Trial | NCT02946671  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
Study Started
Mar 31
2016
Primary Completion
Mar 31
2020
Study Completion
Mar 31
2020
Last Update
Mar 06
2020

Biological Mogamulizumab

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

  • Other names: KW-0761

Biological Nivolumab

Nivolumab (3.0 mg/kg) is administered.

  • Other names: ONO-4538

Cohort 1 Experimental

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

Cohort 2 Experimental

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

Cohort 3 Experimental

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

Criteria 

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
No Results Posted