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

NCT04407247 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2019-0276NCI-2019-04986
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Genitourinary System Neoplasm; Malignant Solid Neoplasm; Melanoma; Colitis; Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Clinical remission/response rate of immune-mediated colitis (IMC)

  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.

  At 2 weeks after initiation of infliximab or vedolizumab with corticosteroid taper

• Treatment-related adverse events

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

  Within 3 months after initiation of infliximab or vedolizumab

Secondary Outcomes (3)

• Clinical remission/response rate of IMC

  At 4 weeks after initiation of infliximab or vedolizumab with corticosteroid taper

• Complete weaning of corticosteroid

  Within 4 weeks after infliximab or vedolizumab initiation without rebound of IMC

• Recurrent immune-related diarrhea/colitis

  Within 3 months after corticosteroid taper

Other Outcomes (6)

• Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis

  At 4 and 8 weeks after initiation of infliximab or vedolizumab treatment

• Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis

  At 8 weeks after initiation of infliximab or vedolizumab treatment

• Time duration to achieve clinical remission/response

  From initiation of infliximab or vedolizumab treatment to clinical remission/response or last follow-up, assessed up to 3 months

Study Arms (2)

Arm I (infliximab)

ACTIVE COMPARATOR

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.

Biological: Infliximab

Arm II (vedolizumab)

EXPERIMENTAL

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

Biological: Vedolizumab

Interventions

Infliximab BIOLOGICAL

Given IV

Also known as: Avakine, cA2, Remicade, Remsima

Arm I (infliximab)

Vedolizumab BIOLOGICAL

Given IV

Also known as: Entyvio, Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer''s patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer, LDP 02, LDP-02, LDP02, MLN0002, MLN02

Arm II (vedolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Colitis; Carcinoma, Non-Small-Cell Lung; Urogenital Neoplasms; Melanoma

Interventions

Infliximab; CT-P13; vedolizumab; Immunoglobulin G; Disulfides; LDP-02

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Study Officials

• Yinghong Wang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: May 29, 2020
• Study Start: July 9, 2020
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (1)