Advanced Solid TumorsPhase 1NCT02301130
Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors
A Phase 1 study testing mogamulizumab, MEDI4736 (Durvalumab) and tremelimumab in people with Advanced Solid Tumors, run by Kyowa Kirin, Inc. at 7 sites in United States.
Trial summary
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- mogamulizumab, MEDI4736 (Durvalumab) and tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Nov 2014to 5 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Georgia Cancer Center
Augusta, Georgia, 30912
MD Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic
Los Angeles, California, 90025
UCLA Hematology & Oncology Clinic
Los Angeles, California, 90095
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Being tested
- mogamulizumab, MEDI4736 (Durvalumab), tremelimumab
- Keywords
- advanced solid tumors, solid tumors, mogamulizumab, MEDI4736 (Durvalumab), Tremelimumab, POTELIGEO®, KW-0761
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mogamulizumabBiological
Also called KW-0761, POTELIGEO®
Mogamulizumab will be administered intravenously (IV).
MEDI4736 (Durvalumab)Biological
Also called Durvalumab
MEDI4736 will be administered intravenously (IV).
tremelimumabBiological
Also called ticilimumab, CP-675,206
Tremelimumab will be administered intravenously (IV).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: mogamulizumab; Biological: tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting adverse events
Measured: Screening through 90 days after the last dose of study medication
Number of subjects reporting serious adverse events
Measured: Screening through 90 days after the last dose of study medication
Percentage of subjects reporting serious adverse events
Measured: Screening through 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
Measured: Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
Measured: First dose of study medications through 4 weeks after the last dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start26 Nov 2014
- Primary completion8 Dec 2017
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301130
- Sponsor's protocol ID
- 0761-012
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2014
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32586937
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02301130
- Acronym / sponsor ID
- 0761-012
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors, solid tumors, mogamulizumab, MEDI4736 (Durvalumab), Tremelimumab, POTELIGEO®, KW-0761
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 26 Nov 2014 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mogamulizumab + MEDI4736 (Durvalumab) | Experimental | Biological: mogamulizumab, Biological: 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. |
| mogamulizumab + tremelimumab | Experimental | Biological: mogamulizumab, Biological: tremelimumabDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mogamulizumabAlso: KW-0761, POTELIGEO®Mogamulizumab will be administered intravenously (IV). | Biological | mogamulizumab + MEDI4736 (Durvalumab), mogamulizumab + tremelimumab |
| MEDI4736 (Durvalumab)Also: DurvalumabMEDI4736 will be administered intravenously (IV). | Biological | mogamulizumab + MEDI4736 (Durvalumab) |
| tremelimumabAlso: ticilimumab, CP-675,206Tremelimumab will be administered intravenously (IV). | Biological | mogamulizumab + tremelimumab |
Primary outcome
Number of subjects reporting adverse events
Time frame: Screening through 90 days after the last dose of study medication
Number of subjects reporting serious adverse events
Time frame: Screening through 90 days after the last dose of study medication
Percentage of subjects reporting serious adverse events
Time frame: Screening through 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
Time frame: Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
Time frame: First dose of study medications through 4 weeks after the last dose of study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 32586937Zamarin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mogamulizumab, MEDI4736 (Durvalumab) and tremelimumab in people with Advanced Solid Tumors, run by Kyowa Kirin, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects reporting adverse events (time frame: Screening through 90 days after the last dose of study medication). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.