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Completed

NCT Number: NCT02999295

A Phase 1/2 Study of Ramucirumab Plus Nivolumab in Participants With Gastric or GEJ Cancer

The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Region (GEJ) Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center Hospital

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced or recurrent unresectable gastric or GEJ cancer
  • Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
  • Patients with normal oral intake
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients who have measurable target lesion
  • Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
  • Patients with adequate organ function
  • Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
  • Patients with written informed consent

Exclusion criteria

  • Patients have double cancer
  • Patients have infection required systemic therapy
  • Known central vervous system (CNS) metastasis
  • Patients with history of pneumonitis or pulmonary fibrosis
  • Patients with history of serious anaphylaxis induced by antibody preparation
  • Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
  • Female who is pregnant, lactating or suspected pregnancy
  • Patients with psychosis or dementia to interfere to obtain informed consent appropriately

Treatment and study plan

Ramucirumab

Biological

Ramucirumab (8 mg/kg) is administered.

Other names: LY3009806

Nivolumab

Biological

Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.

Other names: ONO-4538

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: Phase 1, course 1 (up to 28 days)

    Number of participants with dose limiting toxicities (DLTs)

  2. Progression free survival rate after 6 months

    Time frame: from baseline to 6 months

    Progression free survival rate after 6 months

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: from baseline to date of treatment cessation, approximately 24 months

    Number of participants with adverse events

  2. Objective response rate (ORR)

    Time frame: from baseline to date of disease progression, approximately 24 months

    percentage of participants with with a best response of complete response (CR) or partial response (PR)

  3. Disease control rate (DCR)

    Time frame: from baseline to date of disease progression, approximately 24 months

    percentage of participants with with a best response of CR, PR or stable disease (SD)

  4. Overall survival (OS)

    Time frame: from baseline to date of death, approximately 24 months

    Overall survival (OS)

  5. Progression free survival (PFS)

    Time frame: from baseline to date of disease progression or death, approximately 24 months

    Progression free survival (PFS)

Sponsors and collaborators

Lead sponsor

National Cancer Center, Japan

Other Gov

Collaborators

  • Fiverings Co., Ltd.
  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Dec 21, 2016
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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