Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476123
• Other study ID #: 0761-013
• Status: Completed
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: December 21, 2018

Study information

• Verified date: June 2019
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of Mogamulizumab and Nivolumab in subjects with locally advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 21, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.

• Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.

• Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• Subjects with life expectancy > 12 weeks.

• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

• Potential child-bearing female who has agreed with contraception and not breast-feeding. For male who also has agreed with contraception.

• Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.

• Must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy.

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors.

Exclusion Criteria:

• Female subjects who are pregnant or breast-feeding.

• Subjects with uncontrolled and significant inter-current illness.

• Subjects with known central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Subjects who have been previously treated with an anti-programmed death 1 (PD-1), anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

• Subjects who have been previously treated with Mogamulizumab.

• Subjects with any prior Grade = 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE.

• Subjects with a history of severe hypersensitivity reactions to drugs.

• Subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin C) prior to Cycle 1 Day 1.

• Subjects who have known active autoimmune disease or syndrome.

• Subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious GI chronic conditions associated with diarrhea.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Biological:
• Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)
i.v. administration

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Hakko 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 subjects reporting adverse events		From the first dose of study medications until 90 days after the last dose of study medication
Primary	Number of subjects reporting serious adverse events		From the first dose of study medications until 90 days after the last dose of study medication
Primary	Percentage of subjects reporting serious adverse events		From the first dose of study medications until 90 days after the last dose of study medication
Primary	Percentage of subjects reporting adverse events		From the first dose of study medications until 90 days after the last dose of study medication
Primary	Number of subjects experiencing dose-limiting toxicity		For 28 days from the first dose of study medications