Acral MelanomaPhase 3NCT05789043
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
A Phase 3 study testing camrelizumab+apatinib+TMZ, camrelizumab+apatinib and camrelizumab in people with Acral Melanoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acral Melanoma
- What is being tested?
- camrelizumab+apatinib+TMZ, camrelizumab+apatinib and camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 15 Feb 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
- age:≥18 years, male or female.
- Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
- Has not received any systematic anti-tumor drug treatment.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- ECOG 0-1.
- Adequate organ function.
- Life expectancy of greater than 12 weeks.
- Patient has given written informed consent.
Who cannot join
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
- Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Received a live vaccine within 4 weeks before the first dose of study medication.
- Pregnancy or breast feeding.
- Decision of unsuitableness by principal investigator or physician-in charge.
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
Jun Guo, guoj307@126.com
About this study
Official title: Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.
- Conditions
- Acral Melanoma
- Being tested
- camrelizumab+apatinib+TMZ, camrelizumab+apatinib, camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab+apatinib+TMZDrug
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28
camrelizumab+apatinibDrug
camrelizumab 200mg，q2w+apatinib 250mg qd
camrelizumabDrug
camrelizumab 200mg，q2w
| Study group | Role | What they receive |
|---|---|---|
| Three-drug arm | Experimental | Not described Receives: Drug: camrelizumab+apatinib+TMZ |
| Two-drug arm | Active comparator | Not described Receives: Drug: camrelizumab+apatinib |
| single-drug arm | Active comparator | Not described Receives: Drug: camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival, PFS
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: Within 2 years
Secondary outcomes (4)
Overall Survival ,OS
OS will be defined as the time from randomization to death due to any cause.
Measured: Within 2 years
ORR
The objective response rate will be assessed by RECIST 1.1
Measured: Within 2 years
DCR
The disease control rate will be assessed by RECIST 1.1
Measured: Within 2 years
Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment.
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start21 Mar 2023
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acral MelanomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Guo, Peking University Cancer Hospital & Institute
- Investigators
- Jun Guo, Dr, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789043
- Sponsor's protocol ID
- MA-MM-III-004
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05789043
- Acronym / sponsor ID
- MA-MM-III-004
- Conditions
- Acral Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 29 Mar 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.
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Three-drug arm | Experimental | Drug: camrelizumab+apatinib+TMZ |
| Two-drug arm | Active comparator | Drug: camrelizumab+apatinib |
| single-drug arm | Active comparator | Drug: camrelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age:≥18 years, male or female.
- Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
- Has not received any systematic anti-tumor drug treatment.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- ECOG 0-1.
Key exclusion criteria (7 listed)
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
- Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
- Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Received a live vaccine within 4 weeks before the first dose of study medication.
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 |
|---|---|---|
| camrelizumab+apatinib+TMZcamrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28 | Drug | Three-drug arm |
| camrelizumab+apatinibcamrelizumab 200mg，q2w+apatinib 250mg qd | Drug | Two-drug arm |
| camrelizumabcamrelizumab 200mg，q2w | Drug | single-drug arm |
Primary outcome
Progression Free Survival, PFS
Time frame: Within 2 years
PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first.
4 secondary outcomes
Overall Survival ,OS
Time frame: Within 2 years
ORR
Time frame: Within 2 years
DCR
Time frame: Within 2 years
Adverse Events (AEs)
Time frame: Within 2 years
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 6 Sep 2023.
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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.
Jun Guo, Dr principal investigator
Peking University Cancer Hospital & Institute
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 camrelizumab+apatinib+TMZ, camrelizumab+apatinib and camrelizumab in people with Acral Melanoma, run by Peking University Cancer Hospital & Institute 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 8 inclusion and 7 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 6 Sep 2023. 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 Jun Guo, Dr (010-88121122, guoj307@126.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: Within 2 years). 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 6 Sep 2023.