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ColitisPhase 2PHOENIX-ECPNCT07619898

PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure

A Phase 2 study testing methoxsalen, Extracorporeal photopheresis (ECP) and Vedolizumab in people with Colitis and Hepatitis, run by Therakos LLC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light. Immune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis, Hepatitis, Melanoma (Skin Cancer)
What is being tested?
methoxsalen, Extracorporeal photopheresis (ECP) and Vedolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
No sites listed yet
Study dates
Jul 2026to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.
  • Participants diagnosed with ir-colitis and/or ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (
  • Participants with endoscopic evidence of ir-colitis
  • Participants with inadequate response to corticosteroids, as defined per protocol
  • Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

Who cannot join

  • Presence of irAEs in addition to and other than ir-colitis and/or ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis/ir-hepatitis) based on ASCO guidelines.
  • Participant has a diagnosis of uveal melanoma as the sole melanoma subtype
  • Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids
  • Concurrent conditions which may require treatment with high dose corticosteroid (> 1 milligram per kilogram per day [mg/kg/day]) and interfere with the corticosteroid tapering schedule recommended by the protocol.
  • Pre-existing liver disease
  • Active alcohol use disorder
Show all 12Show fewer
  • Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.
  • Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.
  • Contraindications or known allergic reaction to any of study intervention and/or procedures
  • Participants unable to tolerate the fluid shift associated with the ECP procedure.
  • Positive result for active or previous viral infections: covid-19, hepatitis B/C, CMV, EBV, adenovirus
  • History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Therakos TKS2001 Study Team contact

855-512-3327

Clinicaltrials@therakos.com

About this study

Official title: PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety/Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)

Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.

Immune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately.

The purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.

Being tested
methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab, Infliximab, Mycophenolate Mofetil (MMF)
Keywords
Melanoma, Immune-related adverse events, Immune-related colitis, Immune checkpoint inhibitor toxicity, Checkpoint inhibitor-induced colitis, Checkpoint inhibitor-induced hepatitis, Metastatic melanoma, Unresectable melanoma, Immune checkpoint Inhibitors, Extracorporeal photopheresis, ECP, UVADEX, Device, Methoxsalen, Steroid-refractory, Corticosteroid refractory, Phase 2 clinical trial, Randomized controlled trial, Cellex, 8-Mop
Medical subject headings
Colitis, Hepatitis, Melanoma

What participants receive

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

  • methoxsalenDrug

    Also called UVADEX

    Sterile solution used in conjunction with CELLEX ECP

  • Extracorporeal photopheresis (ECP)Device

    Also called CELLEX

    Methoxsalen is used in conjunction with the CELLEX ECP

  • VedolizumabDrug

    Vedolizumab will be administered intravenously

  • InfliximabDrug

    Infliximab will be administered intravenously

  • Mycophenolate Mofetil (MMF)Drug

    Mycophenolate Mofetil will be administered orally or intravenously

  • AzathioprineDrug

    Azathioprine will be administered orally or intravenously

Study groups in NCT07619898
Study groupRoleWhat they receive
Methoxsalen in Conjunction with Extracorporeal Photopheresis System (ECP)ExperimentalParticipants will receive methoxsalen, in conjunction with ECP
Receives: Drug: methoxsalen; Device: Extracorporeal photopheresis (ECP)
Best Available Therapy (BAT)Active comparatorParticipants with ir-colitis will receive either Infliximab or Vedolizumab as per the investigator's choice. Participants with ir-hepatitis will receive Mycophenolate Mofetil (MMF) or Azathioprine as per the investigator's choice.
Receives: Drug: Vedolizumab; Drug: Infliximab; Drug: Mycophenolate Mofetil (MMF); Drug: Azathioprine

What is being measured

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

  1. Proportion of Participants Who are in Steroid-free response at Week 12 for the Randomized Immune-related Adverse Event (irAE) (ir-colitis or ir-hepatitis)

    Measured: Week 12

Secondary outcomes (12)

  1. Duration of irAE response

    Time from the start of irAE response to either the relapse of irAE (if relapse occurs), or a censoring event.

    Measured: Week 64

  2. Progression Free Survival (PFS) for Melanoma

    Measured: Week 64

  3. Overall Survival (OS)

    Measured: Week 64

  4. Proportion of Participants With at Least Stable Disease as Assessed by RECIST 1.1 at Week 12 and During Follow-up

    Measured: Week 12 and Week 64

  5. Proportion of Participants with Treatment-Emergent Adverse Event (TEAEs) per Common Toxicity Criteria for Adverse Events (CTCAE) v5.0

    Measured: From first dose of the study drug up to end of study (up to Week 64)

  6. Cumulative Systemic Corticosteroid Exposure From Randomization to Week 12

    Measured: Up to Week 12

  7. Peak Dose of Systemic Corticosteroid Exposure From Randomization to Week 12

    Measured: Up to Week 12

  8. Proportion of Participants who Completely Discontinue Systemic Corticosteroid Treatment Until Week 12

    Measured: Week 12

  9. Time to Complete Discontinuation of Systemic Corticosteroids for at Least 1 Week

    Measured: From screening up to the first documentation of the discontinuation of systemic corticosteroid (up to Week 64)

  10. Time to First Response of Randomized irAE Based on ASCO Criteria

    Measured: Week 64

  11. Proportion of Participants With at Least one irAE who Achieve Response (as Defined per ASCO Criteria) at Week 12

    Measured: Week 12

  12. Proportion of Participants With at Least One irAE That Resolves Completely (as per CTCAE v5.0) and Remains Resolved Until Week 12

    Measured: Week 12

Timeline

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

  1. First posted2 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (estimated)

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
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619898
Sponsor's protocol ID
TKS2001
Acronym
PHOENIX-ECP
Status last verified
May 2026
First submitted
19 May 2026
Last updated
2 Jun 2026
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, Extracorporeal photopheresis (ECP) and Vedolizumab in people with Colitis and Hepatitis, run by Therakos LLC.

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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Jun 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Therakos TKS2001 Study Team (855-512-3327, Clinicaltrials@therakos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who are in Steroid-free response at Week 12 for the Randomized Immune-related Adverse Event (irAE) (ir-colitis or ir-hepatitis) (time frame: Week 12). 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 NCT07619898.

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 2 Jun 2026.

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