Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT04407247

Actif, ne recrute pas

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

Interventionnel

Phase 1/2

M D Anderson Cancer Center

Sponsor: M.D. Anderson Cancer Center

Dernière synchronisation : 17 décembre 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

Afficher la description détaillée

Catégorie de traitement

Inhibiteurs de points de contrôle, Anticorps monoclonaux

Mutations requises

Aucun

Essai commencé

9 juillet 2020

Dernière mise à jour par le sponsor

17 décembre 2025

Achèvement estimé

31 décembre 2027

Contact de l'étude

Nom:Yinghong Wang

E-mail:ywang59@mdanderson.org

Téléphone:713-792-7672

Éligibilité

Critères d'inclusion

* 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

Critères d'exclusion

* 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

Pensez-vous que cet essai apparaît incorrectement ?

Détails de la conception

AllocationRandomized

Modèle d'interventionParallel Assignment

MasquageNone (Open Label)

Nombre à inscrire100

Bras et interventions

Bras

Interventions

Type : Active Comparator

Description : 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.

Interventions :

Vedolizumab
Infliximab

Mesures des résultats

Mesures des résultats primaires

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.

Mesures des résultats secondaires

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.

Mettre l'essai en favori

Partager l'essai

Télécharger l'essai

Pensez-vous que cet essai apparaît incorrectement ?

Signaler l'essai

Télécharger l'essai

Sites d'essai

Cette étude compte 1 site d'essai

M D Anderson Cancer Center

Houston, Texas, US

Nom:Yinghong Wang

Recrutement en cours

Houston, Texas, 77030 US

M D Anderson Cancer Center

Loading Maps...