Using vaccines to enhance response to melanoma treatment
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
This study is testing whether giving certain vaccines to patients with advanced melanoma who are already receiving treatment can help their immune system work better against the cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05077137 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of administering the Tetanus Diptheria Vaccine or Polio Boost Immunization to patients with metastatic melanoma who are undergoing immune checkpoint inhibitor therapy. Participants will receive the vaccine during the fourth cycle of their treatment, and blood and tissue samples will be collected at various points to assess immune response. The goal is to determine if these vaccines can improve the effectiveness of existing melanoma therapies.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed advanced metastatic melanoma who are scheduled to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy.
Not a fit: Patients with uveal or mucosal melanoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the response rates to checkpoint therapy in melanoma patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing immune responses, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed advanced metastatic melanoma 2. Male or female participants who are at least 18 years of age on the day of signing informed consent 3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care 4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial 5. Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion 6. Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility 1. ANC \>/= 1500/uL 2. platelets \>/=100,000/uL 3. Hemoglobin \>/= 9.0 g/dL Exclusion Criteria: 1. Uveal or mucosal melanoma 2. Any women known to be pregnant or breastfeeding 3. Any prior systemic therapy for metastatic melanoma (prior surgery is allowed) 4. Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy 5. Patients with symptomatic CNS metastases and/or carcinomatous meningitis a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on \>10mg prednisone daily 6. History of or active (non-infectious) pneumonitis that required steroids 7. Active infection requiring systemic therapy 8. Known history of Human Immunodeficiency Virus (HIV) infection 9. Known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required 10. Known history of active TB (Bacillus Tuberculosis) 11. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician 12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 13. History of allogenic tissue or solid organ transplant 14. History of allergic reaction to IPOL or Td vaccine 15. Receipt of Td vaccine within 30 days prior to starting IO therapy
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Georgia Beasley, MD — Duke University
- Study coordinator: Carol Ann Wiggs, BSN
- Email: carolann.wiggs@duke.edu
- Phone: 919-684-0281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.