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Protocol No. UW18120

Principal Investigator Deming, Dustin

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title My Pathway: An Open-Label Phase IIA Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetnib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response with One of these Agents

Objective Many cancers contain molecular abnormalities (cells show biological and genetic changes in the laboratory) that cause or contribute to their ability to grow and spread. By blocking the effects of these abnormalities, the growth of cancer may be stopped or slowed down. Many new cancer drugs work in this way and because they block the effects of specific molecular abnormalities within the cancer, they are known as “targeted” agents
As more such targets are identified, and more drugs are found to work against them,more patients are now having molecular tests done on their tumor tissue (“molecular profiling”), in order to identify potential molecular targets for treatment
Atezolizumab is an antibody (a protein similar to the ones produced by your body's immune system) that blocks the PD-L1 pathway. The PD-L1 pathway is involved in decreasing your body’s natural immune response to fight cancer. By blocking the PD-L1 pathway, atezolizumab may help your immune system stop or reverse the growth of tumors with elevated TMB

Treatment You will receive treatment with atezolizumab and it will be divided into “cycles” of 21 days duration. The number of cycles you receive will depend on how well your cancer responds to treatment, how well you tolerate treatment, and your overall condition. Atezolizumab will be given intravenously (IV) on Day 1 of each treatment cycle

Description Phase IIA with Atezoliumab in Advanced Solid Tumors

Key Eligibility
  • Age greater than or equal to 18 years
  • Life expectancy greater than or equal to 12 weeks
  • Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
  • Molecular testing results from CLIA-certified laboratories showing at least one of the following abnormalities: HER2 overexpression or amplification, ALK genetic alterations (gene rearrangements, putative activating non-synonymous ALK mutations, ALK copy number gain) and selected alterations in ALK expression, and Elevated tTMB Molecular testing results used for patient eligibility should be obtained from the most recent tumor biopsy. Alternatively and for selected arms, molecular testing results used to determine patient eligibility could have been obtained from a recent blood sample up to 2 months prior to enrollment
  • Patients who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option
  • No previous treatment with the specific assigned study drug or any other drug sharing the same target
  • Measurable disease by RECIST v1.1
  • ECOG PS score of 0 or 1
  • Adequate hematologic, renal and liver function as defined by the protocol
  • Male patients with prostate cancer who are receiving androgen blockade will be eligible for the study
  • Male and female patients of childbearing potential must agree to adequate birth control as defined by the protocol
  • Patients with hematologic malignancies
  • Concurrent administration of any other anti-cancer therapy
  • Bisphosphonates and denosumab are allowed
  • Active or untreated brain metastases
  • History of carcinomatous meningitis
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Any of the following cardiovascular events within 6 months prior to study entry: myocardial infarction, malignant hypertension, severe/unstable angina, symptomatic congestive heart failure, cerebral vascular accident, or transient ischemic attack
  • Pulmonary embolism within 30 days prior to study entry
  • History or presence of clinically significant ventricular or atrial dysrhythmia greater than Grade 2
  • Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park