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Immune-related ColitisPhase 2EPICNCT06646016

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

A Phase 2 study testing Methoxsalen, Infliximab and Vedolizumab in people with Immune-related Colitis, run by Therakos LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immune-related Colitis
What is being tested?
Methoxsalen, Infliximab and Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Dec 2025to 19 Feb 2027
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

  • 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.

Who cannot join

  • 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).
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: EPIC - A Phase 2, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) in Melanoma or Non-Small Cell Lung Cancer (NSCLC) Patients With Immune-related Colitis Induced by Immune Checkpoint Inhibitor Therapy Who Have Inadequate Response to Steroids

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.

Being tested
Methoxsalen, Infliximab, Vedolizumab
Keywords
Melanoma, Non-Small Cell Lung Cancer
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethoxsalenDrug

    Also called UVADEX®, 20 micrograms per milliliter (mcg/mL)

    Sterile solution used in conjunction with photopheresis procedure.

  • InfliximabDrug

    Also called REMICADE®, INFLECTRA®, IXIFI®, RENFLEXIS®

    Infliximab will be administered intravenously.

  • VedolizumabDrug

    Also called ENTYVIO®

    Vedolizumab will be administered intravenously.

Study groups in NCT06646016
Study groupRoleWhat they receive
UVADEX in conjunction with extracorporeal photopheresisExperimentalParticipants will receive UVADEX, in conjunction with ECP procedure twice weekly for four weeks and then every other week for 8 weeks during the 12-week treatment period according to the treatment schedule.
Receives: Drug: Methoxsalen
Best available therapy (BAT)Active comparatorParticipants will receive either infliximab or vedolizumab as per the investigator's choice during the 12-week treatment period.
Receives: Drug: Infliximab; Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants with Remission of ir-colitis at End of Treatment

    Composite endpoint of remission measured by diarrhea frequency (CTCAE grade 0 or 1 at Week 12) and colonic mucosal endoscopy score (modified Mayo Score 0 or 1 at Week 13).

    Measured: Week 12 (diarrhea frequency) / Week 13 (colonic mucosal endoscopy score)

Secondary outcomes (12)

  1. Total Duration of Remission for ir-colitis Based on the Criteria for Diarrhea

    Duration of remission is the time from when diarrhea improves until the time it comes back (if it does).

    Measured: Week 64

  2. Proportion of Participants with Complete Resolution of Diarrhea

    Complete resolution of diarrhea refers to normal stool frequency.

    Measured: Week 12

  3. Proportion of Participants with Complete Resolution of Colonic Endoscopic Changes

    Complete resolution of colonic endoscopic changes refers to no signs of inflammation or damage in the colon.

    Measured: Week 13

  4. Proportion of Participants with Corticosteroid-free Clinical Remission

    Corticosteroid-free clinical remission is assessed based on the absence of diarrhea and daily corticosteroid dose <5 mg prednisolone or equivalent at week 12.

    Measured: Week 12

  5. Changes in the Nancy Score

    The Nancy histological index comprises 3 histological items defining 5 grades of disease activity: Grade 0 is absence of significant histological disease; Grade 1 is chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 is mildly active disease; Grade 3 is moderately active disease; and Grade 4 is severely active disease.

    Measured: Week 13

  6. Proportion of Participants with Stool Calprotectin Level <150 micrograms per gram (μg/g)

    Measured: Week 26

  7. Proportion of Participants with Complete Resolution of Other Symptoms of ir-colitis

    Measured: Week 64

  8. Time to Complete Resolution of ir-colitis Based on Common Terminology Criteria for Adverse Events (CTCAE) Criteria for Colitis

    Measured: Week 64

  9. Time to Complete Resolution of Other Specified Immune-related Adverse Events (irAEs) (other than ir-colitis)

    The other specified irAEs may include pruritis, rash, inflammatory dermatitis, esophagitis, gastritis, hepatitis, pneumonitis, arthritis, myositis, polymyalgia and nephritis.

    Measured: Week 64

  10. Time to Complete Discontinuation of Systemic Corticosteroids for at least 1 Week

    This is the time taken by a participant to stop using systemic corticosteroids entirely for at least one week.

    Measured: Week 12

  11. Progression Free Survival (PFS) for Melanoma and NSCLC

    The approximate time from the start of treatment until the first incidence of cancer worsening or participants dying due to any cause.

    Measured: Week 64

  12. Overall Survival (OS)

    The approximate time from the start of treatment until death due to any cause.

    Measured: Week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start15 Dec 2025 (estimated)
  3. Primary completion6 Feb 2026 (estimated)
  4. Study completion19 Feb 2027 (estimated)

Why it stopped: Study Withdrawn by Sponsor prior to Enrollment.

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06646016
Sponsor's protocol ID
MNK60052002
Acronym
EPIC
Status last verified
Dec 2025
First submitted
15 Oct 2024
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methoxsalen, Infliximab and Vedolizumab in people with Immune-related Colitis, run by Therakos LLC at 1 site in United States.

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 8 inclusion and 14 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Proportion of Participants with Remission of ir-colitis at End of Treatment (time frame: Week 12 (diarrhea frequency) / Week 13 (colonic mucosal endoscopy score)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06646016.

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 26 Dec 2025.

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