Protocol Summary

Protocol No.: OCR15512

Sponsor Protocol No.: CA018003; Fraction

Study Title
A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants With Advanced Gastric Cancer (FRACTION-Gastric Cancer)

Principal Investigator(s)
George, Thomas

Objective
The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.

Phase: Phase II (Cancer Control)

Age Group: Adult

Scope: National

Treatment
Comparator: Nivolumab and Ipilimumab Combination

Experimental: Nivolumab and BMS-986016 Combination

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years-old and older
2. Advanced Gastric Cancer
3. Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
4. Must have at least 1 lesion with measurable disease

EXCLUSION CRITERIA:
1. Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment
2. Must not have suspected or known central nervous system metastases unless adequately treated
3. Patients/subjects with autoimmune disease
4. Patients/subjects who need daily oxygen therapy

**Other protocol defined inclusion/exclusion criteria could apply

Applicable Disease Sites
Gastrointestinal Cancer

Participating Institutions
UF Gainesville : Twanda Robinson

Contact
Twanda Robinson, RN
Phone: +1 352-273-9489

Email: twanda.robinson@medicine.ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02935634