A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined with Nivolumab versus Nivolumab Alone in Subjects with Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

Gilead Sciences, Inc0 sites120 target enrollmentAugust 29, 2016

DrugsOPDIVO 10 mg/mL concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Gilead Sciences, Inc
Enrollment: 120
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 29, 2016

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Gilead Sciences, Inc

Eligibility Criteria

Inclusion Criteria

•1\) Age \=18 years
•2\) Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or GEJ which have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease
•3\) Eastern Cooperative Oncology Group (ECOG) \= 1
•4\) Measurable disease according to RECIST v1\.1
•5\) Tumor sites that can be accessed for repeat biopsies
•6\) Archival tumor tissue, preferably from the most recent available biopsy; there must be adequate tissue for a PD\-L1 stratification test, as assessed by central pathologist
•7\) All toxicities attributed to prior anti\-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4\) or baseline
•8\) Subjects not receiving anticoagulant medication must have an international normalized ratio (INR) \= 1\.5 and activated partial thromboplastin (aPTT) \= 1\.5 x upper limit of normal (ULN). The use of full\-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the subject has been on stable dose of anticoagulants for at least 1 week at the time of randomization
•9\) Adequate hematologic function
•a) neutrophils \= 1\.5 x 10^9/L

Exclusion Criteria

•1\) Subjects who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
•2\) Radiotherapy within 28 days of randomization; subjects given palliative radiotherapy to peripheral sites (eg, bone metastasis) may enter the study before 28 days have elapsed provided the radiated sites do not contain lesions which may be used to evaluate response, and must have recovered from any acute, reversible effects
•3\) Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, active gastrointestinal bleeding, uncontrolled cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician
•4\) History of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer without known metastatic disease, with no requirement for therapy or requiring only hormonal therapy, and with normal prostate\-specific antigen for \= 1 year prior to randomization; adequately treated Stage 1 or 2 cancer currently in complete remission; or any other cancer that has been in complete remission for \= 5 years
•5\) Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy), within 28 days of first dose of study drug
•6\) Known positive status for human immunodeficiency virus (HIV)
•7\) Known acute or chronic\-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
•8\) Chronic daily treatment with oral corticosteroids (dose of \> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled steroids and short courses of oral steroids for anti\-emesis or as an appetite stimulant are allowed
•9\) Known or suspected central nervous system metastases
•10\) Known alcohol or drug abuse or any other medical or psychiatric condition which contraindicates participation in the study