The Trials in Progress Poster Session (TPS) at the ASCO Annual Meeting, now in its third year, is intended to stimulate discussion in the oncology community about ongoing clinical trials and to promote collaboration. The following is a roundup of TPS abstracts covering a broad range of cancer types.
Cabazitaxel versus standard treatment for metastatic castration-resistant prostate cancer
This phase III study will test whether first-line cabazitaxel in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) is superior to docetaxel (D). Both treatment groups will receive concurrent prednisone. Cabazitaxel is a novel taxane active in D-sensitive and D-resistant tumor models. Docetaxel/prednisone as first-line chemotherapy in patients with mCRPC is the current standard of care; however, treatment is not curative, and D-resistant disease typically develops. Patients with ECOG performance status of 0-2, histologically/cytologically confirmed metastatic prostate adenocarcinoma with no prior chemotherapy and with disease progression following medical or surgical castration are eligible. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), radiologic PFS, tumor response in measurable disease, prostate-specific antigen (PSA) response and PSA PFS, pain response and pain PFS, time to occurrence of any skeletal-related events, safety profile, and health-related quality of life. Cabazitaxel pharmacokinetics and pharmacogenomics will be assessed in patient subgroups. Abstract TPS4696.Sponsor: Sanofi
ClinicalTrials.gov Identifier: NCT01308567Neoadjuvant MDV3100 for prostate cancer
This phase II study will test the effect of neoadjuvant androgen receptor (AR) blockade with AR inhibition alone using MDV3100 or combined with maximal suppression of androgens involving MDV3100 plus leuprolide and dutasteride. MDV3100 is a potent AR-signaling inhibitor that inhibits AR signaling via three mechanisms: inhibition of androgen binding to AR, inhibition of AR nuclear translocation, and inhibition of nuclear AR-DNA binding. The study population includes men with treatment-naïve, localized prostate cancer who are candidates for radical prostatectomy and have either a PSA greater than 10 ng/mL or Gleason score of 7 (4 + 3) or higher with 3 or more cores containing tumor and no evidence of metastatic/nodal disease. All patients receive MDV3100 (160 mg/day orally); those randomized to MDV3100 plus leuprolide and dutasteride therapy also receive leuprolide (22.5 mg IM every 3 months) and dutasteride (0.5 mg/day orally). The primary efficacy endpoint is pathological complete response rate at the time of radical prostatectomy. Abstract TPS4695.Sponsor: Medivation; Astellas Pharma
ClinicalTrials.gov Identifier: NCT01547299
ICTâ€‘107 for glioblastoma multiforme after resection and chemoradiation
This phase II study will test the efficacy and safety of ICT-107 in patients with newly diagnosed glioblastoma multiforme (GBM) who have undergone complete surgical resection or have minimal residual tumor <1 cm3, and are HLA-A1– and/or HLA-A2–positive. In order to be eligible for enrollment, patients must also have a Karnofsky performance status ≥70% and adequate hematologic and chemistry parameters. ICTâ€‘107 is an autologous vaccine consisting of the patient’s dendritic cells pulsed with six synthetic peptide CTL epitopes targeting the GBM tumor and tumor stem cell–associated antigens MAGEâ€‘1, HER2, AIMâ€‘2, TRPâ€‘2, gp100, and ILâ€‘13Rα2. The primary endpoint is OS. Secondary endpoints include PFS, rates of OS and PFS at 6 months after surgery and every 3 months thereafter, safety and tolerability of ICTâ€‘107, immune response to ICT-107, and predictors of response. Approximately 200 patients are expected to be enrolled for screening. Abstract TPS2107.Sponsor: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT01280552
Afatinib or trastuzumab with vinorelbine for metastatic breast cancer