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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-12-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02946671

Gastric Cancer Esophageal Cancer Lung Cancer +2 more

COMPLETED PHASE1

Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

NCT02705105

Solid Tumor Cancer Carcinoma +2 more

COMPLETED PHASE1/PHASE2

Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors

NCT02281409

Advanced Solid Tumors Metastatic Solid Tumors

COMPLETED PHASE1/PHASE2

A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

NCT05773937

Advanced Malignant Solid Tumors

RECRUITING PHASE1

A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread

NCT03158272

Advanced Malignancies

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mogamulizumab+Nivolumab

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

i.v. administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

i.v. administration

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No