body weight < 110 pounds at registration, due to the amount and frequency with which blood will be drawn. 17. Participants with prior autoimmune pneumonitis.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03617328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Craig L Slingluff, Jr
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Craig L Slingluff, Jr., MD
Principal Investigator Affiliation University of Virginia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Arms & Interventions

Arms

Experimental: Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127

200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176. CDX-1127 (3mg/kg) will be administered intravenously on days 1, 36, and 78.

Experimental: Arm B: 6MHP/Montanide ISA-51 + polyICLC

200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176.

Interventions

Biological: - 6MHP

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

Drug: - Montanide ISA-51

Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

Drug: - polyICLC

polyICLC, local adjuvant

Drug: - CDX-1127

CDX-1127, anti-CD27 monoclonal antibody

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

Site Contact

Samantha Schaeffer

SMS6WN@uvahealth.org

434-982-6714

Virginia Commonwealth University, Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University

Richmond, Virginia, 23284

Site Contact

Faith McFadden, RN, BSN

mcfaddenfr@vcu.edu

804-628-0616

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