Open Clinical Trials

Breast Cancer Studies:

– HER2 positive unresectable and/or metastatic breast cancer with prior HER2 therapies including T-DM1. A phase 3 trial with an anti-HER2-Antibody drug conjugate versus treatment of investigators choice. (DS8201-A-U301)

-HER negative ER/PR positive locally advanced or metastatic. Previous tx w/taxane in neo adj or adjuvant, but not metastatic. Any number of previous hormonal therapies allowed.  Arm A= Tesetaxel plus a reduced dose of Capecitabine (825 mg/ m2) orally twice daily. Arm B= Approved dose of Capecitabine alone. (Odonate ODO-TE-B301)

-HER positive mBC who have received prior treatment with Herceptin and Perjeta and T-DM1 (substudy). Chemo = choice of Capecitabine, eribulin, gemcitabine or vinorelbine. Infusion sub study= Margetuximab monotherapy vs Margetuximab + Chemo. Decreased infusion time from 120 to 30 minutes. Will require ≥4 prior lines (including trastuzumab, pertuzumab and T-DM1). (SOPHIA CP-MGAH22-04)

For questions regarding this study, please contact 480-398-7671

Lung Studies:

-NSCLC – 2nd or 3rd line chemotherapy for NSCLC with at least 1 lung lesion ≥ 10mm. Single-blinded study (investigators know the treatment arm, the patient does NOT). Experimental Arm: Plinabulin (30 mg/m2)+ Docetaxel (75 mg/m2).  Control Arm: Placebo + Docetaxel (75 mg/m2).  (DUBLIN-3) (BPI-2358-103)

-Device study NSCLC- Stage 4 Progression after platinum failure. No current device in thorax. (TTFields) concurrent with a standard of care therapies. Arm 1: docetaxel or immune checkpoint inhibitors Alone. Arm 2: docetaxel or immune checkpoint inhibitors + TTFields.  TTFields application will be continuous with for at least 18 hours a day on Average.  (LUNAR EF-24).

For questions regarding this study, please contact 480-398-7671

Melanoma Studies:

-Advanced Melanoma with previous anti-PD-1/ L1 treatment Phase 2 trial with lenvatinib in combination with pembrolizumab (LEAP-004).

For questions, please contact 480-398-7671

Lymphoma Studies:

-Relapsed or refractory NHL –including FL, SLL, Marginal zone and DLBCL  previously treated, AND non-candidates for high dose chemo or transplant. FL stage 2: Arm A: Ublituximab + TGR-1202 Arm B: TGR-1202 Monotherapy  Arm D: Ublituximab monotherapy  MCL stage 2: Ublituximab + TGR-1202 (UNITY-NHL-205 UTX-TGR-205).

-Relapsed iNHL Or progressed after 1 or at most 3 lines including rituximab-based and alkylating agents. FL, SLL, LPL, WM, MZL. Randomized 1:1 Arm 1: Copanlisib/placebo plus R-Bendamustine  X6 cycles followed by Copanlisib/placebo maintenance. After run-in is completed, will open to add Copanlisib/placebo + R-CHOP arm.  ( Chronos-4).

For questions regarding this study, please contact 480-398-7671

Registry Studies:

NSCLC Registry of Guardant360® use and outcomes. No more than 8 wks from blood collection. Advanced NSCLC or stage I-IIIA, that is recurrent or metastatic. Collect information on how the results from the Guardant360 test affect clinical decisions. Also understanding the outcomes associated with therapies selected for patients whose tumors have specific genetic mutations. (Geode 01-MX-003)

For questions regarding this study, please contact 480-398-7671

Colorectal Studies:

-2nd line Metastatic Colorectal Cancer Previously Treated with Fluoropyrimidine / Oxaliplatin and Bevacizumab. Patients will be stratified according to the subjects’ RAS mutation status and tumor location. Experimental Arm: ABT-165 + FOLFIRI ABT-165, 2.5 mg/kg, plus FOLFIRI Control Arm: Bevacizumab + FOLFIRI bevacizumab, 5 mg/kg, plus FOLFIRI (Abbvie M14-064)

For questions regarding this study, please contact 480-398-7671

Enrollment Currently On Hold:

MELANOMA– post-resection treatment of Stage IIB, IIC, or III cutaneous disease. Enrollment in part B2 to begin approx. Q1 2018 1:1 randomization POL-103A (polyvalent vaccine) or placebo.  Schedule: q2weeks X 4, then monthly X4, then q3months through 24 months. (MAVIS)

Advanced triple neg. Breast -Progressed after adjuvant or 1 prior line. -Prior taxane required. -No prior anti PD-L1, anti-LAG-3 etc. -No prior Platinum tx.  Arm 1: LAG525(400mg) + Spartalizumab (300mg) Arm 2: LAG525 + Spartalizumab + carboplatin Arm 3: LAG525 +Carboplatin