NCT04581382

Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma

Completed EARLY_PHASE1 Last updated 10 July 2025

What this trial tests

EARLY_PHASE1 trial testing Nivolumab in Melanoma in 18 participants. Completed in 6 October 2024.

Timeline

14 December 2020

Primary endpoint
6 October 2024

6 October 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	14 December 2020
Primary completion	6 October 2024
Estimated completion	6 October 2024
Sites	1 location across United States

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Radiation Therapy
• Therapeutic Exchange Plasma
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Positron Emission Tomography
• Magnetic Resonance Imaging

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as "plasmapheresis") is a way to "clean" or "flush out" the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Role of Extracellular Vesicles and Cellular Communication in Metastasis.
   Forder A, Hsing CY, Trejo Vazquez J, Garnis C. · · 2021 · cited 38× · PMID 34943937 · DOI 10.3390/cells10123429
2. Extracellular Vesicles-Based Cell-Cell Communication in Melanoma: New Perspectives in Diagnostics and Therapy.
   Kluszczynska K, Czyz M. · · 2023 · cited 15× · PMID 36674479 · DOI 10.3390/ijms24020965
3. Rescuing Cancer Immunity by Plasma Exchange in Metastatic Melanoma (ReCIPE-M1): protocol for a single-institution, open-label safety trial of plasma exchange to clear sPD-L1 for immunotherapy.
   Davidson TM, Foster N, Lucien F, Markovic S, et al · · 2022 · cited 10× · PMID 35551087 · DOI 10.1136/bmjopen-2021-050112
4. The influence of plasma sPD-L1 concentration on the effectiveness of immunotherapy in advanced NSCLC patients.
   Chmielewska I, Grenda A, Krawczyk P, Frąk M, et al · · 2023 · cited 9× · PMID 37816808 · DOI 10.1007/s00262-023-03552-x
5. Plasma exchange and radiation resensitize immunotherapy-refractory melanoma: a phase I trial.
   Orme JJ, Zhang H, Lingamaneni P, Kim Y, et al · · 2025 · cited 5× · PMID 40082438 · DOI 10.1038/s41467-025-57865-9
6. Extracellular Vesicles and Their Applications in Tumor Diagnostics and Immunotherapy.
   Strum S, Evdokimova V, Radvanyi L, Spreafico A. · · 2024 · cited 5× · PMID 39682778 · DOI 10.3390/cells13232031
7. Antibody-Based Therapeutics for the Treatment of Renal Cell Carcinoma: Challenges and Opportunities.
   Mahmoud AM, Nabavizadeh R, Rodrigues Pessoa R, Garg I, et al · · 2023 · cited 5× · PMID 36745503 · DOI 10.1093/oncolo/oyac263
8. Confronting Melanoma Radioresistance: Mechanisms and Therapeutic Strategies.
   Gorodetska I, Schulz A, Behre G, Dubrovska A. · · 2025 · cited 3× · PMID 40867277 · DOI 10.3390/cancers17162648