MelanomaPhase 3NCT06008106
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
A Phase 3 study testing tunlametinib and paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
Trial summary
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- tunlametinib and paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2023to 22 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years of age.
- Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
- History of immunotherapy failure or could not tolerate immunotherapy
- NRAS mutation at baseline;.
- There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Eastern cooperative oncology group (ECOG) performance status of grade 0-1.
Show all 12Show fewer
- Life expectancy > 3 months.
- No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings.
- Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria:
- Able to understand and voluntarily sign the Informed Consent Form.
- Patients must be willing and able to complete the study procedure and follow-up examination.
Who cannot join
- Having the following treatment before receiving the study drug: ① received chemotherapy, targeted therapy or other study drug treatment within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer); ② received immunotherapy and biological therapy within 4 weeks before the first administration; ③ received traditional Chinese medicines with anti-tumor activities approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration.;
- The toxic reactions of previous anti-tumor treatment have not been recovered;
- Current use of other anti-cancer drugs.
- Subjects with symptomatic or untreated brain metastasis, meningeal metastasis or spinal cord compression except for subjects with asymptomatic brain metastasis;
- History of any of the following within 6 months of screening: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, severe heart arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident, or transient ischemic attack, diabetic ketoacidosis, deep vein thrombosis, or symptomatic pulmonary embolism.
- ECG Corrected Q-T interval formula (QTcB) ≥ 480 msec (adjusted by Bazett's formula) during screening, or a history of congenital long QT syndrome.
Show all 20Show fewer
- History or current evidence of retinal diseases;
- Previous or current neuromuscular diseases related to CK elevation;
- Previous or current interstitial lung disease or interstitial pneumonitis;
- Uncontrolled concomitant diseases or infectious diseases.
- Bleeding symptoms of grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the 4 weeks prior to study initiation.
- Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, external biliary diversion, or any small intestinal resection that would preclude adequate absorption of the study drug.
- Patients who are receiving and cannot discontinue regimen-prohibited intravenous or oral drugs that affect CYP isoenzymes (strong inducers and strong inhibitors of CYP2C9) at least 1 week prior to initiation of study treatment and during the study period.
- Patients with a history of malignancy within the past 5 years;
- Human immunodeficiency virus (HIV) antibody positive; syphilis antibody (anti-TP) positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; HBsAg positive and HBV DNA positive.
- Patients who have been previously treated with MEK inhibitors.
- Patients with known hypersensitivity to investigational drug, proposed chemotherapy or their analogues.
- History of allogeneic bone marrow transplantation or organ transplantation.
- Serum pregnancy test results are positive for premenopausal female patients;
- Other severe, acute, or chronic clinical or psychiatric disorders or laboratory abnormalities that may increase the risk and interfere with the study results in the opinion of investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, M.D., +86-10-88121122, guoj307@126.com
About this study
Official title: Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.
Read the detailed description
A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 2:1 ratio by Interactive Web Response System（IWRS）.
Experimental group: subjects received continuous administration of tunlametinib capsules every 28 days, and the study treatment was terminated until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigators, or when the study was terminated (whichever occurred earlier).
Control group: subjects received the combination chemotherapy (paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin, investigator's choice according to the conditions of the subjects) every 28 days until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigator or when the study was terminated (whichever occurred earlier).
Efficacy was evaluated by independent radiology review committee and the investigator, respectively.
Within 30 days after the last administration of the study drug, the safety of the subjects will also be closely monitored and recorded. After safety visit or the last administration of the study drug (whichever occurs later), subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death, lost to follow-up, withdrawal of informed consent, or the end of this study (whichever occurs earlier).
- Conditions
- Melanoma
- Being tested
- tunlametinib, paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin
- Keywords
- Mitogen-Activated Protein Kinase Kinases, NRAS, Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunlametinibDrug
12mg BID
paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatinDrug
according to investigators' suggestion
| Study group | Role | What they receive |
|---|---|---|
| tunlametinib | Experimental | Drug tunlametinib will be administered as 12mg BID Receives: Drug: tunlametinib |
| Assigned Interventions | Active comparator | combination chemotherapy Receives: Drug: paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival(PFS)
defined as the time from first dose to the earliest documented disease progression or death due to any cause
Measured: up to 12 months
Secondary outcomes (3)
Overall survival(OS)
defined as the time from the date of taking drugs to the date of death due to any cause
Measured: up to 12 months
Duration of response(DOR)
Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death
Measured: up to 12 months
Disease control rate(DCR)
Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start2 Nov 2023
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongqi Tian, phD, Study director, Shanghai Kechow Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008106
- Sponsor's protocol ID
- HL-085-301
- Status last verified
- Jun 2024
- First submitted
- 8 Aug 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy
- ClinicalTrials.gov ID
- NCT06008106
- Acronym / sponsor ID
- HL-085-301
- Conditions
- Melanoma
- Keywords
- Mitogen-Activated Protein Kinase Kinases, NRAS, Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- 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.
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.
Detailed description
A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 2:1 ratio by Interactive Web Response System（IWRS）.
Experimental group: subjects received continuous administration of tunlametinib capsules every 28 days, and the study treatment was terminated until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigators, or when the study was terminated (whichever occurred earlier).
Control group: subjects received the combination chemotherapy (paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin, investigator's choice according to the conditions of the subjects) every 28 days until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigator or when the study was terminated (whichever occurred earlier).
Efficacy was evaluated by independent radiology review committee and the investigator, respectively.
Within 30 days after the last administration of the study drug, the safety of the subjects will also be closely monitored and recorded. After safety visit or the last administration of the study drug (whichever occurs later), subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death, lost to follow-up, withdrawal of informed consent, or the end of this study (whichever occurs earlier).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tunlametinib | Experimental | Drug: tunlametinibDrug tunlametinib will be administered as 12mg BID |
| Assigned Interventions | Active comparator | Drug: paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatincombination chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥ 18 years of age.
- Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
- History of immunotherapy failure or could not tolerate immunotherapy
- NRAS mutation at baseline;.
- There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Key exclusion criteria (20 listed)
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 |
|---|---|---|
| tunlametinib12mg BID | Drug | tunlametinib |
| paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatinaccording to investigators' suggestion | Drug | Assigned Interventions |
Primary outcome
Progression-free Survival(PFS)
Time frame: up to 12 months
defined as the time from first dose to the earliest documented disease progression or death due to any cause
3 secondary outcomes
Overall survival(OS)
Time frame: up to 12 months
Duration of response(DOR)
Time frame: up to 12 months
Disease control rate(DCR)
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Melanoma
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
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Hongqi Tian, phD study director
Shanghai Kechow Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tunlametinib and paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 1 site 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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lixia Gong, Master (15800569407, gonglx@kechowpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival(PFS) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.