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

NCT02476123 | Completed Phase 1 DMC

• 1 other identifier: 0761-013
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (5)

• Number of subjects reporting adverse events

  From the first dose of study medications until 90 days after the last dose of study medication

• Number of subjects reporting serious adverse events

  From the first dose of study medications until 90 days after the last dose of study medication

• Percentage of subjects reporting serious adverse events

  From the first dose of study medications until 90 days after the last dose of study medication

• Percentage of subjects reporting adverse events

  From the first dose of study medications until 90 days after the last dose of study medication

• Number of subjects experiencing dose-limiting toxicity

  For 28 days from the first dose of study medications

Study Arms (1)

Mogamulizumab+Nivolumab

EXPERIMENTAL

During parts 1 and 2, Mogamulizumab and Nivolumab are administered at appropriate intervals. Part 1 (Dose Escalation Part) During Cohort 1 to 2, Mogamulizumab and Nivolumab are administered in combination. Part 2 (Expansion Part) Patients will be treated with maximum tolerated dose established in the dose escalation part for each combination.

Biological: Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)

Interventions

Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558) BIOLOGICAL

i.v. administration

Mogamulizumab+Nivolumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (2)

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• Doi T, Muro K, Ishii H, Kato T, Tsushima T, Takenoyama M, Oizumi S, Gemmoto K, Suna H, Enokitani K, Kawakami T, Nishikawa H, Yamamoto N. A Phase I Study of the Anti-CC Chemokine Receptor 4 Antibody, Mogamulizumab, in Combination with Nivolumab in Patients with Advanced or Metastatic Solid Tumors. Clin Cancer Res. 2019 Nov 15;25(22):6614-6622. doi: 10.1158/1078-0432.CCR-19-1090. Epub 2019 Aug 27.

  PMID: 31455681 DERIVED

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2015
• Primary Completion: February 7, 2018
• Study Completion: December 21, 2018
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

JP (2)