Acral Melanoma That Has Been Removed by SurgeryPhase 3NCT04277663
The Study of IBI310 in Combination With IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
A Phase 3 study testing IBI310+IBI308, IBI308 and High-dose recombinant interferon a-2B in people with Acral Melanoma That Has Been Removed by Surgery, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acral Melanoma That Has Been Removed by Surgery
- What is being tested?
- IBI310+IBI308, IBI308 and High-dose recombinant interferon a-2B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2020to 28 Feb 2023
- Phase
- Phase 3
- 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
- Sign the written informed consent (Informed Consent, ICF), and be able to abide by the visits and related procedures stipulated in the plan.
- Completely resected stage IIIB-IV acral melanoma (according to the 8th edition of AJCC staging criteria for malignant melanoma of the skin). Complete resection of stage III melanoma includes extended resection of the primary lesion and/or regional lymph node dissection and/or resection of satellite nodules. Complete resection of stage IV melanoma includes resection of primary tumor and complete resection of metastases. Complete resection of melanoma should conform to the principle of R0 resection and be confirmed by the investigator. Requirements for regional lymph node dissection refer to: upper extremity melanoma, at least 10 lymph nodes in the draining lymph node area; lower extremity melanoma, at least 5 lymph nodes in the draining lymph node area. In special cases, such as ① the long diameter of lymph nodes is ≥ 3 cm, it is considered that the number of lymph nodes can not be resected because of lymph node fusion; ② the draining lymph node area that needs to be cleaned only includes the cubital fossa or popliteal fossa, and the number of lymph nodes is difficult to reach 5-10, etc., it needs to be studied The patient confirmed whether the lymph node dissection was in line with R0 resection.
- Stage IIIB-IV acral melanoma with histologically/cytologically confirmed primary lesions in extremities (hands, feet, subungual nails). For subjects with only metastatic lesions confirmed by histopathology, researchers need to confirm that the primary lesions are in the extremities and exclude other primary sites, and they can discuss with the medical monitors to decide whether to enroll.
- The first study drug injection can only be carried out when the incision is completely healed after melanoma resection, and the injection time should not exceed 13 weeks after the operation (if the time limit is exceeded due to unforeseen reasons, it can be discussed with the medical supervisor decision to enroll).
- Within 4 weeks before randomization, R0 complete resection was confirmed by physical examination and imaging examination.
Who cannot join
- Mucosal-derived melanoma, ocular uveal melanoma, transitional metastasis and leptomeningeal metastasis.
- Previously exposed to any anti-CTLA-4, anti-PD-1 or anti-PD-L1/2 antibodies.
- Previous use of interferon. If interferon therapy was used ≥ 1 year before the first dose of study treatment, and the treatment time was ≤ 30 days or the treatment dose was ≤ 3×106IU/d, they could be enrolled.
- Hyperthyroidism or hypothyroidism, Note: Hypothyroidism subjects with stable condition after hormone replacement therapy can be enrolled.
- Participate in another clinical study at the same time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
This is a phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
- Being tested
- IBI310+IBI308, IBI308, High-dose recombinant interferon a-2B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI310+IBI308Drug
In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit.
IBI308Drug
In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit
High-dose recombinant interferon a-2BDrug
In this group, subjects will be given 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| IBI310 + IBI308 | Experimental | Participants will be treated with IBI310 in combination with IBI308 Receives: Drug: IBI310+IBI308 |
| IBI308 | Experimental | Participants will be treated with IBI308 Receives: Drug: IBI308 |
| high-dose recombinant interferon a-2B | Active comparator | Participants will be treated with recombinant interferon a-2B Receives: Drug: High-dose recombinant interferon a-2B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival rate
to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Measured: up to 5 years after enrollment
Secondary outcomes (1)
Overall survival (OS)
to evaluate the Overall survival (OS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
Measured: up to 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start17 Apr 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acral Melanoma That Has Been Removed by SurgeryStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277663
- Sponsor's protocol ID
- CIBI310A301
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2020
- Last updated
- 9 Mar 2023
- 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Multicenter Study, IBI310 in Combination With IBI308 and IBI308 Compared to High-Dose Interferon In Patients With Acral Melanoma That Has Been Removed by Surgery
- ClinicalTrials.gov ID
- NCT04277663
- Acronym / sponsor ID
- CIBI310A301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 20 Feb 2020 (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 phase III randomized, control, multi-center study of recombinant humanized anti-PD-1 mAb in combination with CTLA4 mAb for injection compared to high-Dose interferon in patients with acral melanoma that has been removed by surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI310 + IBI308 | Experimental | Drug: IBI310+IBI308Participants will be treated with IBI310 in combination with IBI308 |
| IBI308 | Experimental | Drug: IBI308Participants will be treated with IBI308 |
| high-dose recombinant interferon a-2B | Active comparator | Drug: High-dose recombinant interferon a-2BParticipants will be treated with recombinant interferon a-2B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the written informed consent (Informed Consent, ICF), and be able to abide by the visits and related procedures stipulated in the plan.
- Completely resected stage IIIB-IV acral melanoma (according to the 8th edition of AJCC staging criteria for malignant melanoma of the skin). Complete resection of stage III melanoma includes extended resection of the primary lesion and/or regional lymph node dissection and/or resection of satellite nodules. Complete resection of stage IV melanoma includes resection of primary tumor and complete resection of metastases. Complete resection of melanoma should conform to the principle of R0 resection and be confirmed by the investigator. Requirements for regional lymph node dissection refer to: upper extremity melanoma, at least 10 lymph nodes in the draining lymph node area; lower extremity melanoma, at least 5 lymph nodes in the draining lymph node area. In special cases, such as ① the long diameter of lymph nodes is ≥ 3 cm, it is considered that the number of lymph nodes can not be resected because of lymph node fusion; ② the draining lymph node area that needs to be cleaned only includes the cubital fossa or popliteal fossa, and the number of lymph nodes is difficult to reach 5-10, etc., it needs to be studied The patient confirmed whether the lymph node dissection was in line with R0 resection.
- Stage IIIB-IV acral melanoma with histologically/cytologically confirmed primary lesions in extremities (hands, feet, subungual nails). For subjects with only metastatic lesions confirmed by histopathology, researchers need to confirm that the primary lesions are in the extremities and exclude other primary sites, and they can discuss with the medical monitors to decide whether to enroll.
- The first study drug injection can only be carried out when the incision is completely healed after melanoma resection, and the injection time should not exceed 13 weeks after the operation (if the time limit is exceeded due to unforeseen reasons, it can be discussed with the medical supervisor decision to enroll).
- Within 4 weeks before randomization, R0 complete resection was confirmed by physical examination and imaging examination.
Key exclusion criteria (5 listed)
- Mucosal-derived melanoma, ocular uveal melanoma, transitional metastasis and leptomeningeal metastasis.
- Previously exposed to any anti-CTLA-4, anti-PD-1 or anti-PD-L1/2 antibodies.
- Previous use of interferon. If interferon therapy was used ≥ 1 year before the first dose of study treatment, and the treatment time was ≤ 30 days or the treatment dose was ≤ 3×106IU/d, they could be enrolled.
- Hyperthyroidism or hypothyroidism, Note: Hypothyroidism subjects with stable condition after hormone replacement therapy can be enrolled.
- Participate in another clinical study at the same time.
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 |
|---|---|---|
| IBI310+IBI308In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit. | Drug | IBI310 + IBI308 |
| IBI308In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit | Drug | IBI308 |
| High-dose recombinant interferon a-2BIn this group, subjects will be given 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks | Drug | high-dose recombinant interferon a-2B |
Primary outcome
Recurrence-free survival rate
Time frame: up to 5 years after enrollment
to evaluate the Recurrence free survival (RFS) of the patients with acral melanoma treated by IBI310 in Combination With IBI308 and high-Dose interferon
1 secondary outcome
Overall survival (OS)
Time frame: up to 5 years after enrollment
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 IBI310+IBI308, IBI308 and High-dose recombinant interferon a-2B in people with Acral Melanoma That Has Been Removed by Surgery, run by Innovent Biologics (Suzhou) Co. Ltd. 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 5 inclusion and 5 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 9 Mar 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?
The study was stopped early (reason given: Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators). 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?
Recurrence-free survival rate (time frame: up to 5 years after enrollment). 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 9 Mar 2023.