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Unresectable, Recurrent or Metastatic MelanomaPhase 1NCT04653038

A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma

A Phase 1 study testing MGD013 in people with Unresectable, Recurrent or Metastatic Melanoma and Untreated Mucosal or Acral Lentiginous Melanoma, run by Zai Lab (Shanghai) Co., Ltd. at 13 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MGD013
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
13 sitesChina
Study dates
29 Oct 2020to 2 Mar 2022
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

  • Voluntary and able to provide signed informed consent form
  • Male or female aged ≥ 18 years
  • Patient can comply with protocol requirements as assessed by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, or 1
  • Histologically confirmed unresectable recurrent or metastatic melanoma:
  • Cohort 1: The pathological type is cutaneous or acral lentiginous, or unknown origin. Progressive or recurrent disease on at least one prior line of systemic therapies. In addition, prior systemic therapies must include one line of anti-PD-(L)1 and/or anti-CTLA-4 immune checkpoint inhibitors. Patients with BRAF-mutated or KIT-mutated/amplified melanoma, and prior treatment with vemurafenib or imatinib is not mandatory;
  • Cohort 2: Histologically confirmed pathological type is acral lentiginous or mucosal. No prior systemic therapy for recurrent or metastatic disease.
  • Patients with at least one measurable lesion according to irRECIST; assessed by investigator per irRECIST criteria to establish a baseline tumor assessment, and should be performed within 28 days prior to the first dose.

Who cannot join

  • The pathological type of patient is:
  • Cohort 1: Mucosal melanoma; uveal melanoma;
  • Cohort 2: Cutaneous melanoma; uveal melanoma; melanoma of unknown origin; known BRAF mutation or KIT mutation/amplification.
  • Central nervous system metastases with clinical symptoms. Patients with prior central nervous system metastases who have received local therapy, have stable disease for ≥ 4 weeks, and meet the following criteria can be enrolled:
  • No treatment for central nervous system metastases during the screening period (e.g., surgery, radiotherapy, mannitol, corticosteroid therapy-prednisolone > 10 mg per day or equivalent dose)
  • No progression of central nervous system lesions on MRI or CT within 14 days prior to start of study treatment
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  • No meningeal metastasis or notochord compression
  • Subjects with a history of symptomatic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function or may interfere with the detection and treatment of suspected drug-related pulmonary adverse reactions;
  • Prior treatment with any antibody/drug targeting the regulation of T cell function (immune checkpoint) (e.g., anti-LAG-3, anti-0X-40, anti-CD137, anti-TIM-3, anti-TIGIT, IDO)
  • Patients who have previously received immune checkpoint inhibitors (e.g., anti-PD-(L)1, anti-CTLA-4 antibody) are not included if they experience any of the following immune checkpoint-related adverse events, regardless of recovery:
  • ≥ Grade 3 ocular adverse events
  • Grade 4 liver function abnormalities
  • Grade ≥ 3 neurologic adverse reactions
  • ≥ Grade 3 colitis
  • ≥ Grade 3 renal adverse reactions
  • ≥ Grade 3 pneumonitis

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The first hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • Sir Run Shaw Hospital, School Of Medicine ,Zhejiang University

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

  • Tangdu Hospital

    Xi’an, Shanxi

Other trials in China

About this study

Official title: An Open-label, Multi-cohort, Multi-center Phase I Study Evaluating the Efficacy and Safety of MGD013 in Patients With Unresectable, Recurrent or Metastatic Malignant Melanoma

This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.

Read the detailed description

The study is conducted in two parts for both Cohort 1 and Cohort 2. Part I: Safety evaluation and efficacy exploration for MGD013. Part II: Efficacy expansion based on results from Part I to further evaluate the efficacy effect of MGD013.

Being tested
MGD013
Keywords
Melanoma, MGD013
Medical subject headings
Recurrence, Melanoma

What participants receive

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

  • MGD013Drug

    A fixed dose of MGD013 600mg IV Q2W will be administered to subjects

Study groups in NCT04653038
Study groupRoleWhat they receive
Unresectable, recurrent or metastatic melanomaExperimentalCohort1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy
Receives: Drug: MGD013
Untreated mucosal or acral lentiginous melanomaExperimentalCohort2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma
Receives: Drug: MGD013

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of patients with a best response of CR or PR in enrolled patients, which is assessed by Independent Review Committee (IRC) per RECIST v1.1

    Measured: Approximately 12 months after dosed

Secondary outcomes (13)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1

    Measured: Approximately 12 months after dosed

  2. Objective Response Rate (ORR)

    Objective Response Rate (ORR) as assessed by Investigator and IRC per irRECIST.

    Measured: Approximately 12 months after dosed

  3. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from patient enrollment to death due to any cause

    Measured: Approximately 24 months

  4. Progression-free Survival (PFS)

    Progression-free Survival (PFS) is defined as the time from patient enrollment to tumor progression or death due to any cause. Progression is assessed per RECIST 1.1 and irRECIST criteria, respectively

    Measured: Approximately 12 months after dosed

  5. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the time from patient enrollment to tumor progression or death due to any cause. The tumor progression is assessed per RECIST 1.1 and irRECIST criteria, respectively

    Measured: Approximately 12 months after dosed

  6. Duration of Response (DoR)

    Duration of Response (DoR) is defined as the time from radiographic response to disease progression or death in patients with a best response of CR or PR, assessed per RECIST 1.1 and irRECIST criteria, respectively

    Measured: Approximately 12 months after dosed

  7. Survival Rate

    Survival Rate is defined as the proportion of surviving patients at the corresponding time point. Survival rates at 6 and 12 months will be analyzed in this study

    Measured: Approximately 12 months after dosed

  8. Incidence of Abnormal Laboratory value

    Incidence of abnormal laboratory is defined as the proportion of patients who have abnormal laboratory value not prior to the initiation of MGD013 administration

    Measured: Approximately 24 months

  9. Incidence of Adverse Events

    The incidence of adverse events is defined as the proportion of the patients who have adverse event(s) enrolled in this study.

    Measured: Approximately 24 months

  10. Incidence of Treatment-Emergent Adverse Events

    The incidence of treatment-emergent adverse event is defined as any event not present prior to the initiation of MGD013 treatment or any event already present that worsens in either intensity or frequency following exposure to MGD013 administration.

    Measured: Approximately 24 months.

  11. Maximum Serum Concentration (Cmax)

    The maximum serum concentration (Cmax, ng/ml) is defined as the maximum (or peak) serum concentration that MGD013 achieves in patients after the MGD013 administration at a corresponding timepoint.

    Measured: Approximately 3 months.

  12. Trough Serum Concentration (Ctrough)

    The through serum concentration (Cmin, ng/ml) is defined as the minimum (or through) serum concentration reached by MGD013 prior to administration of a second dose.

    Measured: Approximately 3 months

  13. Immunogenicity of MGD013

    Immunogenicity is defined as the positivity measured as the anti-MGD013 antibody induced in serum after MGD013 is administrated into human body at corresponding timepoints.

    Measured: Approximately 6 months after dosed

Timeline

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

  1. First posted4 Dec 2020
  2. Study start29 Oct 2020
  3. Primary completion2 Mar 2022
  4. Study completion2 Mar 2022

Why it stopped: rapid changes in the treatment mode of melanoma worldwide and in China and the development strategy change

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653038
Sponsor's protocol ID
ZL-1301-003
Status last verified
Jan 2024
First submitted
16 Nov 2020
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MGD013 in people with Unresectable, Recurrent or Metastatic Melanoma and Untreated Mucosal or Acral Lentiginous Melanoma, run by Zai Lab (Shanghai) Co., Ltd. at 13 sites in China.

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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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 was stopped early (reason given: rapid changes in the treatment mode of melanoma worldwide and in China and the development strategy change). Results are not available in the source record.

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?

Objective Response Rate (ORR) (time frame: Approximately 12 months after dosed). 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 NCT04653038.

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 29 Jan 2024.

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