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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer Esophageal Cancer Lung Cancer Renal Cancer Oral Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Group Type EXPERIMENTAL

Mogamulizumab

Intervention Type BIOLOGICAL

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

Nivolumab

Intervention Type BIOLOGICAL

Nivolumab (3.0 mg/kg) is administered.

Cohort 2

KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Group Type EXPERIMENTAL

Mogamulizumab

Intervention Type BIOLOGICAL

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

Nivolumab

Intervention Type BIOLOGICAL

Nivolumab (3.0 mg/kg) is administered.

Cohort 3

KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times

Group Type EXPERIMENTAL

Mogamulizumab

Intervention Type BIOLOGICAL

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

Nivolumab

Intervention Type BIOLOGICAL

Nivolumab (3.0 mg/kg) is administered.

Interventions

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Mogamulizumab

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

Intervention Type BIOLOGICAL

Nivolumab

Nivolumab (3.0 mg/kg) is administered.

Intervention Type BIOLOGICAL

Other Intervention Names

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KW-0761 ONO-4538

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No