Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Launched by INDIANA UNIVERSITY · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of giving intravenous iron to patients with melanoma who also have anemia, which is a common condition where the body doesn’t have enough healthy red blood cells. The goal is to see if the iron can help make the melanoma cells more responsive to standard treatments, known as immunotherapy. This could potentially improve the effectiveness of the treatment for patients with advanced melanoma that cannot be surgically removed.

To participate in this study, individuals need to be at least 18 years old and diagnosed with unresectable (inoperable) or metastatic melanoma. They must also have anemia, which is defined by specific blood test results. The trial is currently recruiting participants of all genders who meet these criteria. If someone joins the study, they can expect to receive iron before starting their usual immunotherapy treatment and will be closely monitored throughout the process. It's important to note that there are certain conditions that could exclude someone from participating, such as severe allergies to iron or specific medical histories.

Gender

ALL

Eligibility 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.