Frontlight ResearchEarly access
WithdrawnPhase 2
Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
Key facts
- Who runs it
- Indiana University
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- May 2025
- Ended
- Jun 2026
- Type of study
- Interventional
- Treatments tested
- Iron dextran 1000 mg IV
- Record updated
- 9 July 2025
- Why it stopped
- Difficulty recruiting participants
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- ≥ 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%
Who cannot take part
- 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)
- History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
- 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
- Diagnosis of hemoglobinopathies
- Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
- Diagnosis of hemochromatosis
- Pregnant or lactating female adults
About the trial
What the trial wants to find out
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 to any standard of care chemotherapy treatment will affect the cells that are believed to make treating melanoma harder, making melanoma more responsive to the standard of care immunotherapy.
The group in the trial
- Iron dextran 1000 mg IVTreatment being tested
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Iron With Standard of Care Immunotherapy in Melanoma
- Record updated
- 9 July 2025