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news.Celldex Therapeutics and Pfizer have announced plans to amend the ongoing ACT III clinical trial involving the investigational compound, CDX-110.
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ACT III is a randomized open-label, two-arm, Phase IIb/III trial comparing CDX-110 combined with temozolomide to temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM). Only the Phase IIb portion of the trial has been open to enrollment.
This amendment is expected to convert ACT III to a single-arm Phase II clinical trial in which all patients will receive the study medication, CDX-110, in combination with temozolomide, and will continue to enroll to approximately 60 patients.
The companies’ decision to amend the ACT III clinical trial, which follows the recommendation of the Independent Data Monitoring Committee, was based on the observation that the majority of patients randomized to the control arm withdrew from this open-label study after being randomized to the control arm. Patients currently participating on the control arm of the study will be offered the option to receive treatment with CDX-110.
Under this amendment, the ACT III study is expected to provide a multi-center non-randomized data set for CDX-110 in patients with newly diagnosed GBM. These data will provide additional information on the overall clinical profile for the development of CDX-110.