In This Section      
 

Search Results

Title:
J17107 - A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Hormone Receptor-Positive Her2-Negative Breast Cancer (Morpheus-HR+ Breast Cancer)
Protocol Number:
J17107
Phase:
Phase I/II
Physician:
Cesar Santa-Maria
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To Evaluate The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations
Eligibility:
Patients with HR +, HER2 neg, MBC or LABC who have had progression on first line CDK 4/6 inhibitor.PS of 0-2 No prior Fulvestrant allowed. Post-menopausal (LHRH agonist allowed). RECIST measurable and biopsiable disease. No prior chemo for MBC. No prior PDL 1/PD1 allowed. No autoimmune. LVEF greater than 50. No retinal disorders. No insulin dependent diabetes. No malabsorption syndromes.
Treatment:
The study is being conducted in two stages. During Stage 1, patients will be randomized to fulvestrant or an Atezolizumab-containing doublet or triplet combination. Those who experience progression/toxicity may be eligible to receive a new triplet combination treatment in Stage 2. Patients will be randomized to the following treatment arms:Safety Run In- 6 patients: Ipatasertib + Atezolizumab (no randomization)Arm 1: FulvestrantArm 2: Atezolizumab + Cobimetinib Arm 3: Atezolizumab + FulvestrantArm 4: Atezolizumab + IpatasertibArm 5: Atezolizumab + Ipatasertib + FulvestrantCrossover Arm (Stage 2): Atezolizumab + Bevacizumab + Endocrine TherapyExpansion phase: Mandatory biopsy cohort: Atezolizumab+ +Cobimetinib +Fulvestrant + IpatasertibStudy requires: Archival tissue available, on treatment biopsies, Research blood samples, Ophthalmology exams, and echocardiograms. If on mandatory biopsy cohort requires up to 3-4 biopsies.
Population:
Adult
Last Update
12/14/2019 05:03 AM