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Gastric AdenocarcinomaPhase 2NCT02864381

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

A Phase 2 study testing Andecaliximab and Nivolumab in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Gilead Sciences at 34 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Andecaliximab and Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
34 sitesin 9 countries
Study dates
1 Sep 2016to 23 Aug 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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.

Trial locations and contacts

34 sites in 9 countries.

34 sites in 9 countries

United States6 sites

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Fort Wayne, Indiana, 46845

  • Study site

    Los Angeles, California, 90095

  • Study site

    New York, New York, 10065

  • Study site

    San Francisco, California, 94158

  • Study site

    St Louis, Missouri, 63110

Other trials in United States

United Kingdom6 sites

  • Study site

    Bristol, BS2 8ED

  • Study site

    Edgbaston, B15 2PR

  • Study site

    London, EC1A 7BE

  • Study site

    London, WC1E 6BT

  • Study site

    Manchester, M20 4BX

  • Study site

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia4 sites

  • Study site

    Albury, New South Wales, 2640

  • Study site

    Douglas, Queensland, 4818

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Wahroonga, New South Wales, 2076

Other trials in Australia

Italy4 sites

  • Study site

    Genova, Ligura, 16128

  • Study site

    Meldola, Forli-Cesena, 47014

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Pisa, Tuscany, 56126

Other trials in Italy

Belgium3 sites

  • Study site

    Ghent, Oost-Vlaanderen, 9000

  • Study site

    La Louvière, Hainaut, 7100

  • Study site

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

France3 sites

  • Study site

    Brest, Finistère, 29609

  • Study site

    Reims, Marne, 51092

  • Study site

    Villejuif, Val-de-Marne, 94805

Other trials in France

Poland3 sites

  • Study site

    Brzozów, Podkarpackie Voivodeship, 36-200

  • Study site

    Poznan, 60-693

  • Study site

    Warsaw, 02-781

Other trials in Poland

Spain3 sites

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, 08003

  • Study site

    Majadahonda, Madrid, 28222

Other trials in Spain

Hungary2 sites

  • Study site

    Budapest, H-1097

  • Study site

    Debrecen, 4032

Other trials in Hungary

About this study

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

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.

Being tested
Andecaliximab, Nivolumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AndecaliximabDrug

    Also called GS-5745

    800 mg administered via IV infusion

  • NivolumabDrug

    3 mg/kg administered via IV infusion

Study groups in NCT02864381
Study groupRoleWhat they receive
Andecaliximab + NivolumabExperimentalAndecaliximab 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).
Receives: Drug: Andecaliximab; Drug: Nivolumab
NivolumabActive comparatorNivolumab 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).
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 41 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months

  2. 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.

    Measured: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months

  3. 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.

    Measured: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion8 Nov 2017
  4. Study completion23 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02864381
Sponsor's protocol ID
GS-US-296-2013
Other IDs
2016-001402-41, 2016
Status last verified
Sep 2020
First submitted
10 Aug 2016
Last updated
18 Sep 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shah MA, Cunningham D, Metges JP, Van Cutsem E, Wainberg Z, Elboudwarej E, Lin KW, Turner S, Zavodovskaya M, Inzunza D, Liu J, Patterson SD, Zhou J, He J, Thai D, Bhargava P, Brachmann CB, Cantenacci DVT. Randomized, open-label, phase 2 study of andecaliximab plus nivolumab versus nivolumab alone in advanced gastric cancer identifies biomarkers associated with survival. J Immunother Cancer. 2021 Dec;9(12):e003580. doi: 10.1136/jitc-2021-003580.

    PubMed 34893523

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Andecaliximab and Nivolumab in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Gilead Sciences at 34 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, United Kingdom, Australia, Italy, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 41 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864381, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

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