Recruiting
Phase 2

Iron & Immunotherapy

Sponsor:

Indiana University

Code:

NCT06508827

Conditions

Anemia, Iron Deficiency

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iron dextran 1000 mg IV

Study Details

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

Study ID

NCT06508827

Start date

May, 2025

Status verified date

Mar, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Iron dextran 1000 mg IV

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.

Primary outcome measure

  • Erythroid progenitor cells (EPCs) detection in patient's blood [ Time Frame: Baseline, 1 week post iron infusion, 21 days post iron infusion ]

Central Contacts and Locations

Central contacts

Locations

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mateusz Opyrchal, MD, PhD

(317) 278-8845mopyrch@iu.edu

Principal Investigator:

Mateusz Opyrchal, MD

More Information

Sponsor

Indiana University

Last update posted

Mar 20, 2025

Last verified

Mar, 2025

Keywords

  • Erythroid Progenitor Cells
  • Iron
  • Anemia
  • Melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-03-20.