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

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ClinicalTrials.gov Identifier: NCT02301130
Recruitment Status : Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

Brief Summary:
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: mogamulizumab Biological: MEDI4736 (Durvalumab) Biological: tremelimumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Study Start Date : November 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: mogamulizumab + MEDI4736 (Durvalumab)

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

Part 1 (Dose Escalation Phase)

- During Cohort 1A to 4A, increased doses of mogamulizumab and MEDI4736 (Durvalumab) 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 (Durvalumab)
MEDI4736 will be administered intravenously (IV).
Other Name: Durvalumab
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 4B, 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



Primary Outcome Measures :
  1. Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
  2. Number of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
  3. Percentage of subjects reporting serious adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
  4. Percentage of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
  5. Number of subjects experiencing dose-limiting toxicity [ Time Frame: First dose of study medications through 4 weeks after the last dose of study medication ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 with the exception of PD-1 or PD-L1 blockade therapy for subjects who will be enrolled in treatment arm A. 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;
  • The subject has a tumor suitable for biopsy and is willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1/Visit Day 1;

Exclusion Criteria:

  • Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior prior or within 6 weeks prior to Cycle 1/Visit Day 1 for nitrosoureas or mitomycin C;
  • Concurrent or prior use of immunosuppressive medication within 28 days;
  • Active or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.;
  • Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301130


Locations
United States, California
The Angeles Clinic
Los Angeles, California, United States, 90025
UCLA Hematology & Oncology Clinic
Los Angeles, California, United States, 90095
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Kyowa Kirin Pharmaceutical Development, Inc.
AstraZeneca

Responsible Party: Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier: NCT02301130     History of Changes
Other Study ID Numbers: 0761-012
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: August 2017

Keywords provided by Kyowa Kirin Pharmaceutical Development, Inc.:
advanced solid tumors
solid tumors
mogamulizumab
MEDI4736 (Durvalumab)
Tremelimumab
POTELIGEO®
KW-0761

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