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Celldex initiates phase 1/2 study of varlilumab, Yervoy combination

Celldex Therapeutics has announced the initiation of a phase 1/2 safety pilot and expansion study of the combination of varlilumab and Yervoy for the treatment of stage III or IV metastatic melanoma, according to a company release.

“We believe sophisticated combination approaches centered on immunotherapy hold significant promise for the treatment of cancer and, to this end, are committed to exploring novel combinations across a broad array of mechanisms and indications,” Thomas Davis, MD, executive vice president and chief medical officer of Celldex Therapeutics, said in the release.

The phase 1 study will determine the safety and tolerability of varlilumab at two doses - 0.3 mg/kg and 3 mg/kg - combined with Yervoy (ipilimumab, Bristol-Myers Squibb) at 3 mg/kg administered every 3 weeks, according to the release.

After a recommended dose of varlilumab is determined in phase 1, researchers will compare two cohorts in a phase 2 portion of the study: NY-ESO-1-positive patients vs. NY-ESO-1-negative patients. Patients with tumors that express NY-ESO-1 will receive a 1-mg dose of CDX-1401 every 3 weeks in addition to the combination of varlilumab and ipilimumab, the release stated.

The primary objective for both cohorts in the phase 2 study will be an objective response rate up to 24 weeks using standard, modified World Health Organization response criteria. Secondary objectives will include safety and tolerability, immunogenicity, pharmacokinetics and further assessment of anti-tumor activity, according to the release.

Reference: www.celldex.com.