Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

NCT06508827 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CTO-IUSCCC-0854
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Anemia, Iron Deficiency; Melanoma

Keywords

Erythroid Progenitor Cells; Iron; Anemia; Melanoma

Outcome Measures

Primary Outcomes (1)

• Erythroid progenitor cells (EPCs) detection in patient's blood

  Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients

  Baseline, 1 week post iron infusion, 21 days post iron infusion

Secondary Outcomes (1)

• Iron dose tolerance

  baseline

Study Arms (1)

Iron dextran 1000 mg IV

EXPERIMENTAL

Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.

Drug: Iron dextran 1000 mg IV

Interventions

Iron dextran 1000 mg IV DRUG

Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.

Iron dextran 1000 mg IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Melanoma; Anemia

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Mateusz Oprychal, MD, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 18, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06