Infliximab vs Vedolizumab for Colitis from Immunotherapy in Cancer Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must be taking: Immune checkpoint inhibitors
Must not be taking: Immunosuppressive therapies
Disqualifiers: Under 18, Pregnancy, Inflammatory bowel, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other immunosuppressive therapies while participating. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drugs infliximab and vedolizumab for treating colitis in cancer patients?
Research shows that both infliximab and vedolizumab are effective for treating inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Infliximab has been proven to help patients achieve remission without steroids, while vedolizumab has shown safety and effectiveness in real-world settings for similar conditions.12345
Is Infliximab or Vedolizumab safe for humans?
Infliximab and Vedolizumab are generally considered safe for treating inflammatory bowel diseases, but they can have side effects. Infliximab may cause severe infections and infusion reactions, while Vedolizumab is linked to adverse events at higher drug levels. More studies are needed to fully understand their safety profiles.678910
How do infliximab and vedolizumab differ from other drugs for colitis in cancer patients?
Infliximab and vedolizumab are unique because they offer different mechanisms of action compared to traditional treatments. Infliximab is an anti-TNF (tumor necrosis factor) drug, while vedolizumab targets the α4β7 integrin, which helps control immune cell movement in the gut, making them suitable for patients who do not respond to or cannot tolerate other treatments.47111213
Research Team
YW
Yinghong Wang
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with genitourinary cancer, melanoma, or non-small cell lung cancer who have developed grade 2 or higher colitis from immune checkpoint inhibitor therapy. They must not have active GI infections, inflammatory bowel disease, radiation enterocolitis, or be on other immunosuppressive drugs. Pregnant women and those under 18 are excluded.Inclusion Criteria
I don't have an active GI infection as confirmed by tests or my doctor.
I have genitourinary cancer, melanoma, or non-small cell lung cancer.
I can understand and am willing to sign the informed consent.
See 3 more
Exclusion Criteria
I am younger than 18 years old.
I do not have active inflammatory bowel disease or radiation enterocolitis.
I developed side effects not related to my digestive system when I started the study treatment.
See 4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients receive infliximab or vedolizumab intravenously over 1 hour at weeks 0, 2, and 6 for a total of 3 doses
6 weeks
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Weekly visits for 1 month, then at 2 and 3 months
Long-term follow-up
Participants are monitored for long-term outcomes and survival
Up to 3 months
Treatment Details
Interventions
- Infliximab (Monoclonal Antibodies)
- Vedolizumab (Monoclonal Antibodies)
Trial OverviewThe study is testing the effectiveness of monoclonal antibodies infliximab and vedolizumab in treating colitis caused by immune checkpoint inhibitors in patients with certain cancers. It aims to determine the best treatment strategy for this condition.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (vedolizumab)Experimental Treatment1 Intervention
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.
Group II: Arm I (infliximab)Active Control1 Intervention
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.
Infliximab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Remicade for:
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Plaque Psoriasis
🇺🇸 Approved in United States as Remicade for:
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Plaque Psoriasis
🇨🇦 Approved in Canada as Remicade for:
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Plaque Psoriasis
🇯🇵 Approved in Japan as Remicade for:
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Plaque Psoriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Trials
3107
Patients Recruited
1,813,000+
National Cancer Institute (NCI)
Collaborator
Trials
14080
Patients Recruited
41,180,000+
References
Irish data on the safety and efficacy of vedolizumab in the treatment of inflammatory bowel disease. [2021]This study reviews the safety and efficacy of treatment with vedolizumab for patients with inflammatory bowel disease across 9 Irish hospitals. It generates valuable and timely real-world data on treatment outcomes to add to the existing evidence base. Our population represents a refractory cohort with most patients previously exposed to at least one anti-TNFa agent and expressing an inflammatory phenotype. Results are reassuringly similar to larger international studies with additional insights into potential predictors of treatment response. This study further supports the safety and efficacy of vedolizumab in the treatment of inflammatory bowel disease. Key SummaryVedolizumab has growing real world data on its safety and efficacy in the treatment of IBD. Data on predictors of response are lacking. Studies such as VARSITY require new real-world data to help identify the place VDZ will occupy in the treatment algorithm for IBDThis study provides national Irish data on the safety and efficacy of VDZ in the treatment of IBD. It gives insight into various predictors of response for both UC and CD. It strengthens the available body of evidence on the use of VDZ and helps us determine its position on the treatment algorithm.
Comparative Efficacy for Infliximab Vs Vedolizumab in Biologic Naive Ulcerative Colitis. [2022]Comparative effectiveness studies are needed to help position therapies for ulcerative colitis (UC). We compared the efficacy of infliximab vs vedolizumab for moderate to severe biologic-naïve UC using patient-level data from clinical trial program data sets.
Efficacy of infliximab for luminal and fistulizing Crohn's disease and in ulcerative colitis. [2022]Infliximab is arguably the first major advance in therapy for inflammatory bowel disease in more than a quarter of a century. Although it is important to distinguish efficacy from effectiveness, the data from clinical practice mirror those from randomized controlled trials. Infliximab has proven efficacious for luminal manifestations of Crohn's disease (CD) regardless of location. It also has proven efficacy in the subset of penetrating disease to the skin and perianal area, and it increases rates of steroid-free remission. These benefits are reflected in improved quality of life, with limited data showing that infliximab can decrease rates of hospitalization and CD-related surgery. Infliximab also has proven to be efficacious in patients with ulcerative colitis (UC) and has increased rates of steroid-free remission. Whether infliximab will have an impact on the risk of colorectal cancer in UC and Crohn's colitis has yet to be determined. The combination of strong evidence from large randomized controlled trials with substantial examination of use in the practice setting has moved biologic therapy with infliximab from novel to mainstream. In this review, the data for the efficacy of infliximab in controlled trials will be discussed in the context of real world effectiveness.
Uptake of a Switching Program for Patients Receiving Intravenous Infliximab and Vedolizumab to Subcutaneous Preparations. [2022]Recent trials support the clinical efficacy and safety of subcutaneous infliximab (IFX) or vedolizumab (VDZ) for Inflammatory Bowel Disease (IBD). We evaluated the uptake and rationale for choosing to switch from intravenous infusions to subcutaneous injections.
Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: a two-center observational study. [2022]Current treatment guidelines for immune-mediated diarrhea and colitis (IMDC) recommend steroids as first-line therapy, followed by selective immunosuppressive therapy (SIT) (infliximab or vedolizumab) for refractory cases. We aimed to compare the efficacy of these two SITs and their impact on cancer outcomes.
Safety aspects of infliximab in inflammatory bowel disease patients. A retrospective cohort study in 100 patients of a German University Hospital. [2019]Infliximab, a chimeric anti-tumour necrosis factor monoclonal antibody with potent anti-inflammatory effects, represents an effective treatment option in patients with severe inflammatory bowel disease (IBD). Serious side-effects of such an immunomodulating therapy are speculated and therefore we reviewed our clinical experience in a retrospective safety study looking upon a single cohort of 100 IBD patients from a large German University Hospital.
Vedolizumab as a Treatment for Crohn's Disease and Ulcerative Colitis. [2022]The management of Crohn's disease and ulcerative colitis has become increasingly complex. With the current utilization of immunosuppressive therapies earlier in the disease course for patients presenting with moderate to severe disease, there is a great need for additional biologic agents targeting inflammatory mediators other than anti-tumor necrosis factor-α (anti-TNF) agents. Although anti-TNF agents have positively impacted the treatment of inflammatory bowel disease, many patients can lose their response or develop intolerance to these agents over time through the formation of antidrug antibodies. Furthermore, a sizeable percentage of patients are primary nonresponders to anti-TNF drugs. Vedolizumab (Entyvio, Takeda Pharmaceuticals), a monoclonal antibody to the α4β7 integrin, inhibits gut lymphocyte trafficking and has been demonstrated to be an effective and safe agent for the treatment of both Crohn's disease and ulcerative colitis. This article reviews the clinical trial evidence and rationale for the use of vedolizumab in moderate to severe Crohn's disease and ulcerative colitis.
Association of Infliximab and Vedolizumab Trough Levels with Reported Rates of Adverse Events: A Cross-Sectional Study. [2021]Infliximab and vedolizumab are effective treatments for inflammatory bowel disease (IBD), although associated with adverse events (AE). While low or non-existent drug levels and positive antidrug antibodies have been associated with therapeutic failure, there is no clear association between higher drug levels and AE. A cross-sectional study consisting of Crohn's disease (CD) and ulcerative colitis (UC) patients receiving infliximab or vedolizumab at the Sheba Medical Center was performed. Patients completed a questionnaire regarding AEs related to biological therapy. Serum trough levels obtained on the same day were analyzed. Objective measures of outcomes were retrieved from medical records. Questionnaires were completed by infliximab (n = 169) and vedolizumab (n = 88)-treated therapy patients. Higher infliximab levels were only numerically associated with the occurrence of at least one AE (p = 0.08). When excluding fatigue and abdominal pain, higher infliximab levels were statistically associated with the occurrence of at least one AE (p = 0.03). Vedolizumab drug levels > 18 μg/mL were also linked with the occurrence of more AEs. No specific association was observed between the increased levels of either infliximab or vedolizumab and specific AEs (neurological symptoms, upper GI symptoms, infectious complications, and musculoskeletal symptoms). As significant AEs are very rare, additional multi-center studies are required.
Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation. [2022]Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
Infliximab use in children and adolescents with inflammatory bowel disease. [2015]Infliximab is a chimeric monoclonal antibody (75% human, 25% murine) against tumor necrosis factor-alpha, a cytokine with a central role in the pathogenesis of inflammatory bowel disease. Large randomized controlled trials have shown the efficacy and safety of infliximab for the induction and maintenance of remission in adult patients with active Crohn disease (CD). In children and adolescents, mostly small, nonrandomized, non-placebo-controlled studies have supported the notion that infliximab is a potent drug in a population that does not respond to standard therapies. The safety of infliximab is of major concern, and the most frequent severe adverse events are related to severe infections and reactivation of tuberculosis. Non-life-threatening infusion reactions occur rather frequently and seem to be related to the formation of antibodies. The indications for infliximab treatment are therapy-resistant luminal CD (no efficacy or insufficient efficacy of conventional treatment) and therapy-resistant fistulas. An efficient remission induction strategy consists of 3 initial infliximab infusions at 0, 2, and 6 weeks in a dosage of 5 mg/kg to sustain remission. Patients needing maintenance therapy are subsequently treated with an infliximab infusion every 8 weeks. There are indications that the early stages of CD may be more susceptible to immunomodulation, and the natural history of CD may be altered by the introduction of infliximab early in the disease process instead of waiting until conventional therapy has failed. Major points of discussion are whether infliximab maintenance treatment should be episodic (on demand) or scheduled and when infliximab therapy can be discontinued.
Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis. [2022]There are limited comparative data for infliximab and vedolizumab in inflammatory bowel disease patients.
Vedolizumab for inflammatory bowel disease: From randomized controlled trials to real-life evidence. [2018]The biologic antitumor necrosis factor alpha (anti-TNFα) agents have revolutionised the treatment of inflammatory bowel disease (IBD). However, some patients experience primary nonresponse, loss of response, or intolerance. Therefore, introducing a newer class of therapy with a mechanism of action that acts on different inflammatory pathways involved in IBD pathogenesis is appealing. Vedolizumab is a fully humanised monoclonal antibody that selectively targets α4β7 integrin. Based on the results of the pivotal clinical GEMINI trials, vedolizumab was approved for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) refractory or intolerant to either conventional therapy or TNFα inhibitors. This review describes the efficacy, safety, and tolerability of vedolizumab reported in both randomized, controlled, clinical trials and from real-world experience in patients with UC and CD in order to identify its place in treatment algorithms for IBD.
Use of Vedolizumab in Inflammatory Bowel Disease: A Single-Center Experience. [2022]Vedolizumab, which is a monoclonal antibody that selectively binds to α4β7 integrin in the gastrointestinal system, may be an effective and safe treatment alternative in those with anti-tumor necrosis factor-resistant inflammatory bowel disease.