Clinical trial NCT02476123: Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
Official title: Phase 1 Study of Combination Therapy With Mogamulizumab (KW-0761) and Nivolumab (ONO-4538/BMS-936558) in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-06-19
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects reporting adverse events
timeFrame: From the first dose of study medications until 90 days after the last dose of study medication
measure: Number of subjects reporting serious adverse events
timeFrame: From the first dose of study medications until 90 days after the last dose of study medication
measure: Percentage of subjects reporting serious adverse events
timeFrame: From the first dose of study medications until 90 days after the last dose of study medication
measure: Percentage of subjects reporting adverse events
timeFrame: From the first dose of study medications until 90 days after the last dose of study medication
measure: Number of subjects experiencing dose-limiting toxicity
timeFrame: For 28 days from the first dose of study medications
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
citation: 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.