TriCalm Hydrogel for the Treatment of Immunotherapy-Related Pruritus

Status: active

This phase II trial tests how well TriCalm Hydrogel® works in treating pruritus (itching) caused by immunotherapy in patients with cancer. Pruritus is a common immune-related adverse event in patients who receive immune checkpoint inhibitors (ICIs) and impacts quality of life. Management of immunotherapy-related pruritus primarily involves topical moisturizers, topical steroids and/or systemic antihistamines. TriCalm Hydrogel is a topical gel containing strontium chloride, as an antipruritic (anti-itch) therapy in relieving immunotherapy-related pruritus. Using TriCalm Hydrogel may help relieve pruritus caused by immunotherapy in patients with cancer.

Inclusion Criteria

Patients aged 18 years or older.
Patients receiving ICIs for hematologic or oncologic malignancies at the Moores Cancer Center Infusion Center at University of California (UC) San Diego. ICIs include CTLA-4 inhibitors (ipilimumab), PD-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab, avelumab, durvalumab).
Patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ICI.
Preexisting use of oral antihistamines and/or gamma aminobutyric acid (GABA) analogs more than 7 days prior to study entry are allowed.

Exclusion Criteria

Diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis).
Initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry.
Presence of open wounds on the skin.
Presence of pruritus on the face.

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of TriCalm Hydrogel in reducing the severity of immunotherapy-related pruritus.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of TriCalm Hydrogel in improving the quality of life in patients with immunotherapy-related pruritus.

II. To evaluate the safety of TriCalm Hydrogel in patients with immunotherapy-related pruritus.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients apply TriCalm Hydrogel topically to skin as needed on days 1-21 or 28 of cycles 1 and 2. Cycles repeat every 3-4 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients apply triamcinolone cream topically to skin up to twice daily (BID) as needed on days 1-21 or 28 of cycle 1. Patients then switch to TriCalm Hydrogel as needed on days 1-21 or 28 for cycle 2. Cycles repeat every 3-4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment/intervention, patients/participants are followed up at 30 days.

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TriCalm Hydrogel for the Treatment of Immunotherapy-Related Pruritus

Inclusion Criteria

Exclusion Criteria

United States

California

La Jolla

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TriCalm Hydrogel for the Treatment of Immunotherapy-Related Pruritus

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