Checkpoint Inhibitor Induced Colitis and Arthritis -Immunomodulation With IL-6 Blockade and Exploration of Disease Mechanisms (COLAR)
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|ClinicalTrials.gov Identifier: NCT03601611|
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Colitis Arthritis||Drug: Tocilizumab (RoACTEMRA®)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
- Patients will receive tocilizumab 8 mg/kg given as an IV infusion over 60 minutes every 4 weeks (Q4W) for at least 2 cycles or until worsening or lack of improvement of diarrhea and/or colitis and/arthritis, in case of unacceptable toxicity, withdrawal of consent or clear clinical deterioration, according to investigator's judgment.
At the initial stage, 7 patients will be enrolled and evaluated for symptom improvement. In case of ≤ 4 patients with at least one grade improvement, accrual will be terminated. If ≥ 5 patients with at least one grade improvement will be observed at the first stage, 13 additional patients will be entered at the second stage to achieve a target sample size of 20 evaluable patients. Further exploration of the treatment strategy is warranted, if at least one grade improvement is observed for ≥14 patients.
|Masking:||None (Open Label)|
|Official Title:||Checkpoint Inhibitor Induced Colitis and Arthritis -Immunomodulation With IL-6 Blockade and Exploration of Disease Mechanisms|
|Actual Study Start Date :||January 1, 2019|
|Actual Primary Completion Date :||January 28, 2020|
|Actual Study Completion Date :||January 28, 2020|
Tocilizumab 8 mg/kg is to be given as an IV infusion over 60 minutes every 4 weeks (Q4W).
Drug: Tocilizumab (RoACTEMRA®)
Prednisolon will be given in case of worsening of symptoms
Other Name: Prednisolon
- Rate of at least one grade improvement using the NCI CTCAE v5.0 [ Time Frame: 2 months ]Clinical benefit of IL-6 inhibition by tocilizumab on diarrhea and/or colitis and/or arthritis induced by checkpoint inhibitors in patients with solid tumors within 8 weeks of treatment start
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments
- Rate of at least one grade improvement without prednisolone using the NCI CTCAE v5.0 [ Time Frame: 2 months ]Clinical benefit of IL-6 inhibition by tocilizumab on diarrhea and/or colitis and/or arthritis induced by checkpoint inhibitors in patients with solid tumors without corticosteroids within 8 weeks of treatment start
- Rate of sustained glucocorticoid-free remission [ Time Frame: 6 months ]Prolonged sustained glucocorticoid-free remission
- Biomarkers [ Time Frame: 6 months ]IL-6, IL-8, IL-17, CD4+ and CD 8+ T cells, Tregs, Th17 T cells, ANA RF, anti-CCP, CRP, WBC, ANC, CD163 and a profile of 90 proteins associated with cancer and inflammation (Olink array), fecal composition of the microflora, imaging changes and inflammation changes in colon if biopsies are available.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601611
|Herlev & Gentofte University Hospital, Denmark|
|Herlev, Denmark, 2730|