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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946671
• Other study ID #: KW0761-IIT-02
• Status: Completed
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Kidney Neoplasms
• Lung Cancer
• Mouth Neoplasms
• Oral Cancer
• Renal Cancer

Intervention

Biological:
• Mogamulizumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
• Nivolumab
Nivolumab (3.0 mg/kg) is administered.

Locations

Country	Name	City	State
Japan	Osaka University	Suita	Osaka

Sponsors (5)

Lead Sponsor	Collaborator
Osaka University	Clinical Study Support, Inc., Fiverings Co., Ltd., Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse events including intraoperative and postoperative complications	Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.	from first administration to 60 days after the final administration or to 30 days after the standard operation
Primary	Rate of Foxp3-positive patients in tumor by immunohistochemical analysis		from baseline until standard operation, an average of 7 weeks
Secondary	Objective tumor response rate according to RECIST v1.1		from baseline to 6 weeks after the first administration
Secondary	Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)		from baseline to 60 days after the final administration or to 30 days after the standard operation