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AzTrials

Recurrent/Metastatic Gastric CancerPhase 1/2NCT05535569

Phase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer

A Phase 1/2 study testing Nivolumab, Paclitaxel in people with Recurrent/Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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

This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Recurrent/Metastatic Gastric Cancer
What is being tested?
Nivolumab, Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSouth Korea
Study dates
17 Jul 2017to 22 Nov 2021
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has provided digned written informed Consent
  • Is male or female ≥19 years of age
  • Has a histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
  • Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue
  • Has a life expectancy of at least 3 months
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Has measurable or evaluable disease as determined by RECIST 1.1.
  • Is able to swallow and retain orally administered medication
  • Has an adequate baseline organ function defined as:
  • White blood cells ≥3000/mm3 and neutrophils ≥1500/mm3
  • Platelets ≥100000/mm3
  • Hemoglobin ≥9.0 g/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN) of the study site (or ≤5.0 × ULN in patients with liver metastases)
  • Total bilirubin ≤2.0 × ULN
  • Creatinine≤1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60ml/min.

Who cannot join

  • Has HER2-positive or indeterminate gastric cancer
  • Have multiple cancers
  • Have a current or past history of severe hypersensitivity to any other antibody products
  • Have concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
  • Have a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging (preferably CT) or clinical findings
  • Have brain or meninx metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment.
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  • Have pericardial fluid, pleural effusion, or ascites requiring treatment
  • Have a history of uncontrollable or significant cardiovascular disease
  • Have systemic infection requiring treatment
  • Are contraindicated for paclitaxel
  • Has had prior treatment with:
  • Require or, within 28 days before treatment, have received systemic corticosteroids or immunosuppressants
  • Have undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment
  • Have received radiotherapy for gastric cancer within 28 days before treatment or radiotherapy for bone metastases within 14 days before treatment
  • Have a positive test result for human immunodeficiency virus-1 (HIV-1) antibody,
  • Hepatitis B surface protein (HBs) antigen and HBV titer >2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result
  • Are pregnant or breastfeeding, or possibly pregnant
  • Has any unresolved ≥Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or anemia
  • Have previously received nivolumab, anti-programmed cell death-1 (PD-1) antibody, anti-PD-L1 antibody, anti-programmed cell death-ligand 2 (PD-L2) antibody, anti-CD137 antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody, or other therapeutic antibodies or pharmacotherapies for the regulation of T-cells
  • Are incapable of providing consent for specific reasons, such as concurrent dementia
  • Are otherwise inappropriate for this study in the investigator's or subinvestigator's opinion.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Severance Hospital

    Seoul

Other trials in South Korea

About this study

This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment.

Read the detailed description

This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment.

Patients who are EBV-related, MSI-high, or PD-L1 positive will be confirmed by immunohistochemistry (IHC) in a central laboratory (Yonsei Cancer Center), and who meet all eligibility criteria will be enrolled to this study and receive treatment with nivolumab and paclitaxel until progressive disease is confirmed or at least 1 discontinuation criterion is met. It was assumed that about 15% of screened patients will be categorized EBV-related, MSI-high, or PD-L1 positive gastric cancer based on previously reported study results. Part 1>> Phase Ib Phase Ib: 6-12 (The actual number of subjects will be determined by the number of dose escalations to identify MTD and RP2D) Part 2>> Phase II - At the RP2D dose level in phase I part, we will expand phase 2 study for a total of 50 patients. Patients will be treated until the time of disease progression, intolerable toxicities, patient's refusal or consent withdrawal. Tumor assessment will be done every 6 weeks.

Being tested
Nivolumab, Paclitaxel
Keywords
Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer, Nivolumab
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Nivolumab, PaclitaxelDrug

    Increasing dose levels of paclitaxel (70 mg/m2 or 80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle) in combination with a fixed dose of nivolumab (3 mg/kg on Days 1 and 15 of a 28-day treatment cycle) will be explored using a 3+3 design to evaluate the safety and tolerability and to determine a MTD.

Study groups in NCT05535569
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Drug: Nivolumab, Paclitaxel

What is being measured

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

  1. (Phase Ib) Maximum Tolerated dose (MTD)

    Maximum Tolerated dose (MTD) as determined by Dose limiting Toxicity (DLT).

    Measured: 424 weeks

  2. (Phase Ib) Recommended phase 2 dose

    Recommended phase 2 dose as determined by Dose limiting Toxicity (DLT).

    Measured: 424 weeks

  3. (Phase II) PFS

    Progression-free survival (PFS): Defined as the time from start of study treatment until the date of objective disease progression or death (by any cause in the absence of disease progression) Progression is defined in accordance with the RECIST v1.1 criteria. PFS is defined as the interval between the date of first dose and the earliest date of disease progression or death due to any cause.

    Measured: 424 weeks

Secondary outcomes (4)

  1. OS

    Overall Survival (OS): the time from the date of first dose and the date of death from any cause

    Measured: 24 weeks

  2. ORR

    Overall response rate (ORR): defined as the percentage of subjects with a confirmed CR or PR per RECIST v1.1 relative to the total number of subjects

    Measured: 24 weeks

  3. DCR

    Disease Control Rate (DCR): the proportion of randomized patients achieving a best overall response of CR, PR, or SD.

    Measured: 24 weeks

  4. PFS

    Progression-free survival (PFS): To evaluate the treatment effect of nivolumab and paclitaxel on progression-free survival (PFS) rate at 24 weeks

    Measured: 24 weeks

Timeline

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

  1. First posted10 Sep 2022
  2. Study start17 Jul 2017
  3. Primary completion22 Nov 2021
  4. Study completion22 Nov 2021

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05535569
Sponsor's protocol ID
4-2017-0277
Status last verified
Sep 2022
First submitted
7 Sep 2022
Last updated
10 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Paclitaxel in people with Recurrent/Metastatic Gastric Cancer, run by Yonsei University at 1 site in South Korea.

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 15 inclusion and 21 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 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

(Phase Ib) Maximum Tolerated dose (MTD) (time frame: 424 weeks). The study lists 3 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 NCT05535569.

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 10 Sep 2022.

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