Last updated on July 2020

Study of ARRY-614 Plus Either Nivolumab or Ipilimumab


Brief description of study

In this study, the Phase Ib portion aims to establish safety and tolerability of ARRY-614 with either nivolumab or ipilimumab and to determine a recommended phase II dose of ARRY-614 in combination with either nivolumab or ipilimumab immunotherapy in patients with selected advanced solid tumors. The Phase II portion will estimate the efficacy of ARRY-614 in combination with either nivolumab or ipilimumab immunotherapy in patients with melanoma and renal cell carcinoma.

Detailed Study Description

In the Phase lb portion of the trial: Participants must have a histologically confirmed malignancy that is metastatic or unresectable for which standard curative or palliative measures do not exist or are no longer effective. Melanoma trial participants must have either nivolumab or ipilimumab available and have progressed on anti-PD1 or anti-PD1/anti-CTLA4 combination therapy. Other advanced solid tumor trial participants must have nivolumab or therapy available and must be appropriate for this therapy. In the Phase ll portion of the trial: Participants with melanoma who previously experienced disease progression on anti-PD1 may enter the ARRY-614 plus nivolumab cohort or the ARRY-614 plus ipilimumab cohort. Participants with melanoma entering the ARRY-614 plus ipilimumab cohort must be nave to ipilimumab therapy. Participants with RCC who previously experienced disease progression on anti-PD1 may enter the ARRY-614 plus nivolumab cohort. Potential participants will undergo Screening Procedures to determine eligibility within 28 days prior to the start of study treatment on Cycle 1, Day 1 (C1D1). Results of standard of care tests or examinations performed prior to obtaining informed consent and within 21 days prior to Cycle 1 Day 1 may be used for screening assessments rather than repeating such tests. The first 5 patients in each Phase II arm will undergo pre and on-treatment biopsies. The second biopsy will occur at C2D1 7 days.Participants who meet all study eligibility criteria will be eligible to start study treatment. Patients will receive ARRY-614 on a QD continuous schedule. One cycle is defined as 4 weeks (28 days) 3 days. Prescribed QD doses should be taken at consistent times each day, as close to 24 2 hours apart as possible. Daily study treatment will begin on C1D1 with planned concurrent dosing of ARRY-614 and either nivolumab or ipilimumab. Upon determination of the Recommend Phase ll Doseof ARRY-614, a similar dosing schedule will be pursued. Three simultaneous phase II, tumor-specific trials will be conducted: melanoma with nivolumab, melanoma with ipilimumab, and RCC with nivolumab. ARRY-614 will be given on a daily PO schedule in 4-week cycles ( 3 days). Nivolumab and ipilimumab will be given according to the corresponding FDA label dosing schedule for each individual agent.

Clinical Study Identifier: NCT04074967

Find a site near you

Start Over

UPMC Hillman Cancer Center

Pittsburgh, PA United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.