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OpenTrials
Completed

NCT Number: NCT02301130

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinic, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mogamulizumab

Biological

Mogamulizumab will be administered intravenously (IV).

Other names: KW-0761, POTELIGEO®

MEDI4736 (Durvalumab)

Biological

MEDI4736 will be administered intravenously (IV).

Other names: Durvalumab

Tremelimumab

Biological

Tremelimumab will be administered intravenously (IV).

Other names: ticilimumab, CP-675,206

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 25, 2014
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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