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Trial record 3 of 12 for:    kw-0761

Study of Mogamulizumab + MEDI4736 and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Kyowa Hakko Kirin Pharma, Inc.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02301130
First received: November 21, 2014
Last updated: NA
Last verified: November 2014
History: No changes posted
  Purpose

Mogamulizumab in Combination with MEDI4736 and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors


Condition Intervention Phase
Advanced Solid Tumors
Biological: mogamulizumab
Biological: MEDI4736
Biological: tremelimumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Percentage of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing dose-limiting toxicity [ Time Frame: First dose of study medications through 4 weeks after the last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: November 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mogamulizumab + MEDI4736

During Parts 1 and 2, mogamulizumab and MEDI4736 are administered at appropriate intervals.

Part 1 (Dose Escalation Phase)

- During Cohort 1A to 3A, increased doses of mogamulizumab and MEDI4736 are administered.

Part 2 (Cohort Expansion Phase)

  • Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.
Biological: mogamulizumab
Mogamulizumab will be administered intravenously (IV).
Other Names:
  • KW-0761
  • POTELIGEO®
Biological: MEDI4736
MEDI4736 will be administered intravenously (IV).
Experimental: mogamulizumab + tremelimumab

During Parts 1 and 2, mogamulizumab and tremelimumab are administered at appropriate intervals.

Part 1 (Dose Escalation Phase)

- During Cohort 1B to 3B, increased doses of mogamulizumab and tremelimumab are administered.

Part 2 (Cohort Expansion Phase)

  • Patients will be treated with maximum tolerated dose established in the Dose Escalation Phase for each combination.
Biological: mogamulizumab
Mogamulizumab will be administered intravenously (IV).
Other Names:
  • KW-0761
  • POTELIGEO®
Biological: tremelimumab
Tremelimumab will be administered intravenously (IV).
Other Names:
  • ticilimumab
  • CP-675,206

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years;
  • Locally advanced or metastatic solid tumors;
  • Histologically or cytologically confirmed disease;
  • Failed or were intolerant to at least one prior systemic treatment regimen with oral or IV medications and have no additional therapy options known to prolong survival. Subjects with non-small cell lung cancer must have received at least one platinum doublet regimen. Subjects with known epidermal growth factor receptor tyrosine kinase inhibitor activating mutations or anaplastic lymphoma kinase rearrangement must have also exhausted approved targeted therapy options;

Exclusion Criteria:

  • Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior;
  • Concurrent or prior use of immunosuppressive medication within 28 days;
  • Active or prior documented autoimmune or inflammatory bowel disease within 3 years with some exceptions;
  • Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02301130

Contacts
Contact: Kyowa Hakko Kirin Pharma 1-609-919-1100 clinical.info@kyowa-kirin-pharma.com

Locations
United States, California
The Angeles Clinic Not yet recruiting
Los Angeles, California, United States, 90025
United States, Connecticut
Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06520-8028
United States, Florida
H. Lee Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
United States, New York
Memorial Sloan-Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
AstraZeneca
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02301130     History of Changes
Other Study ID Numbers: 0761-012
Study First Received: November 21, 2014
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
advanced solid tumors
solid tumors
mogamulizumab
non-small cell lung
pancreatic
head and neck

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Tremelimumab
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014