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

NCT02301130 | Completed Phase 1 DMC

• 1 other identifier: 0761-012
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Advanced Solid Tumors

Keywords

advanced solid tumors; solid tumors; mogamulizumab; MEDI4736 (Durvalumab); Tremelimumab; POTELIGEO®; KW-0761

Outcome Measures

Primary Outcomes (5)

• Number of subjects reporting adverse events

  Screening through 90 days after the last dose of study medication

• Number of subjects reporting serious adverse events

  Screening through 90 days after the last dose of study medication

• Percentage of subjects reporting serious adverse events

  Screening through 90 days after the last dose of study medication

• Percentage of subjects reporting adverse events

  Screening through 90 days after the last dose of study medication

• Number of subjects experiencing dose-limiting toxicity

  First dose of study medications through 4 weeks after the last dose of study medication

Study Arms (2)

mogamulizumab + MEDI4736 (Durvalumab)

EXPERIMENTAL

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; Biological: MEDI4736 (Durvalumab)

mogamulizumab + tremelimumab

EXPERIMENTAL

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; Biological: tremelimumab

Interventions

mogamulizumab BIOLOGICAL

Mogamulizumab will be administered intravenously (IV).

Also known as: KW-0761, POTELIGEO®

mogamulizumab + MEDI4736 (Durvalumab); mogamulizumab + tremelimumab

MEDI4736 (Durvalumab) BIOLOGICAL

MEDI4736 will be administered intravenously (IV).

Also known as: Durvalumab

mogamulizumab + MEDI4736 (Durvalumab)

tremelimumab BIOLOGICAL

Tremelimumab will be administered intravenously (IV).

Also known as: ticilimumab, CP-675,206

mogamulizumab + tremelimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin, Inc.: lead
• AstraZeneca: collaborator

Study Sites (7)

The Angeles Clinic

Los Angeles, California, 90025, United States

Location

UCLA Hematology & Oncology Clinic

Los Angeles, California, 90095, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Zamarin D, Hamid O, Nayak-Kapoor A, Sahebjam S, Sznol M, Collaku A, Fox FE, Marshall MA, Hong DS. Mogamulizumab in Combination with Durvalumab or Tremelimumab in Patients with Advanced Solid Tumors: A Phase I Study. Clin Cancer Res. 2020 Sep 1;26(17):4531-4541. doi: 10.1158/1078-0432.CCR-20-0328. Epub 2020 Jun 25.

  PMID: 32586937 DERIVED

MeSH Terms

Interventions

mogamulizumab; durvalumab; tremelimumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: November 26, 2014
• Primary Completion: December 8, 2017
• Study Completion: March 5, 2018
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (7)