Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

NCT ID: NCT06508827

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Anemia, Iron Deficiency; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron dextran 1000 mg IV

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

Group Type: EXPERIMENTAL

Iron dextran 1000 mg IV

Intervention Type: DRUG

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

Interventions

Iron dextran 1000 mg IV

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Mateusz Opyrchal

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mateusz Oprychal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Other Identifiers

CTO-IUSCCC-0854

Identifier Type: -

Identifier Source: org_study_id