Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT04407247

Attivo, non recluta

Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma

Interventistico

Fase 1/2

M D Anderson Cancer Center

Sponsor: M.D. Anderson Cancer Center

Ultimo Aggiornamento: 17 dicembre 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.

Mostra Descrizione Dettagliata

Categoria di Trattamento

Inibitori dei Checkpoint, Anticorpi Monoclonali

Mutazioni richieste

Nessuno

Studio Iniziato

9 luglio 2020

Ultimo Aggiornamento dello Sponsor

17 dicembre 2025

Completamento Stimato

31 dicembre 2027

Contatto dello studio

Nome:Yinghong Wang

Email:ywang59@mdanderson.org

Telefono:713-792-7672

Idoneità

Criteri di Inclusione

* Patients who receive any type of immune checkpoint inhibitor (ICI) therapy

* Patients with peak grade >= 2 immune-related diarrhea and/or colitis (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to initiation of study treatment (infliximab/ vedolizumab)

* Patients with ability to understand and willingness to sign informed consent

* Patients with genitourinary cancer or melanoma or non-small cell lung cancer

* No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation

* Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment

Criteri di Esclusione

* Patients younger than 18 years of age

* Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics

* Patients are on concurrent immunosuppressive therapies other than what will be given for colitis

* Patients with preexisting activehistory of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation

* Pregnant and breastfeeding women, and

* Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment

* Patients who develop concurrent non-GI toxicity at the time of study treatment initiation

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare100

Bracci e Interventi

Bracci

Interventi

Tipo: Active Comparator

Descrizione: Patients receive infliximab IV over 1 hour once at week 0, 2, 6 for a total of 3 doses in the absence of disease progression or unacceptable toxicity.

Interventi:

Vedolizumab
Infliximab

Misure di Esito

Misure di Esito Primarie

Clinical remission/response rate of immune-mediated colitis (IMC)At 2 weeks after initiation of infliximab or vedolizumab with corticosteroid taper

The difference of the remission rate between standard of care (infliximab + corticosteroid) and the treatment with vedolizumab + corticosteroid will be calculated along with the 95% confidence interval.

Treatment-related adverse eventsWithin 3 months after initiation of infliximab or vedolizumab

Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency.

Misure di Esito Secondarie

Clinical remission/response rate of IMCAt 4 weeks after initiation of infliximab or vedolizumab with corticosteroid taper

Will be estimated and compared between the two treatment arms using chi-square test.

Complete weaning of corticosteroidWithin 4 weeks after infliximab or vedolizumab initiation without rebound of IMC

Will be estimated and compared between the two treatment arms using chi-square test.

Recurrent immune-related diarrhea/colitisWithin 3 months after corticosteroid taper

Will be estimated and compared between the two treatment arms using chi-square test.

Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitisAt 4 and 8 weeks after initiation of infliximab or vedolizumab treatment

Will be compared between the two treatment arms.

Histological remission (resolution of active inflammation) of immune-related diarrhea/colitisAt 8 weeks after initiation of infliximab or vedolizumab treatment

Will be compared between the two treatment arms.

Time duration to achieve clinical remission/responseFrom initiation of infliximab or vedolizumab treatment to clinical remission/response or last follow-up, assessed up to 3 months

Will be estimated using the method of Kaplan and Meier. Comparisons of the time-to-event endpoint by important subgroups will be made using the log-rank tests.

Overall survivalFrom the initiation of infliximab or vedolizumab treatment till death or last follow-up, assessed up to 3 months

Will be estimated using the method of Kaplan and Meier.

Change in levels of cytokines in tissue/blood/stool samplesBaseline up to 3 months after infliximab or vedolizumab treatment

Will be compared using 2-sample t-test.

Change in frequencies of immune cells in tissue/blood/stool samplesBaseline up to 3 months after infliximab or vedolizumab treatment

Will be compared using 2-sample t-test.

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Siti dello Studio

Questo studio ha 1 sito

M D Anderson Cancer Center

Houston, Texas, US

Nome:Yinghong Wang

In fase di reclutamento

Houston, Texas, 77030 US

M D Anderson Cancer Center

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