Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Iron With Standard of Care Immunotherapy in Melanoma

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.

Study Overview

• Status: Withdrawn
• Conditions: Melanoma; Anemia, Iron Deficiency
• Intervention / Treatment: Drug: Iron dextran 1000 mg IV

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, and transferrin saturations of less than 30%.

Cancer-associated anemia remains an underestimated and inadequately treated chronic condition that adversely affects the quality of life and overall prognosis in cancer patients. The correction of anemia in cancer patients would be a clinically applicable strategy to prevent and/or mitigate the expansion of tumor promoting erythroid progenitor cells (EPCs). Iron is an essential functional component of erythrocyte hemoglobin and is a crucial regulator of erythropoiesis. Strategies to therapeutically target the immunosuppressive machinery have emerged as a promising approach for cancer treatment. By promoting EPCs differentiation/maturation in anemic melanoma patients, immunosuppression could be mitigated and the therapeutic activity of immune checkpoint inhibitors enhanced.

A dose of intravenous iron will be given one week prior to standard of care chemotherapy and antibodies CD71 and CD235a will be used to detect EPCs in circulation and tumor microenvironment.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
      • Contact: Mateusz Opyrchal, MD
      • Contact: Anne Younger, RN; Phone Number: (317) 274-0951; Email: anefoste@iu.edu
      • Contact: Mateusz Opyrchal, MD, PhD; Phone Number: (317) 278-8845; Email: mopyrch@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iron dextran 1000 mg IV; Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.	Drug: Iron dextran 1000 mg IV; Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron dose tolerance	At least 50% of patients consented successfully receive >50% of planned iron infusion	baseline

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Mateusz Oprychal, MD, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Anemia; Iron; Melanoma; Erythroid Progenitor Cells
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Metabolic Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Anemia; Nevi and Melanomas; Skin Neoplasms; Iron Metabolism Disorders; Anemia, Hypochromic; Iron Deficiencies; Melanoma; Anemia, Iron-Deficiency; Anticoagulants; Hematinics; Plasma Substitutes; Blood Substitutes; Dextrans; Iron-Dextran Complex
• Other Study ID Numbers: CTO-IUSCCC-0854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No