Malignant MelanomaPhase 2NCT04924413
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
A Phase 2 study testing Tislelizumab in people with Malignant Melanoma, run by Quanli Gao at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. 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?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 2 Jul 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
- 1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.
- 8. Other tumor disease.
Who cannot join
- Symptomatic brain metastases
- Active infection
- Active HBV or HCV infection
- HIV infection
- Autoimmune disease
- Sensitive to drug or ingredients
- Severe mental disorders
- Sever disfunction of heart, liver and kidney
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.
- Conditions
- Malignant Melanoma
- Being tested
- Tislelizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called L-TIL
PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion
| Study group | Role | What they receive |
|---|---|---|
| L-TIL and Tislelizumab | Experimental | L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (ORR)
The objective response rate (ORR) at 8 weeks from baseline.
Measured: 8 weeks
Efficacy (ORR)
The objective response rate (ORR) at 16 weeks.
Measured: 16 weeks
Efficacy (DOR)
The duration of response (DOR) at 1-year.
Measured: 1 year
Efficacy (DOR)
The duration of response (DOR) at 2-year.
Measured: 2 years
Secondary outcomes (5)
Progression free survival (PFS)
The PFS rate at 1 year.
Measured: 1 year
Progression free survival (PFS)
The PFS rate at 2-year.
Measured: 2 years
Overall survival (OS)
The OS rate at 1 year.
Measured: 1 year
Overall survival (OS)
The OS rate at 2-year.
Measured: 2 years
Safety (adverse events)
The adverse events followed by treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jul 2021
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- L-TIL and Tislelizumab
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanli Gao
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Quanli Gao, Henan Cancer Hospital
- Investigators
- Quanli Gao, Ph.D, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924413
- Sponsor's protocol ID
- HenanCH L-TIL Melanoma
- Status last verified
- Jul 2024
- First submitted
- 31 May 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Zhao L, Yang Y, Wang Y, Zhang Y, Guo J, Chen G, Qin P, Xu B, Ma B, Zhang F, Shang Y, Li Q, Zhang K, Yuan D, Feng C, Ma Y, Liu Z, Tian Z, Li H, Wang S, Gao Q. T Cells Expanded from PD-1+ Peripheral Blood Lymphocytes Share More Clones with Paired Tumor-Infiltrating Lymphocytes. Cancer Res. 2021 Apr 15;81(8):2184-2194. doi: 10.1158/0008-5472.CAN-20-2300. Epub 2021 Jan 6.
PubMed 33408117
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT04924413
- Acronym / sponsor ID
- HenanCH L-TIL Melanoma
- Conditions
- Malignant Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Quanli GaoOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 14 Jun 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.
The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- L-TIL and Tislelizumab
| Arm | Type | Receives |
|---|---|---|
| L-TIL and Tislelizumab | Experimental | Drug: TislelizumabL-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.
- 8. Other tumor disease.
Key exclusion criteria (8 listed)
- Symptomatic brain metastases
- Active infection
- Active HBV or HCV infection
- HIV infection
- Autoimmune disease
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 |
|---|---|---|
| TislelizumabAlso: L-TILPD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion | Drug | L-TIL and Tislelizumab |
Primary outcome
Efficacy (ORR)
Time frame: 8 weeks
The objective response rate (ORR) at 8 weeks from baseline.
Efficacy (ORR)
Time frame: 16 weeks
The objective response rate (ORR) at 16 weeks.
Efficacy (DOR)
Time frame: 1 year
The duration of response (DOR) at 1-year.
Efficacy (DOR)
Time frame: 2 years
The duration of response (DOR) at 2-year.
5 secondary outcomes
Progression free survival (PFS)
Time frame: 1 year
Progression free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 years
Safety (adverse events)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 33408117Li T, Zhao L, Yang Y, Wang Y, Zhang Y, Guo J, Chen G, Qin P, Xu B, Ma B, Zhang F, Shang Y, Li Q, Zhang K, Yuan D, Feng C, Ma Y, Liu Z, Tian Z, Li H, Wang S, Gao Q. T Cells Expanded from PD-1+ Peripheral Blood Lymphocytes Share More Clones with Paired Tumor-Infiltrating Lymphocytes. Cancer Res. 2021 Apr 15;81(8):2184-2194. doi: 10.1158/0008-5472.CAN-20-2300. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Quanli Gao, Ph.D study director
Henan Cancer Hospital
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 Tislelizumab in people with Malignant Melanoma, run by Quanli Gao 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 2 inclusion and 8 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 3 Jul 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 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?
The study was stopped early (reason given: Slow enrollment). 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?
Efficacy (ORR) (time frame: 8 weeks). The study lists 4 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 NCT04924413, which also lists 1 linked publication.
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 3 Jul 2024.