Solid TumorPhase 1/2NCT02705105

Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing Mogamulizumab + Nivolumab in people with Solid Tumor and Cancer, run by Kyowa Kirin, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (MTD) or the recommended fixed dose of the combinations of mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Cancer, Carcinoma
What is being tested?: Mogamulizumab + Nivolumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 15 sitesUnited States
Study dates: Feb 2016to 10 Oct 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subject is age 18 years or older;
Subject must have histologically or cytologically confirmed solid tumor;
Subject must have locally advanced or metastatic solid tumor;
Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

Show all 18Show fewer

If the subject is a woman of child-bearing potential or man who is sexually active with woman of child-bearing potential, the subject agrees to use adequate contraception from signing of the ICF, for the duration of study participation; and for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of IMP for men;
Subjects who have adequate hematological, renal, hepatic and respiratory functions defined.
The subject is willing to undergo tumor biopsy during the Screening period, or if the tumor is inaccessible for biopsy, archived tumor material must be available for submission;
Subjects who voluntarily signed and dated Institutional Review Board approved informed consent form in accordance with regulatory and institutional guidelines.
Hepatocellular Carcinoma Inclusion Criteria:
Histologically confirmed hepatocellular carcinoma not amenable for management with curative intent by surgery or local therapeutic measure;
Subject must have received sorafenib treatment and either:
have had documented radiographic or symptomatic progression during or after sorafenib therapy; OR
be intolerant of sorafenib (defined as Grade 2 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards AND 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily) AND/OR Grade 3 drug-related adverse event which 1) persisted in spite of comprehensive supportive therapy according to institutional standards OR 2) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level (to 400 mg once daily); OR must have documented refusal of sorafenib;
Subject has Child-Pugh score of ≤6, i.e., Child-Pugh A (Appendix 2);
INR ≤ 2.3 or Prothrombin time (PT) ≤ 6 seconds above control;
Subject has HBV DNA viral load undetectable or < 100 IU/mL at screening. If subject has detectable HBsAg, HBeAg, or HBV DNA (indicating ongoing viral replication of hepatitis B, he/she must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. If not on antiviral therapy at screening, then the subject must initiate treatment per regional standard of care guidelines prior to C1D1 and must be willing to continue antiviral therapy while on study treatment.

Who cannot join

Female subject who is pregnant or breast-feeding, or any subject expecting to conceive or father a child during this study;
Subjects with uncontrolled and significant inter-current illness.
Subjects has psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements;
Subject has primary central nervous system (CNS) tumor or known CNS metastases and/or history of CNS metastases and/or carcinomatous meningitis; Exception: Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. In addition, subjects must be off corticosteroids for 4 weeks prior to enrollment.
Subject has received prior therapy for cancer or major surgery within 28 days, or 42 days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1, or 14 days for tamoxifen;
Subject has received radiotherapy or radiosurgery within 14 days prior to Cycle 1 Day 1;

Show all 28Show fewer

Subject has been previously treated with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
Subject has been previously treated with mogamulizumab;
Subject has a history of allergy or hypersensitivity to study drug components;
Subject has received a live, attenuated vaccine within 28 days prior to Cycle 1 Day 1;
Subject has a history of organ transplant or allogeneic bone marrow transplant;
Subject has any unresolved toxicity Grade > 1 from previous anti-cancer therapy
Subject use of immunosuppressive medication within 14 days before Cycle 1 Day 1.
Subjects who have known active autoimmune disease or a history of autoimmune disease which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids;
Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;
Subjects who have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or Wegener's granulomatosis;
Subject has primary or acquired immunodeficiency or known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
Subject who tests positive for hepatitis B surface antigen (HBVsAg) or hepatitis C RNA indicating acute or chronic infection except for subjects with hepatocellular carcinoma;
Subject has another active malignancy requiring concurrent intervention;
Subject who is receiving any other investigational agents;
Subject has another condition that, in the opinion of the Investigator and/or Sponsor, would interfere with evaluation of the IMP or interpretation of subject safety or study results;
Subject has a history of pneumonitis or interstitial lung disease.
Hepatocellular Carcinoma Exclusion Criterion:
Any history of hepatic encephalopathy
Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires paracentesis for control;
Active coinfection with both hepatitis B (i.e., HBVsAg and/or hepatitis B DNA) and hepatitis C (i.e., hepatitic C RNA)
Hepatitis D infection in subjects with hepatitis B
Any history of clinically meaningful variceal bleeding within the last three months.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Albuquerque, New Mexico, 87106
Study site
Augusta, Georgia, 30912
Study site
Baltimore, Maryland, 21205
Study site
Chicago, Illinois, 60637
Study site
Columbus, Ohio, 43210
Study site
Gilbert, Arizona, 85234
Study site
Goldsboro, North Carolina, 27534
Study site
Greenbrae, California, 94904
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32224
Study site
Kalamazoo, Michigan, 49007
Study site
Los Angeles, California, 90033
Study site
Philadelphia, Pennsylvania, 19111-2497
Study site
Piscataway, New Jersey, 08854
Study site
Portland, Oregon, 97213

Other trials in United States

About this study

Official title: Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination With Nivolumab in Subjects With Locally Advanced or Metastatic Solid Tumors

Read the detailed description

This is a multicenter, Phase 1/2 open-label, dose-finding and cohort expansion study of the anti-CCR4 antibody mogamulizumab in combination therapy with the anti-PD-1 antibody nivolumab in adult subjects with locally advanced or metastatic solid tumors.

Phase 1 will identify the maximum tolerated dose (MTD) or the highest protocol-defined dose in absence of exceeding the MTD, of the combination regimen of mogamulizumab and nivolumab subjects. Phase 1 will enroll up to 12 subjects. Phase 2 will explore the safety, efficacy and anti-tumor activity of the highest tolerated dose of the combination regimen. Phase 2 will enroll up to 184 subjects.

Conditions: Solid Tumor, Cancer, Carcinoma, Hepatocellular Carcinoma, HCC
Being tested: Mogamulizumab + Nivolumab
Keywords: Metastatic Solid Tumors, Advanced Solid Tumors, KW-0761, ONO-4538/BMS-936558, Anti-tumor, Mogamulizumab, Nivolumab, Oncology, HCC, Hepatocellular carcinoma
Medical subject headings: Neoplasms, Carcinoma, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mogamulizumab + NivolumabBiological
Also called Mogamulizumab: KW-0761, Nivolumab: ONO-4538/BMS-936558
i.v. administration

Study groups in NCT02705105
Study group	Role	What they receive
Dose-Finding Cohort	Experimental	Cycle 1 Days 1, 8, 15, and 22: Dose Level 1 of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Dose Level 1 of Mogamulizumab + Nivolumab If >1 patient has a DLT at first dose level, then the following cohort will be enrolled: Cycle 1 Days 1, 8, 15, and 22: Optional Dose Level of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Optional Dose Level of Mogamulizumab + Nivolumab Receives: Biological: Mogamulizumab + Nivolumab
Expansion Cohort	Experimental	Cycle 1 Days 1, 8, 15, and 22: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subjects will be separated further into cohorts by tumor type Receives: Biological: Mogamulizumab + Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD)
The MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)
Measured: From the first dose of study medications until 14 days after the last dose of study medication
Number of Subjects Experiencing Dose-limiting Toxicity
combination of mogamulizumab and nivolumab
Measured: From the first dose of study medications until 14 days after the last dose of study medication

Secondary outcomes (1)

Objective Tumor Response Rate According to RECIST
To evaluate the anti-tumor activity of the combination of mogamulizumab and nivolumab based on the Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1.
Measured: From baseline to every 12 weeks, until data cut off

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201610 Oct 2018

First posted10 Mar 2016 (estimated)
Study startFeb 2016
Primary completion22 Aug 2018
Study completion10 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Solid TumorStudies 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02705105
Sponsor's protocol ID: 0761-014
Status last verified: Apr 2024
First submitted: 24 Feb 2016
Last updated: 25 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

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: Open-label, Multicenter, Phase 1/2 Study of Mogamulizumab in Combination With Nivolumab in Subjects With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT02705105
Acronym / sponsor ID: 0761-014
Conditions: Solid Tumor, Cancer, Carcinoma, Hepatocellular Carcinoma, HCC
Keywords: Metastatic Solid Tumors, Advanced Solid Tumors, KW-0761, ONO-4538/BMS-936558, Anti-tumor, Mogamulizumab, Nivolumab, Oncology
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Feb 2016 (actual)
Primary completion: 22 Aug 2018 (actual)
Study completion: 10 Oct 2018 (actual)
First posted: 10 Mar 2016 (estimated)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dose-Finding Cohort	Experimental	Biological: Mogamulizumab + NivolumabCycle 1 Days 1, 8, 15, and 22: Dose Level 1 of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Dose Level 1 of Mogamulizumab + Nivolumab If >1 patient has a DLT at first dose level, then the following cohort will be enrolled: Cycle 1 Days 1, 8, 15, and 22: Optional Dose Level of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Optional Dose Level of Mogamulizumab + Nivolumab
Expansion Cohort	Experimental	Biological: Mogamulizumab + NivolumabCycle 1 Days 1, 8, 15, and 22: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subsequent Cycles Days 1 and 15: Maximum Tolerated Dose of Mogamulizumab + Nivolumab Subjects will be separated further into cohorts by tumor type

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Subject is age 18 years or older;
Subject must have histologically or cytologically confirmed solid tumor;
Subject must have locally advanced or metastatic solid tumor;
Subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist.
Subjects who have evaluable lesion per guideline of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Key exclusion criteria (28 listed)

Female subject who is pregnant or breast-feeding, or any subject expecting to conceive or father a child during this study;
Subjects with uncontrolled and significant inter-current illness.
Subjects has psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements;
Subject has primary central nervous system (CNS) tumor or known CNS metastases and/or history of CNS metastases and/or carcinomatous meningitis; Exception: Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. In addition, subjects must be off corticosteroids for 4 weeks prior to enrollment.
Subject has received prior therapy for cancer or major surgery within 28 days, or 42 days for nitrosourea or mitomycin C, prior to Cycle 1 Day 1, or 14 days for tamoxifen;

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
Mogamulizumab + NivolumabAlso: Mogamulizumab: KW-0761, Nivolumab: ONO-4538/BMS-936558i.v. administration	Biological	Dose-Finding Cohort, Expansion Cohort

Primary outcome

Maximum Tolerated Dose (MTD)
Time frame: From the first dose of study medications until 14 days after the last dose of study medication
The MTD was defined as one dose level below the dose level of the cohort where ≥ one-third of the subjects experienced a dose-limiting toxicity (DLT)
Number of Subjects Experiencing Dose-limiting Toxicity
Time frame: From the first dose of study medications until 14 days after the last dose of study medication
combination of mogamulizumab and nivolumab

1 secondary outcome

Objective Tumor Response Rate According to RECIST
Time frame: From baseline to every 12 weeks, until data cut off

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1	4	0
Phase 2	110	1

Primary outcome: Maximum Tolerated Dose (MTD)

Time frame: From the first dose of study medications until 14 days after the last dose of study medication. Count of participants. Unit: Participants

Measure	All in Phase 1 Cohort n = 4
Subjects enrolled at Dose Level 1	4
Subjects who successfully tolerated Dose Level 1	4

Primary outcome: Number of Subjects Experiencing Dose-limiting Toxicity

Time frame: From the first dose of study medications until 14 days after the last dose of study medication. Count of participants. Unit: Participants

Measure	All in Phase 1 Cohort n = 4
Subjects enrolled at Dose Level 1	4
Subjects who experienced DLT at Dose Level 1	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the date of informed consent to 100 days after the last dose of IMP.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All in Phase 1 Cohort	2 of 4 (50%)	4 of 4 (100%)	0 of 4
NSCLC, Squamous Cell	2 of 5 (40%)	5 of 5 (100%)	0 of 5
NSCLC, Nonsquamous, PD-L1 Non-Expressing	3 of 4 (75%)	4 of 4 (100%)	0 of 4
Squamous Cell Carcinoma of Head and Neck	6 of 10 (60%)	10 of 10 (100%)	0 of 10
Colorectal Carcinoma, Non-MSI High	18 of 29 (62.1%)	28 of 29 (96.6%)	1 of 29
Ovarian/Fallopian Tube/Primary Peritoneal Carcinoma	11 of 21 (52.4%)	21 of 21 (100%)	0 of 21
Hepatocellular Carcinoma (HCC)	17 of 24 (70.8%)	24 of 24 (100%)	2 of 24
Pancreatic Adenocarcinoma	11 of 17 (64.7%)	17 of 17 (100%)	3 of 17

Limitations and caveats (from the sponsor): A decision was made by the Sponsor and Collaborator (BMS) in March of 2018 to stop enrollment in Phase 2 of study despite not all cohorts having reached the Stage 1 target enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mogamulizumab + Nivolumab in people with Solid Tumor and Cancer, run by Kyowa Kirin, Inc. at 15 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 18 inclusion and 28 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 15 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose (MTD) (time frame: From the first dose of study medications until 14 days after the last dose of study medication). The study lists 2 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 NCT02705105.

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.