Anemia, Iron DeficiencyPhase 2NCT06508827
Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
A Phase 2 study testing Iron dextran 1000 mg IV in people with Anemia, Iron Deficiency and Melanoma, run by Indiana University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron Deficiency, Melanoma
- What is being tested?
- Iron dextran 1000 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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 join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Iron dextran 1000 mg IV
- Keywords
- Erythroid Progenitor Cells, Iron, Anemia, Melanoma
- Medical subject headings
- Anemia, Iron-Deficiency, Melanoma, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron dextran 1000 mg IVDrug
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
| Study group | Role | What they receive |
|---|---|---|
| Iron dextran 1000 mg IV | Experimental | Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment. Receives: Drug: Iron dextran 1000 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 week post iron infusion, 21 days post iron infusion
Secondary outcomes (1)
Iron dose tolerance
At least 50% of patients consented successfully receive >50% of planned iron infusion
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study startMay 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Difficulty recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Opyrchal, Indiana University
- Investigators
- Mateusz Oprychal, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508827
- Sponsor's protocol ID
- CTO-IUSCCC-0854
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron With Standard of Care Immunotherapy in Melanoma
- ClinicalTrials.gov ID
- NCT06508827
- Acronym / sponsor ID
- CTO-IUSCCC-0854
- Conditions
- Anemia, Iron Deficiency, Melanoma
- Keywords
- Erythroid Progenitor Cells, Iron, Anemia, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron dextran 1000 mg IV | Experimental | Drug: Iron dextran 1000 mg IVIron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron dextran 1000 mg IVIron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment. | Drug | Iron dextran 1000 mg IV |
Primary outcome
Erythroid progenitor cells (EPCs) detection in patient's blood
Time frame: Baseline, 1 week post iron infusion, 21 days post iron infusion
Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients
1 secondary outcome
Iron dose tolerance
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mateusz Oprychal, MD, PhD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iron dextran 1000 mg IV in people with Anemia, Iron Deficiency and Melanoma, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.