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AzTrials

Gastric CancerPhase 2NCT03704077

An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Relatlimab + Nivolumab, Nivolumab and Paclitaxel in people with Gastric Cancer and Cancer of the Stomach, run by Bristol-Myers Squibb at 84 sites in 14 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Relatlimab + Nivolumab, Nivolumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
84 sitesin 14 countries
Study dates
31 Oct 2019to 30 Sep 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
  • Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
  • Available tumor tissue for biomarker analysis

Who cannot join

  • Must not have squamous cell or undifferentiated GC or GEJ
  • Untreated known central nervous system (CNS) metastases
  • Uncontrolled or significant cardiovascular disease
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

84 sites in 14 countries.

84 sites in 14 countries

United States20 sites

  • Local Institution

    Allentown, Pennsylvania, 18103

  • Local Institution

    Aurora, Colorado, 80045

  • Local Institution

    Bakersfield, California, 93309

  • Local Institution

    Boston, Massachusetts, 02215

  • Local Institution

    Chapel Hill, North Carolina, 27599

  • Local Institution

    Charlotte, North Carolina, 28204

  • Local Institution

    Daphne, Alabama, 36526

  • Local Institution

    Fargo, North Dakota, 58102

  • Local Institution

    Fullerton, California, 92835

  • Local Institution

    Lakewood, Colorado, 80228

  • Local Institution

    Los Angeles, California, 90095

  • Local Institution

    Marietta, Georgia, 30060

  • Local Institution

    Miami, Florida, 33176

  • Local Institution

    New Brunswick, New Jersey, 08009

  • Local Institution

    Redondo Beach, California, 90277

  • Local Institution

    Santa Barbara, California, 93105

  • Local Institution

    Sioux Falls, South Dakota, 57104

  • Local Institution

    St Louis, Missouri, 63110

  • Local Institution

    Tampa, Florida, 33612

  • Local Institution

    Vancouver, Washington, 98684

Other trials in United States

Germany15 sites

  • Local Institution

    Berlin, 13125

  • Local Institution

    Cologne, 50937

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45147

  • Local Institution

    Frankfurt am Main, 60488

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution

    Hamburg, 22763

  • Local Institution

    Hanover, 30625

  • Local Institution

    Jena, 07747

  • Local Institution

    Mainz, 55131

  • Local Institution

    Mannheim, 68167

  • Local Institution

    Marburg, 35043

  • Local Institution

    Paderborn, 33098

  • Local Institution

    Reutlingen, 72764

  • Local Institution

    Wiesbaden, 65199

Other trials in Germany

Brazil7 sites

  • Local Institution

    Barretos, São Paulo, 14780-070

  • Local Institution

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution

    Fortaleza, Ceará, 60430-230

  • Local Institution

    Jaú, São Paulo, 17210-080

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution

    Rio de Janeiro, 22793-080

  • Local Institution

    São Paulo, 01246-000

Other trials in Brazil

Canada7 sites

  • Local Institution

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution

    Hamilton, Ontario, L8V 5C2

  • Local Institution

    Montreal, Quebec, H4J 1C5

  • Local Institution

    Ottawa, Ontario, K1H 8L6

  • Local Institution

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution

    Toronto, Ontario, M5B 1W8

  • Local Institution

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Australia6 sites

  • Local Institution

    Bedford Park, 5024

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Malvern, Victoria, 3144

  • Local Institution

    Melbourne, Victoria, 3000

  • Local Institution

    Murdoch, 6150

  • Local Institution

    Westmead, New South Wales, 2145

Other trials in Australia

Argentina5 sites

  • Local Institution

    Buenos Aires, 1093

  • Local Institution

    Buenos Aires, 1426

  • Local Institution

    CABA, 1199

  • Local Institution

    Córdoba, 5000

  • Local Institution

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Mexico5 sites

  • Local Institution

    Aguascalientes, 20230

  • Local Institution

    Mérida, Yucatán, 97134

  • Local Institution

    Mexico City, Mexico City, 14080

  • Local Institution

    Tuxtla Gutiérrez, Chiapas, 29029

  • Local Institution

    ZONA Centro. LEON, Guanajuato, 37000

Other trials in Mexico

Spain5 sites

  • Local Institution

    Badajoz, 06006

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28034

  • Local Institution

    Madrid, 28050

  • Local Institution

    Valencia, 46026

Other trials in Spain

Italy4 sites

  • Local Institution

    Bergamo, 24127

  • Local Institution

    Milan, 20133

  • Local Institution

    Naples, 80131

  • Local Institution

    Reggio Emilia, 42100

Other trials in Italy

Romania4 sites

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Cluj-Napoca, 400015

  • Local Institution

    Craiova, 200347

  • Local Institution

    Floreşti, 407280

Other trials in Romania

Chile2 sites

  • Local Institution

    Santiago, Santiago Metropolitan, 8330024

  • Local Institution

    Santiago, Santiago Metropolitan

Other trials in Chile

Portugal2 sites

  • Local Institution

    Lisbon, 1649-035

  • Local Institution

    Porto, 4200-072

Other trials in Portugal

Colombia1 site

  • Local Institution

    Medellín

Other trials in Colombia

Puerto Rico1 site

  • Local Institution

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.

Being tested
Relatlimab + Nivolumab, Nivolumab, Paclitaxel, Ramucirumab
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Relatlimab + NivolumabBiological

    Also called BMS-986213

    Specified dose on specified days

  • NivolumabBiological

    Also called Opdivo

    Specified dose on specified days

  • PaclitaxelDrug

    Also called Taxol, Onxal

    Specified dose on specified days

  • RamucirumabDrug

    Also called Cyramza

    Specified dose on specified days

Study groups in NCT03704077
Study groupRoleWhat they receive
Cohort A: relatlimab + nivolumab + paclitaxelExperimentalNot described
Receives: Biological: Relatlimab + Nivolumab; Biological: Nivolumab; Drug: Paclitaxel
Cohort A: nivolumab + paclitaxelExperimentalNot described
Receives: Biological: Nivolumab; Drug: Paclitaxel
Cohort A: ramucirumab + paclitaxelActive comparatorStandard-of-care
Receives: Drug: Paclitaxel; Drug: Ramucirumab
Cohort B: relatlimab + nivolumabExperimentalNot described
Receives: Biological: Relatlimab + Nivolumab; Biological: Nivolumab
Cohort B: nivolumabActive comparatorStandard-of-care
Receives: Biological: Nivolumab
Cohort C: relatlimab + nivolumabExperimentalNot described
Receives: Biological: Relatlimab + Nivolumab; Biological: Nivolumab

What is being measured

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

  1. Overall response rate (ORR)

    Measured: Approximately 31 months

Secondary outcomes (9)

  1. Incidence of adverse events (AEs)

    Measured: Approximately 5 years

  2. Incidence of serious adverse events (SAEs)

    Measured: Approximately 5 years

  3. Incidence of AEs leading to discontinuation

    Measured: Approximately 5 years

  4. Incidence of deaths

    Measured: Approximately 5 years

  5. Incidence of laboratory abnormalities

    Measured: Approximately 5 years

  6. ORR

    Cohort A1

    Measured: Approximately 5 years

  7. Duration of response (DOR)

    Measured: Approximately 5 years

  8. Progression free survival (PFS)

    Measured: Approximately 5 years

  9. Overall survival (OS)

    Measured: Approximately 5 years

Timeline

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

  1. First posted12 Oct 2018
  2. Study start31 Oct 2019 (estimated)
  3. Primary completion27 Feb 2022 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Why it stopped: Replaced it with another clinical trial

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03704077
Sponsor's protocol ID
CA224-061
Other IDs
2018-001070-20, 2018
Status last verified
May 2020
First submitted
9 Oct 2018
Last updated
19 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Relatlimab + Nivolumab, Nivolumab and Paclitaxel in people with Gastric Cancer and Cancer of the Stomach, run by Bristol-Myers Squibb at 84 sites in 14 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 3 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: withdrawn, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Germany, Brazil, Canada, Australia and 9 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Overall response rate (ORR) (time frame: Approximately 31 months). 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 NCT03704077.

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 19 May 2020.

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