Skip to main content
OpenTrials
Completed

NCT Number: NCT02946671

Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1).

To assess the behavior of immune cells in peripheral blood and tumor.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Renal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Osaka University

Suita, Osaka, 5650871, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who enable to have standard operation
  • Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
  • Patients with written informed consent
  • Patients who have measurable target lesion
  • Patients who are enable to undergo biopsy for sampling tumor tissue

Exclusion criteria

  • Known or previous autoimmune disease
  • Known or suspected interstitial lung disease (ILD)
  • Patients with history of serious anaphylaxis induced by antibody preparation
  • Uncontrollable hypertension
  • Uncontrollable endocrine disease
  • Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
  • Uncontrollable diabetes
  • Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease
  • Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
  • Known or suspected infection or inflammatory disease
  • Prior therapy with hematopoietic stem cell transplantation
  • Known or suspected central nervous system (CNS) involvement

Treatment and study plan

mogamulizumab

Biological

Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.

Other names: KW-0761

Nivolumab

Biological

Nivolumab (3.0 mg/kg) is administered.

Other names: ONO-4538

Primary outcomes

  1. Number of patients with adverse events including intraoperative and postoperative complications

    Time frame: from first administration to 60 days after the final administration or to 30 days after the standard operation

    Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.

  2. Rate of Foxp3-positive patients in tumor by immunohistochemical analysis

    Time frame: from baseline until standard operation, an average of 7 weeks

Secondary outcomes

  1. Objective tumor response rate according to RECIST v1.1

    Time frame: from baseline to 6 weeks after the first administration

  2. Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)

    Time frame: from baseline to 60 days after the final administration or to 30 days after the standard operation

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Collaborators

  • Clinical Study Support, Inc.
  • Fiverings Co., Ltd.
  • Kyowa Kirin Co., Ltd.
  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Mar 6, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.