Blood filtering therapy may ease immunotherapy gut damage
NCT ID NCT06646016
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a procedure called extracorporeal photopheresis (ECP) could help people with melanoma or lung cancer who have severe diarrhea and colon inflammation from immunotherapy drugs. ECP involves taking blood, treating white blood cells with a light-activated drug, and returning them to the body. The study was withdrawn before enrolling anyone, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants diagnosed with unresectable or metastatic melanoma or unresectable, advanced or metastatic NSCLC, who received ICI treatment with agents like anti-programmed death-1 (PD-1), anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), and had shown a response to the treatment, based on having a complete response, partial response, or stable disease determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Participants diagnosed with ir-colitis of at least Grade 2 severity based on American Society of Clinical Oncology (ASCO) Guidelines (diarrhea with an increase of ≥4 stools more than at baseline) with other causes of diarrhea and colitis ruled out. * Participants with endoscopy evidence of ir-colitis based on colonoscopy (modified Mayo Endoscopy Subscore of ≥2). * Participants with inadequate response to corticosteroids, defined as no improvement in ir-colitis after at least 72 hours of corticosteroid treatment, or relapse of ir-colitis during or after corticosteroid tapering. * Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2. * Participants who may become pregnant must have a negative serum pregnancy test, agree to use effective birth control methods during the study and for 30 days after the last treatment, and not be breastfeeding. * Participants whose sexual partner may become pregnant, must use condoms or other effective contraception, and avoid donating blood, semen, or sperm during the study and for 90 days after the last treatment. * Participants must agree to wear UVA-absorbing, wrap-around sunglasses and cover exposed skin or use a sunblock (sun protection factor \[SPF\] ≥ 15) for the 24-hour period following treatment with UVADEX, whether exposed to direct or indirect sunlight. Exclusion Criteria: * Presence of irAEs and other than ir-colitis, with severity grade \> 2 based on ASCO guidelines. * Treatment of ir-colitis with any systemic therapy other than corticosteroids. * Concurrent conditions that might require treatment with corticosteroids ≥ 1 milligram per kilogram body weight per day (mg/kg BW/day) prednisone equivalent. * Concomitant treatment with any chemotherapy or targeted therapy for malignant melanoma, NSCLC, or other cancers. * Use of any investigational agent within 5 half-lives of the study treatment. * Contraindications to study interventions or procedures (UVADEX, the ECP procedure, infliximab, or vedolizumab). * Known allergic reaction to any component of the investigational agents, 8-methoxsalen (UVADEX), infliximab, or vedolizumab. * Presence of aphakia or history of light-sensitive diseases such as lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, or albinism. * Inability to tolerate the fluid shift associated with the ECP procedure. * Positive test for human immunodeficiency virus (HIV). * Positive test for tuberculosis (blood test). * History of prior allogeneic bone marrow or solid organ transplantation. * Previous or current malignancies within the last 3 years, other than unresectable or metastatic melanoma or unresectable, advanced, or metastatic NSCLC treated with ICI. Exceptions include adequately treated basal or squamous cell skin cancer. Note: Other Inclusion/Exclusion criteria also apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.