Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

• ClinicalTrials.gov Identifier: NCT02864381
• Recruitment Status: Completed
• First Posted: August 12, 2016
• Last Update Posted: October 4, 2019
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

Study Description

Brief Summary:

The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Condition or disease	Intervention/treatment	Phase
Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma	Drug: Andecaliximab; Drug: Nivolumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: November 8, 2017
• Actual Study Completion Date: August 23, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Andecaliximab+nivolumab; Andecaliximab+ nivolumab for up to 2 years	Drug: Andecaliximab; 800 mg administered via intravenous (IV) infusion every 2 weeks; Other Name: GS-5745; Drug: Nivolumab; 3 mg/kg administered via intravenous (IV) infusion every 2 weeks
Experimental: Nivolumab; Nivolumab for up to 2 years	Drug: Nivolumab; 3 mg/kg administered via intravenous (IV) infusion every 2 weeks

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate [ Time Frame: Up to 2 years ]
   Objective response rate will be determined from the participants' best response during treatment.

Secondary Outcome Measures :

1. Progression Free Survival [ Time Frame: Up to 2 years ]
   Progression free survival is defined as the interval from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
2. Overall Survival [ Time Frame: Up to 5 years ]
   Overall survival is defined as the interval from date of randomization to death from any cause.
3. Duration of Response [ Time Frame: Up to 2 years ]
   Duration of response is defined as the interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
4. Occurrence of Adverse Events and Laboratory Abnormalities During Treatment [ Time Frame: Up to 2 years ]
   The occurrence of adverse events and laboratory abnormalities will be presented as the percentage of participants who experience treatment-emergent adverse events or treatment-emergent laboratory abnormalities.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

• 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
• Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1
• Measurable disease according to RECIST v1.1
• Tumor sites that can be accessed for repeat biopsies
• Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a PD-L1 stratification test, as assessed by central pathologist
• Individuals 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)
• Required baseline laboratory data as outlined in protocol

Key Exclusion Criteria:

• Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
• Radiotherapy within 28 days of randomization
• Uncontrolled intercurrent illness as outlined in protocol
• History of a concurrent or second malignancy except for those outlined in protocol
• Major surgery, within 28 days of first dose of study drug
• Known positive status for human immunodeficiency virus (HIV)
• Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Chronic daily treatment with oral corticosteroids (dose of > 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
• Known or suspected central nervous system metastases
• Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization
• Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
• Current or history of pneumonitis or interstitial lung disease
• Active known or suspected autoimmune disease with exceptions noted in protocol.
• History of bone marrow, stem cell, or allogenic organ transplantation

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations

  Show 34 Study Locations

Sponsors and Collaborators

Gilead Sciences

Investigators

• Study Director: Gilead Study Director; Gilead Sciences

More Information

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02864381 History of Changes
• Other Study ID Numbers: GS-US-296-2013; 2016-001402-41 ( EudraCT Number )
• First Posted: August 12, 2016
• Last Update Posted: October 4, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Adenocarcinoma; Esophageal Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Nivolumab; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs