Immune-Mediated Pathophysiology And Clinical Triage Program
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment.
The usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system) with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause a number of side effects, and it is not known if this is the best or safest treatment.
Hydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition.
The purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable.
This is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be 18 years of age, or older;
Patients must be capable of providing consent to enrolment and treatment.
Patients with a performance status of ECOG 0-2 will be eligible for enrolment (see appendix A).
Patients with histologically confirmed cancer receiving anti-PD1 or anti-PDL1 monoclonal antibody ICI therapy, either alone or in combination with anti-CTLA4 monoclonal antibody ICI therapy who develop CTCAEv5.0 grade ≥2 arthritis or arthralgia that has developed on, or after, ICI therapy and is felt to be treatment related (irAA).
Disqualifiers
History of inflammatory arthritis, including, but not limited to: Rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, Ankylosing spondylitis or other chronic inflammatory arthritis. Note: Patients with a known history of stable osteoarthritis will not be excluded.
Patients with an indication for systemic immunosuppressive medications or corticosteroids. Patients with CTCAEv5.0 grade ≥2 irAE's other than irIAA (ie. colitis, pneumonitis, rash, etc) are not eligible for trial, with the exception of endocrinopathies that are being treated with hormone replacement alone and not systemic immunosuppressive medications or corticosteroids.
Patients weighing < 40 kg.
Patients with G6PD deficiency, porphyria or psoriasis.
Trial design
Design model
Parallel
Treatments tested in this trial
Hydroxychloroquine
DrugHydroxychloroquine 5mg/kg PO daily
Placebo
Other interventionHydroxychloroquine-matching placebo
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Hydroxychloroquine, plus prednisoneExperimental treatment 1 intervention
Group B: Hydroxychloroquine-matching placebo, plus prednisonePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of grade ≥2 Immune-Related Arthritis or Arthralgia
Recurrence will be defined as the development of grade ≥2 irAA in a participant whose symptoms initially improved to grade ≤1. Symptoms will be investigator assessed and graded according to CTCAEv5.0.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Total Steroid Usage
The total cumulative dose of prednisone measured in mg used by the participant. If corticosteroids other than prednisone are used, their equivalent dosage in mg of prednisone will be calculated and used for this analysis.
Time frame
Through study completion, an average of 1 year2
Development of immune related adverse events (irAE's) other than irAA
Defined as the emergence of adverse events that were not present at study baseline that are deemed by the investigator to be related to prior use of immune checkpoint inhibitors. Causality will be investigator assessed and graded according to CTCAEv5.0.
Time frame
Through study completion, an average of 1 year3
Adverse Event
The emergence of new or worsening baseline symptoms, physical findings, or laboratory/imaging abnormalities. Causality to study treatment, immune checkpoint inhibitors, or underlying disease status will be investigator assessed and graded according to CTCAEv5.0.
Time frame
Through study completion, an average of 1 year4
Re-initiation of immune checkpoint inhibitor therapy
The proportion of participants in each study arm that are re-treated with an immune checkpoint inhibitor.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov