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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02864381




Registration number
NCT02864381
Ethics application status
Date submitted
10/08/2016
Date registered
12/08/2016
Date last updated
18/09/2020

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
Scientific 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
Secondary ID [1] 0 0
2016-001402-41
Secondary ID [2] 0 0
GS-US-296-2013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Adenocarcinoma 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Andecaliximab
Treatment: Drugs - Nivolumab

Experimental: Andecaliximab + Nivolumab - Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).

Active Comparator: Nivolumab - Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).


Treatment: Drugs: Andecaliximab
800 mg administered via IV infusion

Treatment: Drugs: Nivolumab
3 mg/kg administered via IV infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) - ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Timepoint [1] 0 0
Up to 41 weeks
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date.
Timepoint [1] 0 0
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Secondary outcome [2] 0 0
Overall Survival (OS) - OS was defined as the interval from the date of randomization to death from any cause. Surviving participants are censored at the last date known alive.
Timepoint [2] 0 0
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months
Secondary outcome [3] 0 0
Duration of Response (DOR) - DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
Timepoint [3] 0 0
Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months
Secondary outcome [4] 0 0
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) - An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab.
Timepoint [4] 0 0
Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months
Secondary outcome [5] 0 0
Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities - Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported.
Timepoint [5] 0 0
Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months

Eligibility
Key inclusion criteria
Key

- 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 Response Criteria in Solid Tumors (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 Cochran-Mantel Haenszel (CMH) test stratified by
programmed death ligand 1 (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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 0 0
- Albury
Recruitment hospital [2] 0 0
- Wahroonga
Recruitment hospital [3] 0 0
- Douglas
Recruitment hospital [4] 0 0
- Hobart
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2076 - Wahroonga
Recruitment postcode(s) [3] 0 0
4818 - Douglas
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
Belgium
State/province [6] 0 0
Hainaut
Country [7] 0 0
Belgium
State/province [7] 0 0
Oost-Vlaanderen
Country [8] 0 0
Belgium
State/province [8] 0 0
Vlaams Brabant
Country [9] 0 0
France
State/province [9] 0 0
Finistère
Country [10] 0 0
France
State/province [10] 0 0
Marne
Country [11] 0 0
France
State/province [11] 0 0
Val-de-Marne
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Debrecen
Country [14] 0 0
Italy
State/province [14] 0 0
Forli-Cesena
Country [15] 0 0
Italy
State/province [15] 0 0
Ligura
Country [16] 0 0
Italy
State/province [16] 0 0
Lombardia
Country [17] 0 0
Italy
State/province [17] 0 0
Toscana
Country [18] 0 0
Poland
State/province [18] 0 0
Podkarpackie
Country [19] 0 0
Poland
State/province [19] 0 0
Poznan
Country [20] 0 0
Poland
State/province [20] 0 0
Warszawa
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Bristol
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Edgbaston
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02864381
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications