EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

Trial Title: EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

NCT ID: NCT06646016

Condition: Immune-related Colitis

Conditions: Official terms:
Colitis
Infliximab
Methoxsalen
Vedolizumab

Conditions: Keywords:
Melanoma
Non-Small Cell Lung Cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Methoxsalen
Description: Sterile solution used in conjunction with photopheresis procedure.
Arm group label: UVADEX in conjunction with extracorporeal photopheresis

Other name: UVADEX®, 20 micrograms per milliliter (mcg/mL)

Intervention type: Drug
Intervention name: Infliximab
Description: Infliximab will be administered intravenously.
Arm group label: Best available therapy (BAT)

Other name: REMICADE®

Other name: INFLECTRA®

Other name: IXIFI®

Other name: RENFLEXIS®

Other name: AVSOLA®

Intervention type: Drug
Intervention name: Vedolizumab
Description: Vedolizumab will be administered intravenously.
Arm group label: Best available therapy (BAT)

Other name: ENTYVIO®

Summary: The photoactivating agent UVADEX (methoxsalen) is used in conjunction with extracorporeal photopheresis (ECP) as an immunomodulatory therapy approved for the treatment of cutaneous T-cell lymphoma. ECP involves collecting whole blood from the patient, separating white blood cells (WBCs) via centrifugation, combining them with UVADEX, and then exposing them to ultraviolet A (UVA) light. All blood components, including the treated WBCs, are then returned to the patient. Immune Checkpoint inhibitor (ICI) therapy is used to treat different types of cancer, and one major side-effect of ICI therapy is immune-related colitis (ir-colitis). The main purpose of the study is to evaluate the efficacy of UVADEX in conjunction with ECP versus best available therapy (BAT) in participants with melanoma or NSCLC that suffer from ir-colitis with inadequate response to steroids.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 31, 2025

Completion date: February 19, 2027

Lead sponsor:
Agency: Therakos, LLC, a Mallinckrodt Company
Agency class: Industry

Source: Mallinckrodt

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06646016