Malignant MelanomaPhase 2NCT04884997
A Study of Toripalimab or Combining With Temozolomide（iv） in the Treatment of Advanced/Metastatic Malignant Melanoma
A Phase 2 study testing toripalimab and Temozolomide Injection in people with Malignant Melanoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- toripalimab and Temozolomide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2021to 7 Sep 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Confirmed pathologic or cytologic diagnosis of advanced/metastatic malignant melanomawithout BRAF V600E mutation
- ECOG PS 0-1;
- Age :18 ~75 years old;
- There were measurable lesions according to RECIST 1.1 and the lesions that had been irradiated showed definite progression after radiotherapy and the lesion was considered measurable only if it was not the only lesion
- Proper function of the cardiovascular system, liver, kidney and bone marrow ;
- Subject with at most one systemic therapy for advanced/metastatic malignant melanoma
- Survival is expected to exceed 3 months
- The subjects showing good compliance voluntarily participated in the study and signed the informed consent
Who cannot join
- •Previously treated with TMZ, PD-1, or PD-L1;
- Complicated with other malignant tumors;
- Subjects with central nervous system metastases and/or cancerous meningitis;(Unless the subjects are asymptomatic or have been treated , no radiographic evidence of new BMs or BMs enlargement is found at least 2 weeks after BMs treatment.If the subjects have active or new untreated asymptomatic central nervous system (CNS) metastases found on imaging during the screening phase,they must receive radiotherapy
- Uncontrolled pleural effusion ,pericardial effusion or ascites requiring repeated drainage
- Received major surgical treatment or significant traumatic injury within Random 28 days prior
- Severe arterial/venous thrombosis events，Such as cerebrovascular accident (including temporary ischemic attack) ,deep vein thrombosis and pulmonary embolismwithin Random 6 months prior
Show all 20Show fewer
- Subjects with a history of psychotropic substance abuse and being unable to get rid of it or with mental disorders
- Subjects with any severe and/or uncontrolled disease,including :
- Subjects with poor blood pressure control (systolic≥ 150 mmHg or diastolic ≤100mmHg)
- Subjects with myocardial ischemia or myocardial infarction or arrhythmia above grade I (including male QTC ≥450ms(male) and female QTC ≥470ms) And ≥grade 2 congestive heart failure (New York Heart Association (NYHA))
- Active or uncontrolled severe infection (≥CTC AE grade 2 infection)
- liver cirrhosis,active hepatitis*;*active hepatitis(Hepatitis B reference: HBsAg positive, and HBV DNA test value exceeds the normal valueHepatitis C reference: HCV antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value
- HIV infected
- Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L)
- urine protein≥++,andConfirmated 24-hour urinary protein quantification>1.0 g
- Subjects received a preventive vaccineor attenuated vaccine within 4 weeks
- prior to first administration
- Participated in other clinical trials within 4 weeks
- Active autoimmune disease（Such as the following, but not limited to: autoimmune hepatitis interstitial pneumonia enteritis vasculitis, nephritis。Subjects with asthma requiring bronchodilators for medical intervention were not included） requiring systemic treatment（Such as the use of palliative drugs, corticosteroids, or immunosuppressants） occurred within 2 years prior to initial administration.Alternative therapy(Examples include thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy
- Other conditions that investigators consider the patients are not suitable
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Onocology, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
CHENG XIAO, MD, 87235896, 21218159@zju.edu.cn
About this study
Official title: An Exploratory Study of PD-1 Antibody(Toripalimab) or Combining With Temozolomide for Injection in the Treatment of Advanced/Metastatic Malignant Melanoma
This study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide
- Conditions
- Malignant Melanoma
- Being tested
- toripalimab, Temozolomide Injection
- Keywords
- malignant melanoma, PD-1 antibody, temozolomide for injection, toripalimab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toripalimabDrug
Also called triprizumab
toripalimab 3mg/kg, Q2w;
Temozolomide InjectionDrug
Also called Temoda
Temozolomide 150mg/m2,d1-5,Q4w
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | toripalimab 3mg/kg, Q2w; Receives: Drug: toripalimab |
| Arm B | Experimental | toripalimab 3mg/kg, Q2w; Temozolomide 150mg/m2,d1-5,Q4w Receives: Drug: toripalimab; Drug: Temozolomide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
objective response rate
Measured: 8 weeks
Secondary outcomes (7)
OS
overall survival
Measured: 3 years
PFS
Progression free survival
Measured: 1 years
DCR
Disease contral rate
Measured: 8 weeks
1-year PFS
progression free survival at 1 year (1year PFS) rate
Measured: 1 year after treatment initiation
6-month PFS
progression free survival at 6 months (6-month PFS) rate
Measured: 6 months after treatment initiation
1-year OS
overall survival at 1 year (1 year OS) rate
Measured: 1 year after treatment initiation
2-year OS
overall survival at 2 years (2 year OS) rate
Measured: 2 year after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start7 Mar 2021
- Primary completion7 Mar 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yulong Zheng, First Affiliated Hospital of Zhejiang University
- Investigators
- Yulong Zheng, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884997
- Sponsor's protocol ID
- IIT20210021C-R1
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 13 May 2021
- 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 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of PD-1 Antibody(Toripalimab) or Combining With Temozolomide for Injection in the Treatment of Advanced/Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT04884997
- Acronym / sponsor ID
- IIT20210021C-R1
- Conditions
- Malignant Melanoma
- Keywords
- malignant melanoma, PD-1 antibody, temozolomide for injection, toripalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 7 Mar 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 13 May 2021 (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 study evaluate toripalimab or combining with temozolomide for injection in the treatment of advanced/metastatic malignant melanoma. Participants in arm A receive toripalimab, in arm B receive toripalimab plus temozolomide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: toripalimabtoripalimab 3mg/kg, Q2w; |
| Arm B | Experimental | Drug: toripalimab, Drug: Temozolomide Injectiontoripalimab 3mg/kg, Q2w; Temozolomide 150mg/m2,d1-5,Q4w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- •Confirmed pathologic or cytologic diagnosis of advanced/metastatic malignant melanomawithout BRAF V600E mutation
Key exclusion criteria (20 listed)
- •Previously treated with TMZ, PD-1, or PD-L1;
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 |
|---|---|---|
| toripalimabAlso: triprizumabtoripalimab 3mg/kg, Q2w; | Drug | Arm A, Arm B |
| Temozolomide InjectionAlso: TemodaTemozolomide 150mg/m2,d1-5,Q4w | Drug | Arm B |
Primary outcome
ORR
Time frame: 8 weeks
objective response rate
7 secondary outcomes
OS
Time frame: 3 years
PFS
Time frame: 1 years
DCR
Time frame: 8 weeks
1-year PFS
Time frame: 1 year after treatment initiation
6-month PFS
Time frame: 6 months after treatment initiation
1-year OS
Time frame: 1 year after treatment initiation
2-year OS
Time frame: 2 year after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
Related trials for Malignant 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. This study is not recruiting at the moment.
Yulong Zheng, PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing toripalimab and Temozolomide Injection in people with Malignant Melanoma, run by First Affiliated Hospital of Zhejiang University 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 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: status not confirmed, as of the sponsor's last update on 13 May 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zheng, PhD (13588166206, drzhengyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 8 weeks). 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 13 May 2021.