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

Osaka University

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Gastric Cancer; Renal Cancer; Lung Cancer; Oral Cancer

Treatments: Biological: Mogamulizumab; Biological: Nivolumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02946671

KW0761-IIT-02

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Mogamulizumab

Cohort 2

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Mogamulizumab

Cohort 3

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Mogamulizumab