A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVProstate Cancer
Stage 3
Phase 2
Open to Enrollment
1st Line post recurrence
Radiation +/- apalutamide
Androgen receptor inhibitor
Dan Vaena, MD
NRG Oncology
Adenocarcinoma
- Prostate adenocarcinoma
- Post-prostatectomy (within last 10 years)
- Detectable serum PSA (between 0.1 and 1.0 ng/mL) at study entry
- Any of following
- Gleason score 7-10
- >= T3a disease
- PSA never became undetectable following prostatectomy
- No nodal involvement
- KPS 70-100
- Availability of tissue
- Prior ADT allowed if previously given for <90 days
- GFR >35
- No prior invasive malignancy except in-situ disease, stage I resected melanoma, or disease free for at least 2 years
- No prior chemotherapy for prostate cancer
- No prior radiation that would result in overlap
- No history or predisposition to seizures
- No IBD
- No severe CAD
My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, Endometrial, Uterine, Ovarian, Cervical, Colon, colorectal, biliary, gastric, esophageal, sarcoma, pancreatic, bladder, prostate
Stage 4
Phase 2
Open to Enrollment
2ndline or later
Atezolizumab
PD-L1 inhibitor
Ari VanderWalde, MD
Genentech
Solid tumor
- PD-L1 copy number gain/amplification (likely available on Foundation only)
- Patients with MSI-high
- Using either Foundation 1 or other NGS defined by a shift in the size of 30% or more loci
- Patients with dMMR
- Defined as loss of at least one of four markers (MLH1, MSH2, PMS2, MSH6)
- Patients with total mutational burden (TMB) high
- 10 mut/Mb per any CLIA certified test
- Patients with alterations in DNA proofreading/repair genes
- POLE mutations
- POLD1 mutations
- Mutations in genomic instability genes eg. MSH2, MLH1, MSH6
- If testing was not performed by Foundation Medicine, new pretreatment tissue sample is required. Tissue may be submitted within 4 weeks after enrollment
- No metastatic non-small cell lung cancer (no NSCLC)
- No metastatic urothelial carcinoma (no bladder cancer)
- No MSI-high colorectal cancer
- No history of autoimmune disease or immune deficiency
- No HIV/HBV/HCV
- No other malignancy within 5 years
- No need for immunosuppressive medications (including steroids)
An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification
VIEW TRIAL ON CLINICALTRIALS.GOVBladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma
Stage 4
Phase 2
Open to Enrollment
Any (provided no curative therapy available)
Neratinib
pan-HER TKI
Lee Schwartzberg, MD
Puma Biotechnologies
HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer
- Histologically confirmed cancer for which no curative therapy exists
- Documented HER2 (ERBB2) or HER4 (ERBB4) mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
- Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
- At least one measurable or evaluable lesion
- LVEF >/=50%
- ECOG PS 0-2
- No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
- No symptomatic or unstable brain mets (stable are allowed)
- No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
- No uncontrolled cardiac disease
- No chronic diarrheal disorder