Using intravenous iron to improve immunotherapy outcomes in melanoma patients with anemia
Iron With Standard of Care Immunotherapy in Melanoma
PHASE2 · Indiana University · NCT06508827
This study is testing if giving iron to melanoma patients with anemia before their immunotherapy can help the treatment work better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Drugs / interventions | immunotherapy, chemotherapy |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06508827 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of intravenous iron on adult melanoma patients who are anemic and receiving standard immunotherapy. By administering a dose of iron prior to treatment, the study aims to enhance the differentiation of erythroid progenitor cells, potentially improving the effectiveness of immunotherapy. The study is non-randomized and will monitor changes in EPCs in circulation and the tumor microenvironment. Patients must have specific hemoglobin and ferritin levels to qualify for participation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-confirmed melanoma and anemia who are eligible for standard immunotherapy.
Not a fit: Patients with a history of severe allergic reactions to intravenous iron or those with certain blood disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment responses in melanoma patients suffering from anemia.
How similar studies have performed: While the approach of combining iron therapy with immunotherapy is innovative, similar strategies targeting anemia in cancer treatment have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ≥ 18 years old adults at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Biopsy confirmed melanoma 4. Eligible for standard of care treatment 5. Plan to undergo immunotherapy in neoadjuvant or metastatic setting 6. ECOG performance status 0-2 7. Anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30% Exclusion Criteria: 1. History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments 2. Diagnosis of hemoglobinopathies 3. Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed) 4. Diagnosis of hemochromatosis 5. Symptomatic brain metastases that require local treatment (brain metastasis which will be treated with systemic immunotherapy or treated metastasis with without need for steroids for symptomatic management are eligible). 6. Pregnant or lactating female adults 7. Active infections which in research teams' opinion increases risk for toxicities 8. Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.
Where this trial is running
Indianapolis, Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Mateusz Oprychal, MD, PhD — Indiana University
- Study coordinator: Anne Younger, RN
- Email: anefoste@iu.edu
- Phone: (317) 274-0951
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.
Conditions: Anemia, Iron Deficiency, Melanoma, Erythroid Progenitor Cells, Iron, Anemia