Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-16147

Full Title

Open-label, Multicenter Phase 1/2 Study of Mogamulizumab in Combination with Nivolumab in Subjects with Locally Advanced or Metastatic Solid Tumors

Purpose

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.

Study Objective

This is a multicenter, Phase 1/2 open-label, dose-finding and cohort expansion study of the

anti-CCR4 antibody mogamulizumab in combination therapy with the anti-PD-1 antibody

nivolumab in adult subjects with locally advanced or metastatic solid tumors.

Phase 1 will identify the maximum tolerated dose (MTD) or the highest protocol-defined dose

in absence of exceeding the MTD, of the combination regimen of mogamulizumab and nivolumab

subjects. Phase 1 will enroll up to 12 subjects. Phase 2 will explore the safety, efficacy

and anti-tumor activity of the highest tolerated dose of the combination regimen. Phase 2

will enroll up to 175 subjects.

Are you eligible?

Inclusion Criteria:

Subject is age 18 years or older;

Subject must have histologically or cytologically confirmed solid tumor;

Subject must have locally advanced or metastatic solid tumor;

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.

Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0

or 1;

If the subject is a woman of child-bearing potential or man who is sexually active

with woman of child-bearing potential, the subject agrees to use adequate

contraception from signing of the ICF, for the duration of study participation; and

for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of

IMP for men;

Subjects who have adequate hematological, renal, hepatic and respiratory functions

defined.

The subject is willing to undergo tumor biopsy during the Screening period, or if the

tumor is inaccessible for biopsy, archived tumor material must be available for

submission;

Subjects who voluntarily signed and dated Institutional Review Board approved

informed consent form in accordance with regulatory and institutional guidelines.

Exclusion Criteria:

Female subject who is pregnant or breast-feeding, or any subject expecting to

conceive or father a child during this study;

Subjects with uncontrolled and significant inter-current illness.

Subjects has psychiatric illness/social situations that in the opinion of the

investigator would limit compliance with study requirements;

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

meningitis.

Subject has received prior therapy for cancer or major surgery within 28 days, or 42

days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1;

Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day

1;

Subject has been previously treated with an anti-PD-1, anti-PD-L1, anti-PD-L2,

anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically

targeting T-cell co-stimulation or checkpoint pathways;

Subject has been previously treated with mogamulizumab;

Subject has a history of allergy or hypersensitivity to study drug components;

Subject has received a live, attenuated vaccine within 28 days prior to Cycle 1 Day

1;

Subject has a history of organ transplant or allogeneic bone marrow transplant;

Subject has any unresolved toxicity Grade > 1 from previous anti-cancer therapy

Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.

Subjects who have known active autoimmune disease or a history of autoimmune disease

which may affect vital organ function or require immune suppressive treatment

including systemic corticosteroids;

Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;

Subjects who have a history of inflammatory bowel disease, Crohn's disease,

ulcerative colitis, celiac disease, or Wegener's granulomatosis;

Subject has primary or acquired immunodeficiency or known history of testing positive

for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;

Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C

RNA indicating acute or chronic infection;

Subject has another active malignancy requiring concurrent intervention;

Subject who is receiving any other investigational agents;

Subject has another condition that, in the opinion of the Investigator and/or

Sponsor, would interfere with evaluation of the IMP or interpretation of subject

safety or study results;

Subject has a history of pneumonitis or interstitial lung disease.

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