Status:
WITHDRAWN
Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
Lead Sponsor:
Indiana University
Conditions:
Anemia, Iron Deficiency
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Anemia is a common complication among cancer patients and is negatively associated with overall prognosis and therapeutic outcomes. The purpose of this study is to see if giving a dose of iron prior t...
Detailed Description
This is a pilot single arm, non-randomized study involving adult patients with melanoma receiving standard of care treatment with hemoglobin levels less than 13 g/dl, ferritin levels below 100 ng/ml, ...
Eligibility Criteria
Inclusion
- ≥ 18 years old adults at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Biopsy confirmed melanoma
- Eligible for standard of care treatment
- Plan to undergo immunotherapy in neoadjuvant or metastatic setting
- ECOG performance status 0-2
- Anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30%
Exclusion
- History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
- Diagnosis of hemoglobinopathies
- Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
- Diagnosis of hemochromatosis
- 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).
- Pregnant or lactating female adults
- Active infections which in research teams' opinion increases risk for toxicities
- Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06508827
Start Date
May 1 2025
End Date
June 1 2026
Last Update
July 9 2025
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