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Gastric CancerPhase 2NCT03662659

An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

A Phase 2 study testing BMS-986213, Nivolumab and XELOX in people with Gastric Cancer and Cancer of the Stomach, run by Bristol-Myers Squibb at 79 sites in 17 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMS-986213, Nivolumab and XELOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
79 sitesin 17 countries
Study dates
16 Oct 2018to 18 Jan 2024
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

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
  • No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
  • Tumor tissue must be provided for biomarker analyses

Who cannot join

  • Participants with HER2 positive status
  • Participants with known untreated central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

79 sites in 17 countries.

79 sites in 17 countries

United States13 sites

  • Local Institution - 0056

    Aurora, Colorado, 80045

  • Local Institution - 0049

    Clovis, California, 93611

  • Local Institution - 0054

    Dallas, Texas, 75216

  • Local Institution - 0064

    Duarte, California, 91010-3012

  • Local Institution - 0050

    Hackensack, New Jersey, 07601

  • Scripps Clinic

    La Jolla, California, 92037

  • Local Institution - 0040

    Los Angeles, California, 90033

  • Local Institution - 0062

    New Haven, Connecticut, 06520

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Local Institution - 0041

    Orange, California, 92868

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Local Institution - 0077

    Santa Monica, California, 90404

  • Local Institution - 0052

    Seattle, Washington, 98109

Other trials in United States

Germany10 sites

  • Local Institution - 0083

    Cologne, 50937

  • Local Institution - 0082

    Dresden, 01307

  • Local Institution - 0017

    Essen, 45136

  • Local Institution - 0081

    Essen, 45147

  • Local Institution - 0014

    Frankfurt, 60488

  • Local Institution - 0018

    Hamburg, 20249

  • Local Institution - 0012

    Hanover, 30625

  • Local Institution - 0013

    Heidelberg, 69120

  • Local Institution - 0015

    Mannheim, 68167

  • Local Institution - 0016

    Marburg, 35043

Other trials in Germany

Australia7 sites

  • Local Institution - 0028

    Bedford Park, 5024

  • Local Institution - 0003

    Heidelberg, Victoria, 3084

  • Local Institution - 0007

    Herston, Queensland, 4029

  • Local Institution - 0029

    Malvern, Victoria, 3144

  • Local Institution - 0005

    Murdoch, Western Australia, 6150

  • Local Institution - 0008

    Shepparton, Victoria, 3630

  • Local Institution - 0027

    Westmead, New South Wales, 2145

Other trials in Australia

France7 sites

  • Local Institution - 0047

    Avignon, 84918

  • Local Institution - 0073

    Besançon, 25030

  • Local Institution - 0045

    Dijon, 21000

  • Local Institution - 0071

    Montpellier, 34090

  • Local Institution - 0043

    Paris, 75010

  • Local Institution - 0072

    Paris, 75012

  • Local Institution - 0046

    Rouen, 76031

Other trials in France

Spain7 sites

  • Local Institution - 0099

    Badajoz, 06080

  • Local Institution - 0098

    Barcelona, 08035

  • Local Institution - 0061

    Barcelona, 08036

  • Local Institution - 0059

    Bilbao, 48013

  • Local Institution - 0058

    Madrid, M, 28046

  • Local Institution - 0057

    Madrid, 28007

  • Local Institution - 0060

    Zaragoza, 50009

Other trials in Spain

United Kingdom7 sites

  • Local Institution - 0032

    Coventry, West Midlands, CV2 2DX

  • Local Institution - 0036

    Lancaster, LA1 4RP

  • Local Institution - 0034

    London, SE1 9RT

  • Local Institution - 0075

    Manchester, Greater Manchester, M20 4BX

  • Local Institution - 0069

    Northwood, HA6 2RN

  • Local Institution - 0035

    Nottingham, Nottinghamshire, NG5 1PB

  • Local Institution - 0033

    Southampton, SO16 6YD

Other trials in United Kingdom

Canada5 sites

  • Local Institution - 0063

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 0024

    Kelowna, British Columbia, V1Y 5L3

  • Local Institution - 0095

    Québec, Quebec, G1R 2J6

  • Local Institution - 0070

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0055

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Argentina4 sites

  • Local Institution - 0009

    Buenos Aires, Buenos Aires F.D., C1093AAS

  • Local Institution - 0078

    CABA, 1426

  • Local Institution - 0010

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

  • Local Institution - 0011

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Chile4 sites

  • Local Institution - 0002

    Rancagua, L.g.bernardoohiggins, 0

  • Local Institution - 0080

    Santiago, Santiago Metropolitan

  • Local Institution - 0079

    Santiago, 0

  • Local Institution - 0001

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Italy3 sites

  • Local Institution - 0020

    Milan, 20132

  • IRCCS Istituto Nazionale Tumori Milano

    Milan, 20133

  • Local Institution - 0021

    Roma, 00168

Other trials in Italy

Norway3 sites

  • Local Institution - 0088

    Bergen, 5021

  • Local Institution - 0086

    Oslo, 0450

  • Local Institution - 0087

    Trondheim, 7030

Other trials in Norway

Austria2 sites

  • Local Institution - 0090

    Graz, 8036

  • Local Institution - 0089

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Local Institution - 0091

    Brussels, 1200

  • Local Institution - 0092

    Leuven, 3000

Other trials in Belgium

Czechia2 sites

  • Local Institution - 0031

    Brno, 656 53

  • Local Institution - 0030

    Olomouc, 779 00

Other trials in Czechia

Poland1 site

  • Local Institution - 0093

    Warsaw, 02-034

Other trials in Poland

Puerto Rico1 site

  • Local Institution - 0067

    San Juan, 00927

Other trials in Puerto Rico

Singapore1 site

  • Local Institution - 0038

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

Being tested
BMS-986213, Nivolumab, XELOX, FOLFOX, SOX
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • BMS-986213Biological

    Relatlimab + Nivolumab specified dose on specified days

  • NivolumabBiological

    Also called Opdivo, BMS-936558

    Specified dose on specified days

  • XELOXDrug

    Oxaliplatin + capecitabine

  • FOLFOXDrug

    Oxaliplatin + leucovorin + fluorouracil

  • SOXDrug

    Oxaliplatin + tegafur/gimeracil/oteracil potassium

Study groups in NCT03662659
Study groupRoleWhat they receive
BMS-986213 + investigator's choice chemotherapyExperimentalBMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
Receives: Biological: BMS-986213; Biological: Nivolumab; Drug: XELOX; Drug: FOLFOX; Drug: SOX
Nivolumab + investigator's choice chemotherapyExperimentalNivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
Receives: Biological: Nivolumab; Drug: XELOX; Drug: FOLFOX; Drug: SOX

What is being measured

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

  1. BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants

    The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

    Measured: Up to 25 months

  2. BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection

    The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

  2. Duration of Response (DOR)

    Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented complete response (CR) or partial response (PR) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.

    CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions

    Measured: From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

  3. Overall Survival (OS)

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.

    Measured: From the date of randomization to the date of death due to any cause (Up to 63 months)

  4. Progression-Free Survival (PFS)

    Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.

    Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)

  5. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires inpatient hospitalization, results in significant disability, is a birth defect, or is an important medical event.

    Measured: From first dose to 30 days post last dose (Up to 60 months)

  6. Number of Participants Who Died

    Number of participants who died in each arm.

    Measured: Up to 60 months

  7. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

    Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

    • ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
    • Total bilirubin > 2 x ULN
    • ALP > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
    • Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
    • Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN

    Measured: From first dose to 30 days post last dose (Up to 60 months)

  8. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:

    • TSH value > ULN and
    • with baseline TSH value <= ULN
    • with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test.
    • TSH < LLN and
    • with baseline TSH value >= LLN
    • with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
    • with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
    • with FT3/FT4 missing within 2-week window after the abnormal TSH test

    Measured: From first dose to 30 days post last dose (Up to 60 months)

Timeline

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

  1. First posted7 Sep 2018
  2. Study start16 Oct 2018
  3. Primary completion27 Aug 2020
  4. Study completion18 Jan 2024

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
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662659
Sponsor's protocol ID
CA224-060
Other IDs
2018-001069-18, 2018
Status last verified
Jan 2025
First submitted
6 Sep 2018
Last updated
5 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hegewisch-Becker S, Mendez G, Chao J, Nemecek R, Feeney K, Van Cutsem E, Al-Batran SE, Mansoor W, Maisey N, Pazo Cid R, Burge M, Perez-Callejo D, Hipkin RW, Mukherjee S, Lei M, Tang H, Suryawanshi S, Kelly RJ, Tebbutt NC. First-Line Nivolumab and Relatlimab Plus Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma: The Phase II RELATIVITY-060 Study. J Clin Oncol. 2024 Jun 10;42(17):2080-2093. doi: 10.1200/JCO.23.01636. Epub 2024 May 9.

    PubMed 38723227

  • Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

    PubMed 35623069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986213, Nivolumab and XELOX in people with Gastric Cancer and Cancer of the Stomach, run by Bristol-Myers Squibb at 79 sites in 17 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 4 inclusion and 4 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Germany, Australia, France, Spain and 12 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 9 May 2022). 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?

BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants (time frame: Up to 25 months). The study lists 2 primary outcomes in all. 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 NCT03662659, which also lists 2 linked publications.

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 5 Feb 2025.

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