ColitisPhase 3iCaDNCT05947669
Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis
A Phase 3 study testing Infliximab, Methylprednisolone and Prednisolone in people with Colitis, run by Odense University Hospital at 3 sites in 2 countries.
Trial summary
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis
- What is being tested?
- Infliximab, Methylprednisolone and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Aug 2023to Sep 2028
- Phase
- Phase 3
- 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
- Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea
- No signs of colonic perforation or infection
- Age ≥ 18
- Understands the nature and purpose of the study and the study procedures and has signed informed consent
- Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period
- Histologically confirmed malignant solid tumours
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- Treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1) within the past 12 weeks. Immune checkpoint inhibitors can be administered as single agents or as combination therapy with anti-CTLA-4 and anti-PD-1
- No probability of a concomitant treatment (e.g. laxatives) other than the immune checkpoint inhibitor being the causal drug for the colitis or diarrhoea
- Prior treatment with immune checkpoint inhibitors is allowed
- Usage of prednisolone ≤ 10 mg daily for non irAE is allowed
- Diagnostic work up including screening for viral hepatic infection and QuantiFERON-TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment
- Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration.
- Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.
- Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and after the study treatment:
- for at least 6 months after the last study treatment, or depending on the duration antineoplastic treatment
- Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
Who cannot join
- Prior history of inflammatory bowel disease, colitis, or diarrhoea requiring treatment with any corticosteroid, or any other immunosuppressant medication
- Prior history of recurrent bowel disease including symptomatic diverticulosis
- Current positive testing for Clostridium difficile or other colonic infection
- Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
- Ongoing antibiotic treatment for any reason
- Treatment with systemic corticosteroids within the last four weeks prior to study enrolment (daily usage of prednisolone ≤ 10 mg for non irAE conditions is accepted)
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- Concurrent immune-related adverse events requiring immunosuppressant medication of any kind
- Known hypersensitivity or contraindications to systemic corticosteroids or infliximab
- Prior history of viral hepatitis with a positive viral load, known untreated mycobacterium tuberculosis, or known active herpes zoster infection
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Denmark2 sites, 2 recruiting
- Not yet recruiting
Department of Oncology, Aalborg University Hospital
Aalborg
Charlotte Aaquist Haslund, MD
- Recruiting
Department of Oncology Odense University Hospital
Odense
Christina H. Ruhlmann, PhD, 0045 2231 4446, christina.ruhlmann@rsyd.dk
United Kingdom1 site, 1 recruiting
- Not yet recruiting
The Royal Marsden Hospital
London
Kate Young, MD
About this study
Official title: Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis.
The main question it aims to answer is:
Read more
- Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone.
Participants will be randomised 1:1:
Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2.
Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.
- Conditions
- Colitis
- Being tested
- Infliximab, Methylprednisolone, Prednisolone
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab is available in vials of 100 mg with pharmaceutical form of concentrate for solution for infusion. Participating sites will ensure availability of infliximab as part of the hospital's standard supply for use in the study.
Methylprednisolone is available in vials of 40 mg. Methylprednisolone is a drug used for standard treatment first line for ir-colitis or diarrhoea CTCAE grade ≥ 3. Participating sites will ensure availability of methylprednisolone for use in the study as part of the hospitals standard supply.
PrednisoloneDrug
Prednisolone is available in tablets of 25 or 5 mg. Oral corticosteroids are internationally recommended as initial treatment for ir-colitis and ir-diarrhoea CTCAE grade 2 [24-27]. Participating sites will ensure availability of prednisolone for use in the study as part of the hospitals' standard supply.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care - Methylprednisolone | Active comparator | Subjects are hospitalised Day 1 and for at least 4 days. It is accepted that participating centres handle the subjects on an outpatient basis as long as all study requirements are met. Methylprednisolone 80 mg intravenously (body weight 40-80 kg; methylprednisolone 1 mg/kg if body weight < 40 or > 80 kg) will be administered from Day 1 until mCTCAE ir-colitis/diarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. During tapering, if ir-colitis/diarrhoea increases from grade 2 to ≥ grade 3, or from grade < 2 to ≥ grade 2, re-assessment including diagnostic workup will be performed, and the patient will be evaluated for rescue infliximab. Receives: Drug: Methylprednisolone; Drug: Prednisolone |
| Treatment with infliximab | Experimental | Infliximab will be administered Day 1 or latest Day 2 (within 48 hours). Infliximab infusion is handled as standard by skilled staff. A second dose of infliximab will be administered if ir-colitis/diarrhoea has not resolved to grade ≤ 2 on Day 7. Methylprednisolone 80 mg (body weight 40-80 kg; methylprednisolone 1 mg/kg if body weight < 40 or > 80 kg) intravenously is co-administered from Day 1 until mCTCAE ir-colitis/diarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. Initial dosage of infliximab is 5 mg/kg. Dosage of infliximab for subjects referred to a second dose of infliximab will be left to the discretion of the treating physician. In the event of failure of infliximab, second line biological immunosuppressant treatment will also be left to the discretion of the treating physician. Receives: Drug: Infliximab; Drug: Methylprednisolone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (days) to persistent modified CTCAE grade ≤ 1 ir-colitis/diarrhoea.
Persistent is defined as grade ≤ 1 ir-colitis/diarrhoea for five consecutive days or more with no increase in corticosteroid intake
Measured: From the first day of grade ≤ 1 ir-colitis/diarrhoea of that period (time frame: seven weeks)
Secondary outcomes (9)
Proportion of study subjects with grade ≤ 1 ir-colitis/diarrhoea at 72 hours.
Measured: Time frame: 72 hours
Proportion of study subjects with persistent grade ≤ 1 ir-colitis/diarrhoea at three weeks.
Persistent is defined as grade ≤ 1 ir-colitis/diarrhoea for five consecutive days or more
Measured: The event will be calculated from the first day of grade ≤ 1 ir-colitis/diarrhoea of that period (time frame: three weeks)
Proportion of study subjects with a corticosteroid-free clinical remission (grade ≤ 1 ir-colitis/diarrhoea) after seven weeks.
Measured: Time frame: seven weeks
Proportion of study subjects requiring rescue immunosuppressive medication
Arm A (initial corticosteroid only): infliximab if no improvement to grade ≤ 2 ir-colitis/diarrhoea after 3 days (time frame: seven weeks); Arm B (initial infliximab): second dose infliximab according to physicians decision if no improvement to grade ≤ 2 ir-colitis/diarrhoea after seven days
Measured: Time frame: seven days
Cumulative corticosteroid exposure
Measured: Time frame: seven weeks
QoL by means of EORTC-QLQ-C30
A 30-item questionaire developed to assess the quality of life of cancer patients. Item 1-28 is scaled in a 4 scale score from 'not at all' to 'very much'. Item 29-30 is a numeric rating scale from 1 to 7 assessing overall health/quality of life. One denotes very poor and 7 denotes excellent.
Measure: changes in quality of life
Measured: Change in score from baseline to 3, 12, 24, and 52 weeks after randomisation
QoL by means of selected PRO-CTCAE items
A 8 item questionnaire assessing bowel related issues. The scales ranges from eg:
Yes/No Never/rarely/occasionally/frequently/almost constant None/mild/moderate/severe/very severe Not at all/a little bit/ somewhat/quit a bit/very much Measure: changes in bowel related symptoms
Measured: Change in score from baseline to 3, 12, 24, and 52 weeks after randomisation
Proportion of study subjects with treatment related adverse events as assessed by CTCAE v5.0
Measured: Time frame: 12 weeks
Proportion of study subjects with colectomy or colitis-specific mortality
Measured: Time frame: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start22 Aug 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina H. Ruhlmann, PhD, Principal investigator, Department of Oncology, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947669
- Sponsor's protocol ID
- The ICaD Study
- Acronym
- iCaD
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Prior to study initiation, the study will be registered at www.clinicaltrials.gov. No later than six months after Follow-up completion, a study report will be completed and data displayed on www.clinicaltrials.gov. Study results will be submitted to the Clinical Trials Information System (CTIS) portal as soon as possible and no later than one year after the trial has ended. In addition, the anonymised data will be made public available through the Zenodo open data repository (CERN), or an equivalent public database.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study
- ClinicalTrials.gov ID
- NCT05947669
- Acronym / sponsor ID
- iCaD / The ICaD Study
- Conditions
- Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Royal Marsden NHS Foundation Trust
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis.
The main question it aims to answer is:
- Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone.
Participants will be randomised 1:1:
Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2.
Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care - Methylprednisolone | Active comparator | Drug: Methylprednisolone, Drug: PrednisoloneSubjects are hospitalised Day 1 and for at least 4 days. It is accepted that participating centres handle the subjects on an outpatient basis as long as all study requirements are met. Methylprednisolone 80 mg intravenously (body weight 40-80 kg; methylprednisolone 1 mg/kg if body weight < 40 or > 80 kg) will be administered from Day 1 until mCTCAE ir-colitis/diarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. During tapering, if ir-colitis/diarrhoea increases from grade 2 to ≥ grade 3, or from grade < 2 to ≥ grade 2, re-assessment including diagnostic workup will be performed, and the patient will be evaluated for rescue infliximab. |
| Treatment with infliximab | Experimental | Drug: Infliximab, Drug: Methylprednisolone, Drug: PrednisoloneInfliximab will be administered Day 1 or latest Day 2 (within 48 hours). Infliximab infusion is handled as standard by skilled staff. A second dose of infliximab will be administered if ir-colitis/diarrhoea has not resolved to grade ≤ 2 on Day 7. Methylprednisolone 80 mg (body weight 40-80 kg; methylprednisolone 1 mg/kg if body weight < 40 or > 80 kg) intravenously is co-administered from Day 1 until mCTCAE ir-colitis/diarrhoea grade ≤ 2 and hereafter converted to oral prednisolone. Initial dosage of infliximab is 5 mg/kg. Dosage of infliximab for subjects referred to a second dose of infliximab will be left to the discretion of the treating physician. In the event of failure of infliximab, second line biological immunosuppressant treatment will also be left to the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea
- No signs of colonic perforation or infection
- Age ≥ 18
- Understands the nature and purpose of the study and the study procedures and has signed informed consent
- Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period
Key exclusion criteria (9 listed)
- Prior history of inflammatory bowel disease, colitis, or diarrhoea requiring treatment with any corticosteroid, or any other immunosuppressant medication
- Prior history of recurrent bowel disease including symptomatic diverticulosis
- Current positive testing for Clostridium difficile or other colonic infection
- Current bacterial infection requiring antibiotic treatment, or systemic fungal infection
- Ongoing antibiotic treatment for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabInfliximab is available in vials of 100 mg with pharmaceutical form of concentrate for solution for infusion. Participating sites will ensure availability of infliximab as part of the hospital's standard supply for use in the study. | Drug | Treatment with infliximab |
| MethylprednisoloneMethylprednisolone is available in vials of 40 mg. Methylprednisolone is a drug used for standard treatment first line for ir-colitis or diarrhoea CTCAE grade ≥ 3. Participating sites will ensure availability of methylprednisolone for use in the study as part of the hospitals standard supply. | Drug | Standard of care - Methylprednisolone, Treatment with infliximab |
| PrednisolonePrednisolone is available in tablets of 25 or 5 mg. Oral corticosteroids are internationally recommended as initial treatment for ir-colitis and ir-diarrhoea CTCAE grade 2 [24-27]. Participating sites will ensure availability of prednisolone for use in the study as part of the hospitals' standard supply. | Drug | Standard of care - Methylprednisolone, Treatment with infliximab |
Primary outcome
Time (days) to persistent modified CTCAE grade ≤ 1 ir-colitis/diarrhoea.
Time frame: From the first day of grade ≤ 1 ir-colitis/diarrhoea of that period (time frame: seven weeks)
Persistent is defined as grade ≤ 1 ir-colitis/diarrhoea for five consecutive days or more with no increase in corticosteroid intake
9 secondary outcomes
Proportion of study subjects with grade ≤ 1 ir-colitis/diarrhoea at 72 hours.
Time frame: Time frame: 72 hours
Proportion of study subjects with persistent grade ≤ 1 ir-colitis/diarrhoea at three weeks.
Time frame: The event will be calculated from the first day of grade ≤ 1 ir-colitis/diarrhoea of that period (time frame: three weeks)
Proportion of study subjects with a corticosteroid-free clinical remission (grade ≤ 1 ir-colitis/diarrhoea) after seven weeks.
Time frame: Time frame: seven weeks
Proportion of study subjects requiring rescue immunosuppressive medication
Time frame: Time frame: seven days
Cumulative corticosteroid exposure
Time frame: Time frame: seven weeks
QoL by means of EORTC-QLQ-C30
Time frame: Change in score from baseline to 3, 12, 24, and 52 weeks after randomisation
QoL by means of selected PRO-CTCAE items
Time frame: Change in score from baseline to 3, 12, 24, and 52 weeks after randomisation
Proportion of study subjects with treatment related adverse events as assessed by CTCAE v5.0
Time frame: Time frame: 12 weeks
Proportion of study subjects with colectomy or colitis-specific mortality
Time frame: Time frame: seven weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Yes. Prior to study initiation, the study will be registered at www.clinicaltrials.gov. No later than six months after Follow-up completion, a study report will be completed and data displayed on www.clinicaltrials.gov. Study results will be submitted to the Clinical Trials Information System (CTIS) portal as soon as possible and no later than one year after the trial has ended. In addition, the anonymised data will be made public available through the Zenodo open data repository (CERN), or an equivalent public database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina H. Ruhlmann, PhD principal investigator
Department of Oncology, OUH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab, Methylprednisolone and Prednisolone in people with Colitis, run by Odense University Hospital at 3 sites in 2 countries.
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 23 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sören K. Petersen, MD (0045 2046 5726, soeren.kjaer@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (days) to persistent modified CTCAE grade ≤ 1 ir-colitis/diarrhoea. (time frame: From the first day of grade ≤ 1 ir-colitis/diarrhoea of that period (time frame: seven weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.