Randomized phase 2/3 trial of CpG oligodeoxynucleotide PF-3512676 alone or with dacarbazine for patients with unresectable stage III and IV melanoma
Weber JS et al. - In a trial to assess the objective response rate by Response Evaluation Criteria in Solid Tumors of PF-3512676 alone in 2 doses or in combination with dacarbazine (DTIC) in pts with unresectable stage IIIB/C or stage IV malignant melanoma, with the aim of selecting an arm to take forward to a phase 3 portion of the study, it appears that PF-3512676 at the doses used was generally well tolerated. The modest objective response rates observed in all arms did not warrant continuation to the phase 3 portion of the study. Methods- 184 pts were randomized to 1 of 4 treatments: PF-3512676 10 mg (low dose), at 40 mg (high dose), 40 mg plus DTIC (850 mg/m2), or DTIC (850 mg/m2) alone.
- Pts received PF-3512676 subcutaneously wkly in a 3-wk cycle and received DTIC intravenously on the first wk of the cycle.
Results- Objective response rate (PR or CR, confirmed or unconfirmed) in the 40 mg + DTIC arm was 16% (7 pts) compared with 8% (3 pts) with DTIC alone.
- 1 (2%) pt in the 10-mg and 0 pts in the 40-mg arms achieved an objective response.
- Best response of CR or PR or stable disease (SD), with no minimum duration defined for SD, was achieved by 15 (33%) pts in the 40 mg + DTIC arm, 15 (38%) pts in the DTIC-only arm, 8 (17%) pts in the 10-mg arm, and 9 (20%) pts in the 40-mg arm.
- The most frequently reported adverse events were classified as local injection site reactions or systemic flu-like symptoms, specifically fatigue, rigors, and pyrexia.
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